Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-22 @ 8:08 PM
Study NCT ID:
NCT06517394
Status:
COMPLETED
Last Update Posted:
2025-11-05
First Post:
2024-07-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open Pilot Trial of a Mind-body Program for Cardiac Arrest Survivors and Their Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'apresciutti@mgh.harvard.edu', 'phone': '6177267913', 'title': 'Principal investigator', 'organization': 'Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention: Survivors', 'description': "This arm represents the survivors that participated in the intervention.\n\nDyads of cardiac arrest survivors and their caregivers participated in 6 30-minute skills-based sessions. Sessions included provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist delivered all of the sessions. The main intervention goal was to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.\n\nRecovering Together after Cardiac Arrest: The intervention taught resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions took place in person or on Zoom/telephone, depending on the participant's preference and access to technology.", 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention: Caregivers', 'description': "This arm represents the caregivers that participated in the intervention.\n\nDyads of cardiac arrest survivors and their caregivers participated in 6 30-minute skills-based sessions. Sessions included provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist delivered all of the sessions. The main intervention goal was to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.\n\nRecovering Together after Cardiac Arrest: The intervention taught resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions took place in person or on Zoom/telephone, depending on the participant's preference and access to technology.", 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'dyads', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.\n\nRecovering Together after Cardiac Arrest: The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology."}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '0 weeks', 'description': 'Proportion of eligible CA survivor-caregiver dyads that enroll in the intervention amongst those who screen in to the study.', 'unitOfMeasure': 'dyads', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dyads', 'denomUnitsSelected': 'dyads', 'populationDescription': 'Analysis population (unit) was the dyad. We analyzed 8 dyads (8 survivors and 8 caregivers or 16 participants total).'}, {'type': 'PRIMARY', 'title': 'Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-test (0 weeks) to post-test (6 weeks)', 'description': 'Assessment feasibility was assessed by the number of individual participants (not dyads) that have no measures missing on all self-report questionnaires.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed 14 individual participants (7 survivors and 7 caregivers) for this benchmark, not dyads.'}, {'type': 'PRIMARY', 'title': 'Adherence Feasibility Assessed by the Number of CA Survivor-caregiver Dyads Who Begin the Intervention and Complete at Least 4 of 6 Intervention Sessions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}, {'units': 'dyads', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Pre-test (0 weeks) to post-test (6 weeks)', 'description': 'Adherence feasibility was assessed by the number of CA survivor-caregiver dyads who begin the intervention and adhere to it by completing at least 4 of 6 intervention sessions.', 'unitOfMeasure': 'dyads', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dyads', 'denomUnitsSelected': 'dyads', 'populationDescription': 'We analyzed 7 units (dyads), which is comprised of 14 participants (7 survivors and 7 caregivers).'}, {'type': 'PRIMARY', 'title': 'Therapist Fidelity Assessed by the Proportion of 9 Randomly Selected Sessions in Which the Study Clinician Delivered Fully Delivered All Key Session Content.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'Sessions', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Pre-test (0 weeks) to post-test (6 weeks)', 'description': 'Number of sessions in which the therapist adhered 100% to the treatment manual. The study coordinator listened to 9 random RT-CA sessions, and, using a checklist, identified whether the study clinician fully adhered to the content of each session by delivering each key ingredient of the session.', 'unitOfMeasure': 'Sessions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sessions', 'denomUnitsSelected': 'Sessions', 'populationDescription': 'Each unit of analysis was a session recording listened to at random by the research coordinator, which they rated the degree to which the study clinician delivered all key ingredients (rated as fully adherent or not adherent).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Client Satisfaction Score Greater Than the Midpoint (7.5).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-test (6 weeks)', 'description': 'The proportion of participants that scored above the midpoint on the Client Satisfaction Questionnaire-3 (CSQ-3), which assesses satisfaction with a program. Total scores range from 3-12 (midpoint 7.5); higher scores indicate greater satisfaction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was number of participants that scores above the midpoint on the CSQ-3, not dyads.'