Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-11 @ 7:21 PM
Study NCT ID:
NCT05524402
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2022-08-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jgreenberg5@mgh.harvard.edu', 'phone': '617-643-9402', 'title': 'Dr. Jonathan Greenberg', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the time of enrollment (0 weeks) through the follow-up assessment (3 months)', 'description': 'Adverse Event Monitoring: Throughout the study, subjects were monitored for the occurrence of adverse/other events. Lack of effect of treatment is not considered an event. All adverse events will be reported on an adverse event form. The Principle Investigator had the responsibility of reporting serious adverse events (death, life-threatening illness or injury, serious injury, or permanent disability) to PHRC within 24-72 hours of notification.', 'eventGroups': [{'id': 'EG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'title': 'Credibility Subscale', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Expectancy Subscale', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (0 Weeks)', 'description': 'Assessed using the Credibility and Expectancy Questionnaire (CEQ) which asks the participant indicate how much they believe, right now, that the intervention they will receive will help manage their concussion and related worry. Possible scores on both the credibility and expectancy subscales range from 3 to 27 and have a midpoint score of 14. The number of participants that scored at or above 14 on the credibility and/or expectancy subscales are reported below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total of participants (separated by condition) that scored above the midline on the credibility and expectancy subscales of the Credibility and Expectancy Questionnaire (CEQ).'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-Test (4 Weeks)', 'description': "Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The proportion of participants that completed the post-test and scored above the midpoint on the Client Satisfaction Scale.'}, {'type': 'PRIMARY', 'title': 'Feasibility of Recruitment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Outcome calculated for entire sample (TOR-C1 and TOR-C2; n=50).'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (0 Weeks)', 'description': 'Rate at which recruitment was possible', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The proportion of eligible patients (n=54) who agree to participate (n=50).'}, {'type': 'PRIMARY', 'title': 'Acceptability of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-Test (4 Weeks)', 'description': 'Rate at which program was accepted, measured by attendance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adherence to Homework', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Collected during intervention, an average of 4 weeks', 'description': "Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample represents the number of TOR-C1 program completers (i.e., those who attended at least 3 of 4 program sessions).'}, {'type': 'PRIMARY', 'title': 'Therapist Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'units': 'Program Sessions', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.30', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '97.60', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected during intervention, an average of 4 weeks', 'description': "Rate of interventionist's delivering the programs by following the established session topics and practices", 'unitOfMeasure': 'percentage of adherence', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Program Sessions', 'denomUnitsSelected': 'Program Sessions', 'populationDescription': '20% (n=10) of session recordings for each condition were randomly selected for clinician fidelity checks. The clinician is evaluated on the degree to which they delivered session content as intended with adequate clinical skills. Each subcomponent in each session is scored on a 1-5 point scale. The overall average score for the randomly selected TOR-C1 and TOR-C2 sessions is then assessed to produce an average percent of therapist adherence for each intervention.'}, {'type': 'PRIMARY', 'title': 'Feasibility of Assessments at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (0 Weeks)', 'description': "Rate of participant's completion of self-report measures, with no measures missing", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Feasibility of Assessments at Post-Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-Test (4 Weeks)', 'description': "Rate of participant's completion of self-report measures, with no measures missing", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Feasibility of Assessments at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Follow-up (12 Weeks)', 'description': "Rate of participant's completion of self-report measures, with no measures missing", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Collected during intervention, an average of 4 weeks', 'description': 'Any self reported or observed negative events related to participation', 'unitOfMeasure': 'Adverse events related to