}, {'type': 'PRIMARY', 'title': 'Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'Survivors that endorsed credibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Caregivers that endorsed credibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Survivors that endorsed expectancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Caregivers that endorsed expectancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-test (0 weeks)', 'description': "Number of individuals that score above the midpoint on each sub-scale of the Credibility and Expectancy Questionnaire (CEQ). Through two subscales, the CEQ assesses participants' perceptions that a program is logical (credible) and their expectancy that participation would lead to improvements (expectancy). Scores on the credibility subscale range from 3-27 (midpoint 15) and scores on the expectancy factor range from 3-31 (midpoint 17); higher scores on each indicate greater credibility and expectancy.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For credibility and expectancy, we analyzed individual participant responses on each sub scale (Credibility and expectancy).'}, {'type': 'SECONDARY', 'title': 'Mean Change in the Hospital Depression and Anxiety Scale Total Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.6', 'groupId': 'OG000', 'lowerLimit': '-14.6', 'upperLimit': '-6.6'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.6', 'groupId': 'OG000', 'lowerLimit': '-11.2', 'upperLimit': '-1.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': 'Assesses emotional distress in medical patients; total scale ranges from 0-42, higher scores represent worse distress. A negative mean change in the total score means emotional distress improved.', 'unitOfMeasure': 'mean change units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed change in total score in individual survivors and caregivers'}, {'type': 'SECONDARY', 'title': 'Mean Change in Post-Traumatic Stress Disorder Checklist - 5 Total Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.6', 'groupId': 'OG000', 'lowerLimit': '-34', 'upperLimit': '-1.1'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'groupId': 'OG000', 'lowerLimit': '-11', 'upperLimit': '-1.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': '20-item questionnaire that measures post-traumatic stress disorder symptoms. Scores range from 0 to 80, with higher scores indicating greater severity and intensity of symptoms. A negative change in the total score represents improvement in symptoms.', 'unitOfMeasure': 'mean change units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed change in 7 survivors and 7 caregivers'}, {'type': 'SECONDARY', 'title': 'Mean Change in The Cognitive and Affective Mindfulness Scale-Revised Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '10.4'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '5.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': 'Measures dispositional mindfulness, total scores range from 12-48, higher values reflect higher levels of mindfulness. A positive mean change in the total score reflected increased dispositional mindfulness.', 'unitOfMeasure': 'mean change units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed change in 7 survivors and 7 caregivers'}, {'type': 'SECONDARY', 'title': 'Mean Change in Enhancing Recovery in Coronary Heart Disease Social Support Inventory Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '4.8'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '3.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': '7-item measure that assesses perceived social support. Higher scores indicate greater social support. Total scores range from 8 to 34. A positive mean change in the total score indicates increases in perceived social support.', 'unitOfMeasure': 'change in units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed change in 7 survivors and 7 caregivers'}, {'type': 'SECONDARY', 'title': 'Mean Change in Measure of Current Status Part A (MOCS-A) Average Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.9'}]}]}, {'title': 'caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': 'Assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Higher scores indicate a stronger ability to recognize stress and cope. Scores are averaged and range from 0-4. A positive change in the MOCS-A average score indicates improvements in coping.', 'unitOfMeasure': 'change in units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed change in 7 survivors and 7 caregivers'}, {'type': 'SECONDARY', 'title': 'Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'survivors phys QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '5.3'}]}]}, {'title': 'caregivers phys QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '0.4'}]}]}, {'title': 'survivors psych QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '2.4'}]}]}, {'title': 'caregivers psych QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '1.5'}]}]}, {'title': 'survivors soc QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '3.3'}]}]}, {'title': 'caregivers soc QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '0.8'}]}]}, {'title': 'survivors env QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '0.5'}]}]}, {'title': 'caregivers env QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': '26-item measure assessing quality of life across four domains: physical health, psychological health, social relationships, and environment. Higher scores indicate higher quality of life for all domains. Scores in each domain range from 4 to 20. Scores were assessed at pre- and post-test; a positive mean change score in each domain indicates improved quality f life.', 'unitOfMeasure': 'change in units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '7 survivors and 7 caregivers'}, {'type': 'SECONDARY', 'title': 'Mean Change in Dyadic Relationship Scale Sub Scales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'survivors positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-5.1', 'upperLimit': '5.1'}]}]}, {'title': 'caregivers positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '1.8'}]}]}, {'title': 'survivors strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '3.7'}]}]}, {'title': 'caregivers strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': 'Questionnaire that assesses perceptions of dyadic interactions from both members of the relationship. The caregiver version is 11 items and the patient version is 10 items. Scores are calculated for two subscales: dyadic strain (scores range from 0-15) and positive interactions (scores range from 0-18). Lower scores on the dyadic strain subscale and greater scores on the positive interactions subscale indicate fewer relationship stressors and more positive aspects of the relationship.', 'unitOfMeasure': 'change in units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '7 survivors 7 caregivers'}, {'type': 'SECONDARY', 'title': 'Mean Change in Dyadic Coping Inventory Sub Scales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'Survivors stress communicated by oneself', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '3.5'}]}]}, {'title': 'Caregivers stress communicated by oneself', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.2'}]}]}, {'title': 'Survivors stress communicated by partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '4.9'}]}]}, {'title': 'Caregivers stress communicated by partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '3.3'}]}]}, {'title': 'Survivors supportive coping provided by partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '7.4'}]}]}, {'title': 'Caregivers supportive coping provided by partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '-3.9', 'upperLimit': '7.6'}]}]}, {'title': 'Survivors negative dyadic coping by partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.1'}]}]}, {'title': 'Caregivers negative dyadic coping by partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '6.2'}]}]}, {'title': 'Survivors common dyadic coping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '6'}]}]}, {'title': 'Caregivers common dyadic coping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '4.2'}]}]}, {'title': 'Survivors evaluation of dyadic coping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '7.4'}]}]}, {'title': 'Caregivers evaluation of dyadic coping', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '2.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': "Measures perceived quality of dyad's communication and proficiency in using adaptive dyadic coping skills. Subscales are summed for a total subscale score. Higher scores indicate greater quality communication and/or coping.\n\nStress communicated by oneself measures how well stress is communicated by oneself to their partner Range 4-20.\n\nStress communicated by one's partner Measures how well one's partner communicates about their stress. Range 4-20.\n\nSupportive coping provided by one's partner Measures the quality of emotional and/or problem-focused support provided by one's partner Range 5-25.\n\nNegative dyadic coping by one's partner Measures the degree that one's partner uses hostile, ambivalent, and superficial actions/words that have deleterious intentions. Range 4-20.\n\nJoint or common coping Measures the degree to which dyads work together to manage stress.Range 5-25.\n\nEvaluation of dyadic coping Measures perception of the quality of the dyad's approach to coping.Range 2-10.", 'unitOfMeasure': 'change in units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed change in 7 survivors and 7 caregivers'}, {'type': 'SECONDARY', 'title': 'Mean Change in Applied Mindfulness Scale Total Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-11.9', 'upperLimit': '7.1'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '9.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': '15-item questionnaire measuring how participants use mindfulness when facing stressors. Scores range from 0 to 60 with higher scores indicating greater use of mindfulness practices.', 'unitOfMeasure': 'change in units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '7 survivors 7 caregivers'}, {'type': 'SECONDARY', 'title': 'Mean Change in Preparedness for Caregiving Scale Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '12'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '9.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': 'For caregivers, this scale measures caregiver preparedness to care for survivor. In this study, for survivor participants, we adapted the language to measure preparedness to care for oneself. Scores range from 0 to 32 Higher scores indicate greater perceived readiness for caregiving (for caregivers) or for survivorship (for survivors).', 'unitOfMeasure': 'change in units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '7 survivors 7 caregivers'}, {'type': 'SECONDARY', 'title': 'Mean Change in Meaning in Life Questionnaire Sub Scales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'Survivors presence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-5.6', 'upperLimit': '1.1'}]}]}, {'title': 'Caregivers presence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '3.4'}]}]}, {'title': 'Survivors search', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-13.9', 'upperLimit': '4'}]}]}, {'title': 'Caregivers search', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-2.4', 'upperLimit': '3.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': '10 items measuring presence of meaning and purpose in life. Assesses two dimensions: presence and search. Items are rated on a 7-point scale from 1 (Absolutely Untrue) to 7 (Absolutely True). Both presence of meaning and search for meaning subscale scores range from 5-35. Higher scores indicate greater presence and search.', 'unitOfMeasure': 'change in units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '7 survivors 7 caregivers'}, {'type': 'SECONDARY', 'title': 'Gratitude Questionnaire Six Item Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-2.6', 'upperLimit': '0.9'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '3.