participation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Numerical Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'title': 'Baseline - During activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.12', 'spread': '2.91', 'groupId': 'OG000'}, {'value': '5.20', 'spread': '2.24', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - At rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.20', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '2.26', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test - During activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.91', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '2.27', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test - At rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.45', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '1.74', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up - During activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.40', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '2.10', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up - At rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '1.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': "Rate of a participant's pain at rest and with activity using a Likert scale with 0 being no pain and 10 being worst possible pain.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of measure completers (subject to change at each assessment point)'}, {'type': 'SECONDARY', 'title': 'Post-Concussion Symptom Scale (PCSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.52', 'spread': '31.26', 'groupId': 'OG000'}, {'value': '50.61', 'spread': '23.92', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.50', 'spread': '7.57', 'groupId': 'OG000'}, {'value': '29.08', 'spread': '24.05', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.65', 'spread': '11.26', 'groupId': 'OG000'}, {'value': '23.13', 'spread': '24.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': 'The PCSS measures post-concussion symptoms on a 1-6-point Linkert scale. Higher scores represent greater symptom severity and total scores can range from 22 to132 points.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of measure completers (subject to change at each assessment point)'}, {'type': 'SECONDARY', 'title': 'Generalized Anxiety Disorder Scale (GAD-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.00', 'spread': '4.85', 'groupId': 'OG000'}, {'value': '13.48', 'spread': '4.57', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.00', 'spread': '3.82', 'groupId': 'OG000'}, {'value': '7.92', 'spread': '5.27', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.85', 'spread': '3.70', 'groupId': 'OG000'}, {'value': '6.74', 'spread': '6.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': '7-item questionnaire measuring symptoms of anxiety within the past 2 weeks on a scale of 0 to 3. Total scores range from 0 to 21 and higher scores indicate more symptoms of anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of measure completers (subject to change at each assessment point)'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety And Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'title': 'Baseline - Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.46', 'spread': '3.63', 'groupId': 'OG000'}, {'value': '11.80', 'spread': '4.05', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.02', 'spread': '4.68', 'groupId': 'OG000'}, {'value': '8.22', 'spread': '4.02', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test - Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.81', 'spread': '4.22', 'groupId': 'OG000'}, {'value': '8.79', 'spread': '4.35', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test - Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.73', 'spread': '3.63', 'groupId': 'OG000'}, {'value': '5.13', 'spread': '2.63', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up - Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.80', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '8.39', 'spread': '5.22', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up - Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.10', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '5.12', 'spread': '2.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': 'Measures symptoms of emotional distress and estimates diagnoses. The scale has 14 items, 7 assess anxiety and 7 depression. Scores range from 0-21 on each subscale, wtih higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of measure completers (subject to change at each assessment point)'}, {'type': 'SECONDARY', 'title': 'World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.47', 'spread': '9.96', 'groupId': 'OG000'}, {'value': '16.29', 'spread': '8.80', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.61', 'spread': '6.32', 'groupId': 'OG000'}, {'value': '9.83', 'spread': '8.30', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.10', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '7.61', 'spread': '8.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': 'The WHODAS 2.0 measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is on the scale is measured 0-4, with total scores ranging from 0 to 48. Higher scores indicate more disability (worse outcomes).