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': "Measures participant's gratitude disposition. Each item is rated on a 7-point Likert scale. Scores range from 6 to 42. Higher scores indicate a more grateful disposition.", 'unitOfMeasure': 'change in units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '7 survivors 7 caregivers'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '7 dyads enrolled (7 survivors and 7 caregivers for a total of 14 participants).', 'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '7 dyads completed (7 survivors and 7 caregivers for a total of 14 participants).', 'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '14 total participants (7 dyads) participated'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': '14 total participants (7 dyads) participated'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': '14 total participants (7 dyads) participated'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': '14 total participants (7 dyads) participated'}, {'title': 'Marital Status', 'classes': [{'title': 'Survivors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Marital status (married)', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': '14 total participants (7 dyads) participated'}], 'populationDescription': '14 total participants (7 dyads) participated'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-30', 'size': 412716, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-20T17:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2024-07-18', 'resultsFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-21', 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Feasibility Assessed by the Number of Eligible Dyads Enrolled', 'timeFrame': '0 weeks', 'description': 'Proportion of eligible CA survivor-caregiver dyads that enroll in the intervention amongst those who screen in to the study.'}, {'measure': 'Assessment Feasibility Assessed by the Number of Participants With no Measures Missing on All Self-report Questionnaires.', 'timeFrame': 'Pre-test (0 weeks) to post-test (6 weeks)', 'description': 'Assessment feasibility was assessed by the number of individual participants (not dyads) that have no measures missing on all self-report questionnaires.'}, {'measure': 'Adherence Feasibility Assessed by the Number of CA Survivor-caregiver Dyads Who Begin the Intervention and Complete at Least 4 of 6 Intervention Sessions.', 'timeFrame': 'Pre-test (0 weeks) to post-test (6 weeks)', 'description': 'Adherence feasibility was assessed by the number of CA survivor-caregiver dyads who begin the intervention and adhere to it by completing at least 4 of 6 intervention sessions.'}, {'measure': 'Therapist Fidelity Assessed by the Proportion of 9 Randomly Selected Sessions in Which the Study Clinician Delivered Fully Delivered All Key Session Content.', 'timeFrame': 'Pre-test (0 weeks) to post-test (6 weeks)', 'description': 'Number of sessions in which the therapist adhered 100% to the treatment manual. The study coordinator listened to 9 random RT-CA sessions, and, using a checklist, identified whether the study clinician fully adhered to the content of each session by delivering each key ingredient of the session.'}, {'measure': 'Number of Participants With Client Satisfaction Score Greater Than the Midpoint (7.5).', 'timeFrame': 'Post-test (6 weeks)', 'description': 'The proportion of participants that scored above the midpoint on the Client Satisfaction Questionnaire-3 (CSQ-3), which assesses satisfaction with a program. Total scores range from 3-12 (midpoint 7.5); higher scores indicate greater satisfaction.'}, {'measure': 'Credibility and Expectancy Assessed by the Number of Individuals That Score Above the Midpoint on Each Sub-scale of the Credibility and Expectancy Questionnaire', 'timeFrame': 'Pre-test (0 weeks)', 'description': "Number of individuals that score above the midpoint on each sub-scale of the Credibility and Expectancy Questionnaire (CEQ). Through two subscales, the CEQ assesses participants' perceptions that a program is logical (credible) and their expectancy that participation would lead to improvements (expectancy). Scores on the credibility subscale range from 3-27 (midpoint 15) and scores on the expectancy factor range from 3-31 (midpoint 17); higher scores on each indicate greater credibility and expectancy."}], 'secondaryOutcomes': [{'measure': 'Mean Change in the Hospital Depression and Anxiety Scale Total Score.', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': 'Assesses emotional distress in medical patients; total scale ranges from 0-42, higher scores represent worse distress. A negative mean change in the total score means emotional distress improved.'}, {'measure': 'Mean Change in Post-Traumatic Stress Disorder Checklist - 5 Total Score.', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': '20-item questionnaire that measures post-traumatic stress disorder symptoms. Scores range from 0 to 80, with higher scores indicating greater severity and intensity of symptoms. A negative change in the total score represents improvement in symptoms.'}, {'measure': 'Mean Change in The Cognitive and Affective Mindfulness Scale-Revised Total Score', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': 'Measures dispositional mindfulness, total scores range from 12-48, higher values reflect higher levels of mindfulness. A positive mean change in the total score reflected increased dispositional mindfulness.'