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of measure completers (subject to change at each assessment point)'}, {'type': 'SECONDARY', 'title': 'Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.01', 'spread': '11.50', 'groupId': 'OG000'}, {'value': '44.45', 'spread': '9.46', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.51', 'spread': '7.78', 'groupId': 'OG000'}, {'value': '36.02', 'spread': '12.02', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.20', 'spread': '9.80', 'groupId': 'OG000'}, {'value': '31.35', 'spread': '12.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': 'A 16-item questionnaire assessing beliefs about how work and physical activities affect mTBI symptoms, and whether they should be avoided on a scale of 0 to 3. Total scores range from 0 to 48 and higher scores represent higher fear avoidance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of measure completers (subject to change at each assessment point)'}, {'type': 'SECONDARY', 'title': 'Pain Catastophizing Scale (PCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.13', 'spread': '14.26', 'groupId': 'OG000'}, {'value': '20.64', 'spread': '14.78', 'groupId': 'OG001'}]}]}, {'title': 'Pose-Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.44', 'spread': '9.37', 'groupId': 'OG000'}, {'value': '14.46', 'spread': '13.41', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.80', 'spread': '9.57', 'groupId': 'OG000'}, {'value': '13.22', 'spread': '5.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': "A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Total scores range from 0 to 25 and higher scores indicate higher pain catastrophizing (worse outcomes).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of measure completers (subject to change at each assessment point)'}, {'type': 'SECONDARY', 'title': 'Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.31', 'spread': '5.39', 'groupId': 'OG000'}, {'value': '27.24', 'spread': '5.05', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.68', 'spread': '6.71', 'groupId': 'OG000'}, {'value': '30.21', 'spread': '6.74', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.65', 'spread': '4.80', 'groupId': 'OG000'}, {'value': '31.13', 'spread': '5.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': "Rate of a participant's broad conceptualization of mindfulness, items range from 1-4 and scores range from 12-48, with higher values reflecting higher levels of mindfulness", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of measure completers (subject to change at each assessment point)'}, {'type': 'SECONDARY', 'title': 'Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.88', 'spread': '7.22', 'groupId': 'OG000'}, {'value': '17.28', 'spread': '4.98', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.14', 'spread': '5.58', 'groupId': 'OG000'}, {'value': '11.00', 'spread': '6.41', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.99', 'spread': '4.30', 'groupId': 'OG000'}, {'value': '9.83', 'spread': '7.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': 'A 7-item subscale of the BRIQ measuring "limiting behaviors" (frequency of inactivity). This subscale is rated on a scale of 0 to 4, with total scores ranging from 0 to 28. Higher scores indicate more limiting behavior (worse outcomes).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of measure completers (subject to change at each assessment point)'}, {'type': 'SECONDARY', 'title': 'Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.'}, {'id': 'OG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.64', 'spread': '5.30', 'groupId': 'OG000'}, {'value': '12.84', 'spread': '5.24', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.19', 'spread': '5.79', 'groupId': 'OG000'}, {'value': '10.79', 'spread': '4.90', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.16', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '9.52', 'spread': '6.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': 'A 6-item subscale of the BRIQ measuring "all or nothing behaviors" (tendency for overexertion). This subscale is rated on a scale of 0 to 4, with higher scores indicating more all or nothing behavior. Total scores on this subscale range from 0 to 24.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of measure completers (subject to change at each assessment point)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'FG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Post-Test (4 Weeks)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Follow-Up (12 Weeks)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited via provider and self-referrals from the MGH Sports Concussion Clinic and Emergency Department, as well as concussion clinics nationwide, college health resources (e.g., sports medicine centers), relevant public social media sites (e.g., Facebook), Research Invitations via Patient Gateway after identifying potential participants through Research Patient Database Registry (RPDR) queries, and MGB Rally.', 'preAssignmentDetails': 'Of the 51 eligible patients, 50 enrolled and were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.\n\nTOR-C 1: TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.'}, {'id': 'BG001', 'title': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.\n\nTOR-C 2: TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.64', 'spread': '4.83', 'groupId': 'BG000'}, {'value': '23.28', 'spread': '4.56', 'groupId': 'BG001'}, {'value': '23.45', 'spread': '4.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Numerical Rating Scale - During Activity', 'classes': [{'categories': [{'measurements': [{'value': '4.12', 'spread': '2.91', 'groupId': 'BG000'}, {'value': '5.20', 'spread': '2.24', 'groupId': 'BG001'}, {'value': '4.66', 'spread': '2.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Rate of pain during activity using a Likert scale with 0 being no pain and 10 being worst possible pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Post-Concussion Symptom Scale', 'classes': [{'categories': [{'measurements': [{'value': '43.52', 'spread': '31.26', 'groupId': 'BG000'}, {'value': '50.61', 'spread': '23.92', 'groupId': 'BG001'}, {'value': '46.99', 'spread': '27.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Rate post-concussion symptoms on a 1 to 6-point Likert scale. Total scores range from 22 to 132, with higher scores indicating worse concussion symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Generalized Anxiety Disorder Scale (GAD-7)', 'classes': [{'categories': [{'measurements': [{'value': '10.00', 'spread': '4.85', 'groupId': 'BG000'}, {'value': '13.48', 'spread': '4.57', 'groupId': 'BG001'}, {'value': '11.74', 'spread': '4.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '7-item questionnaire measuring symptoms of anxiety within the past 2 weeks on a scale of 0 to 3. Total scores range from 0 to 21 and higher scores indicate more symptoms of anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale', 'classes': [{'categories': [{'measurements': [{'value': '9.46', 'spread': '3.63', 'groupId': 'BG000'}, {'value': '11.80', 'spread': '4.05', 'groupId': 'BG001'}, {'value': '10.63', 'spread': '3.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '7-item anxiety subscale of the Hospital Anxiety and Depression Scale. Scores range from 0-21, with higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)', 'classes': [{'categories': [{'measurements': [{'value': '13.47', 'spread': '9.96', 'groupId': 'BG000'}, {'value': '16.29', 'spread': '8.80', 'groupId': 'BG001'}, {'value': '14.88', 'spread': '9.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The WHODAS 2.0 measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is on the scale is measured 0-4, with total scores ranging from 0 to 48. Higher scores indicate more disability (worse outcomes).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)', 'classes': [{'categories': [{'measurements': [{'value': '39.01', 'spread': '11.50', 'groupId': 'BG000'}, {'value': '44.45', 'spread': '9.46', 'groupId': 'BG001'}, {'value': '41.80', 'spread': '10.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A 16-item questionnaire assessing beliefs about how work and physical activities affect mTBI symptoms, and whether they should be avoided on a scale of 0 to 3. Total scores range from 0 to 48 and higher scores represent higher fear avoidance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pain Catastrophizing Scale (PCS)', 'classes': [{'categories': [{'measurements': [{'value': '17.13', 'spread': '14.26', 'groupId': 'BG000'}, {'value': '20.64', 'spread': '14.78', 'groupId': 'BG001'}, {'value': '18.92', 'spread': '14.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Total scores range from 0 to 25 and higher scores indicate higher pain catastrophizing (worse outcomes).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)', 'classes': [{'categories': [{'measurements': [{'value': '29.31', 'spread': '5.39', 'groupId': 'BG000'}, {'value': '27.24', 'spread': '5.05', 'groupId': 'BG001'}, {'value': '28.28', 'spread': '5.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Measures participant's broad conceptualization of mindfulness, items range from 1-4 and total scores range from 12-48, with higher values reflecting higher levels of mindfulness", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale', 'classes': [{'categories': [{'measurements': [{'value': '11.64', 'spread': '5.30', 'groupId': 'BG000'}, {'value': '12.84', 'spread': '5.24', 'groupId': 'BG001'}, {'value': '12.24', 'spread': '5.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A 6-item subscale of the BRIQ measuring "all or nothing behaviors" (tendency for overexertion). This subscale is rated on a scale of 0 to 4, with higher scores indicating more all or nothing behavior. Total scores on this subscale range from 0 to 24.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hospital Anxiety And Depression Scale (HADS) - Depression Subscale', 'classes': [{'categories': [{'measurements': [{'value': '6.02', 'spread': '4.68', 'groupId': 'BG000'}, {'value': '8.22', 'spread': '4.02', 'groupId': 'BG001'}, {'value': '7.12', 'spread': '4.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '7-item depression subscale of the Hospital Anxiety and Depression Scale. Scores range from 0-21, with higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale', 'classes': [{'categories': [{'measurements': [{'value': '14.88', 'spread': '7.22', 'groupId': 'BG000'}, {'value': '17.28', 'spread': '4.98', 'groupId': 'BG001'}, {'value': '16.08', 'spread': '6.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A 7-item subscale of the BRIQ measuring "limiting behaviors" (frequency of inactivity). This subscale is rated on a scale of 0 to 4, with total scores ranging from 0 to 28. Higher scores indicate more limiting behavior (worse outcomes).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Numerical Rating Scale - At Rest', 'classes': [{'categories': [{'measurements': [{'value': '3.20', 'spread': '2.50', 'groupId': 'BG000'}, {'value': '3.72', 'spread': '2.26', 'groupId': 'BG001'}, {'value': '3.46', 'spread': '2.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Participant's pain at rest using a Likert scale with 0 being no pain and 10 being worst possible pain. Higher scores indicate worse pain severity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline analysis population is same as indicated in "Participant Flow".'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-22', 'size': 296042, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-28T11:30', 'hasProtocol': True}, {'date': '2024-05-22', 'size': 113395, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-28T11:27', 'hasProtocol': False}, {'date': '2024-03-26', 'size': 247334, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-28T10:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2022-08-17', 'resultsFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2022-08-29', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-03', 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)', 'timeFrame': 'Baseline (0 Weeks)', 'description': 'Assessed using the Credibility and Expectancy Questionnaire (CEQ) which asks the participant indicate how much they believe, right now, that the intervention they will receive will help manage their concussion and related worry. Possible scores on both the credibility and expectancy subscales range from 3 to 27 and have a midpoint score of 14. The number of participants that scored at or above 14 on the credibility and/or expectancy subscales are reported below.'}, {'measure': 'Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale', 'timeFrame': 'Post-Test (4 Weeks)', 'description': "Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction."}, {'measure': 'Feasibility of Recruitment', 'timeFrame': 'Baseline (0 Weeks)', 'description': 'Rate at which recruitment was possible'}, {'measure': 'Acceptability of Treatment', 'timeFrame': 'Post-Test (4 Weeks)', 'description': 'Rate at which program was accepted, measured by attendance.'}, {'measure': 'Adherence to Homework', 'timeFrame': 'Collected during intervention, an average of 4 weeks', 'description': "Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study."}, {'measure': 'Therapist Adherence', 'timeFrame': 'Collected during intervention, an average of 4 weeks', 'description': "Rate of interventionist's delivering the programs by following the established session topics and practices"}, {'measure': 'Feasibility of Assessments at Baseline', 'timeFrame': 'Baseline (0 Weeks)', 'description': "Rate of participant's completion of self-report measures, with no measures missing"}, {'measure': 'Feasibility of Assessments at Post-Test', 'timeFrame': 'Post-Test (4 Weeks)', 'description': "Rate of participant's completion of self-report measures, with no measures missing"}, {'measure': 'Feasibility of Assessments at Follow-up', 'timeFrame': 'Follow-up (12 Weeks)', 'description': "Rate of participant's completion of self-report measures, with no measures missing"}, {'measure': 'Adverse Events', 'timeFrame': 'Collected during intervention, an average of 4 weeks', 'description': 'Any self reported or observed negative events related to participation'}], 'secondaryOutcomes': [{'measure': 'Numerical Rating Scale', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': "Rate of a participant's pain at rest and with activity using a Likert scale with 0 being no pain and 10 being worst possible pain."}, {'measure': 'Post-Concussion Symptom Scale (PCSS)', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': 'The PCSS measures post-concussion symptoms on a 1-6-point Linkert scale. Higher scores represent greater symptom severity and total scores can range from 22 to132 points.'}, {'measure': 'Generalized Anxiety Disorder Scale (GAD-7)', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': '7-item questionnaire measuring symptoms of anxiety within the past 2 weeks on a scale of 0 to 3. Total scores range from 0 to 21 and higher scores indicate more symptoms of anxiety.'}, {'measure': 'Hospital Anxiety And Depression Scale (HADS)', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': 'Measures symptoms of emotional distress and estimates diagnoses. The scale has 14 items, 7 assess anxiety and 7 depression. Scores range from 0-21 on each subscale, wtih higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms.'}, {'measure': 'World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': 'The WHODAS 2.0 measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is on the scale is measured 0-4, with total scores ranging from 0 to 48. Higher scores indicate more disability (worse outcomes).'}, {'measure': 'Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': 'A 16-item questionnaire assessing beliefs about how work and physical activities affect mTBI symptoms, and whether they should be avoided on a scale of 0 to 3. Total scores range from 0 to 48 and higher scores represent higher fear avoidance.'}, {'measure': 'Pain Catastophizing Scale (PCS)', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': "A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Total scores range from 0 to 25 and higher scores indicate higher pain catastrophizing (worse outcomes)."}, {'measure': 'Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': "Rate of a participant's broad conceptualization of mindfulness, items range from 1-4 and scores range from 12-48, with higher values reflecting higher levels of mindfulness"}, {'measure': 'Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': 'A 7-item subscale of the BRIQ measuring "limiting behaviors" (frequency of inactivity). This subscale is rated on a scale of 0 to 4, with total scores ranging from 0 to 28. Higher scores indicate more limiting behavior (worse outcomes).'}, {'measure': 'Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale', 'timeFrame': 'Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks)', 'description': 'A 6-item subscale of the BRIQ measuring "all or nothing behaviors" (tendency for overexertion). This subscale is rated on a scale of 0 to 4, with higher scores indicating more all or nothing behavior. Total scores on this subscale range from 0 to 24.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MTBI - Mild Traumatic Brain Injury', 'Anxiety', 'Mindfulness'], 'conditions': ['MTBI - Mild Traumatic Brain Injury', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '33443484', 'type': 'BACKGROUND', 'citation': 'Greenberg J, Singh T, Iverson GL, Silverberg ND, Macklin EA, Parker RA, Giacino JT, Yeh GY, Vranceanu AM. A Live Video Mind-Body Treatment to Prevent Persistent Symptoms Following Mild Traumatic Brain Injury: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Jan 14;10(1):e25746. doi: 10.2196/25746.'}, {'pmid': '39505248', 'type': 'DERIVED', 'citation': 'Greenberg J, Levey NS, Becker M, Yeh GY, Giacino JT, Iverson G, Silverberg ND, Parker RA, Vranceanu AM. Feasibility Randomized Controlled Trial of the Toolkit for Optimal Recovery After Concussion: A Live Video Program to Prevent Persistent Concussion Symptoms in Young Adults With Anxiety. Arch Phys Med Rehabil. 2025 Apr;106(4):527-536. doi: 10.1016/j.apmr.2024.10.011. Epub 2024 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom).', 'detailedDescription': 'The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom).\n\nEach program will consist of four 45-minute sessions over the secure Zoom platform. Participants will receive a treatment manual. There are 3 assessment points consisting of self-report surveys: baseline, post program, and 3-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female outpatients, ages 18-35\n* English fluency and literacy\n* Diagnosed with a concussion in the past 10 weeks\n* Owns a smartphone or computer with Internet access\n* Willingness and ability to participate in four 45-minute program sessions and answer remote questionnaires before, after, and 3-month following the program\n* Free of concurrent psychotropic or have been on stable dosage for at least 6 weeks\n* Clinically significant anxiety symptoms (score ≥ 5 on GAD-7 anxiety scale)\n\nExclusion Criteria:\n\n* Previous history of moderate or severe TBI OR concussion in the past 2 years that resulted in symptoms lasting 3 months or more\n* Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)\n* Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder\n* Current substance abuse or dependence and current substance use disorder\n* Current active self-reported suicidal ideation\n* Practice of mindfulness techniques for greater than 45 minutes per week within the last 3 months\n* Participation in a mind-body or CBT treatment in the past 3 months\n* Currently pregnant'}, 'identificationModule': {'nctId': 'NCT05524402', 'briefTitle': 'Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI', 'orgStudyIdInfo': {'id': '2022P001521'}, 'secondaryIdInfos': [{'id': 'K23AT010653-01A1', 'link': 'https://reporter.nih.gov/quickSearch/K23AT010653-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TOR-C 1', 'description': 'TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.', 'interventionNames': ['Behavioral: TOR-C 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TOR-C 2', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.', 'interventionNames': ['Behavioral: TOR-C 2']}], 'interventions': [{'name': 'TOR-C 1', 'type': 'BEHAVIORAL', 'description': 'TOR-C 1 is an active intervention, adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program with weekly sessions and home practice.', 'armGroupLabels': ['TOR-C 1']}, {'name': 'TOR-C 2', 'type': 'BEHAVIORAL', 'description': 'TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.', 'armGroupLabels': ['TOR-C 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jonathan Greenberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jonathan Greenberg', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}