}, {'measure': 'Mean Change in Enhancing Recovery in Coronary Heart Disease Social Support Inventory Total Score', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': '7-item measure that assesses perceived social support. Higher scores indicate greater social support. Total scores range from 8 to 34. A positive mean change in the total score indicates increases in perceived social support.'}, {'measure': 'Mean Change in Measure of Current Status Part A (MOCS-A) Average Score.', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': 'Assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Higher scores indicate a stronger ability to recognize stress and cope. Scores are averaged and range from 0-4. A positive change in the MOCS-A average score indicates improvements in coping.'}, {'measure': 'Mean Change in the World Health Organization Quality of Life-Brief Sub Scale Scores', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': '26-item measure assessing quality of life across four domains: physical health, psychological health, social relationships, and environment. Higher scores indicate higher quality of life for all domains. Scores in each domain range from 4 to 20. Scores were assessed at pre- and post-test; a positive mean change score in each domain indicates improved quality f life.'}, {'measure': 'Mean Change in Dyadic Relationship Scale Sub Scales', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': 'Questionnaire that assesses perceptions of dyadic interactions from both members of the relationship. The caregiver version is 11 items and the patient version is 10 items. Scores are calculated for two subscales: dyadic strain (scores range from 0-15) and positive interactions (scores range from 0-18). Lower scores on the dyadic strain subscale and greater scores on the positive interactions subscale indicate fewer relationship stressors and more positive aspects of the relationship.'}, {'measure': 'Mean Change in Dyadic Coping Inventory Sub Scales', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': "Measures perceived quality of dyad's communication and proficiency in using adaptive dyadic coping skills. Subscales are summed for a total subscale score. Higher scores indicate greater quality communication and/or coping.\n\nStress communicated by oneself measures how well stress is communicated by oneself to their partner Range 4-20.\n\nStress communicated by one's partner Measures how well one's partner communicates about their stress. Range 4-20.\n\nSupportive coping provided by one's partner Measures the quality of emotional and/or problem-focused support provided by one's partner Range 5-25.\n\nNegative dyadic coping by one's partner Measures the degree that one's partner uses hostile, ambivalent, and superficial actions/words that have deleterious intentions. Range 4-20.\n\nJoint or common coping Measures the degree to which dyads work together to manage stress.Range 5-25.\n\nEvaluation of dyadic coping Measures perception of the quality of the dyad's approach to coping.Range 2-10."}, {'measure': 'Mean Change in Applied Mindfulness Scale Total Score.', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': '15-item questionnaire measuring how participants use mindfulness when facing stressors. Scores range from 0 to 60 with higher scores indicating greater use of mindfulness practices.'}, {'measure': 'Mean Change in Preparedness for Caregiving Scale Total Score', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': 'For caregivers, this scale measures caregiver preparedness to care for survivor. In this study, for survivor participants, we adapted the language to measure preparedness to care for oneself. Scores range from 0 to 32 Higher scores indicate greater perceived readiness for caregiving (for caregivers) or for survivorship (for survivors).'}, {'measure': 'Mean Change in Meaning in Life Questionnaire Sub Scales', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': '10 items measuring presence of meaning and purpose in life. Assesses two dimensions: presence and search. Items are rated on a 7-point scale from 1 (Absolutely Untrue) to 7 (Absolutely True). Both presence of meaning and search for meaning subscale scores range from 5-35. Higher scores indicate greater presence and search.'}, {'measure': 'Gratitude Questionnaire Six Item Form', 'timeFrame': 'Pre-test (0 weeks), Post-Test (6 weeks)', 'description': "Measures participant's gratitude disposition. Each item is rated on a 7-point Likert scale. Scores range from 6 to 42. Higher scores indicate a more grateful disposition."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emotional Distress', 'Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '41062056', 'type': 'DERIVED', 'citation': 'Presciutti AM, La Camera D, Perman SM, Elmer J, Donnino MW, Wu O, Parker RA, Vranceanu AM. Single-arm feasibility trial of a resilience intervention for cardiac arrest survivors and their family caregivers, Recovering Together after Cardiac Arrest. Resuscitation. 2025 Nov;216:110855. doi: 10.1016/j.resuscitation.2025.110855. Epub 2025 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to pilot a mind-body intervention for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest. The data the investigators gather in this study will be used to further refine our intervention.', 'detailedDescription': 'The goal of this study is to refine our proposed intervention Recovering Together after Cardiac Arrest (RT-CA) through an open pilot. The investigators will deliver an open pilot of the intervention (N=5 dyads; 10 participants total) to evaluate initial feasibility and acceptability using exit interviews and pre-post assessments.\n\nThe open pilot will take place at Massachusetts General Hospital intensive care units and step-down units. Study clinicians will deliver 6, 30 minute sessions of the intervention (at bedside or on Zoom/telephone, depending on participant preference and access). All participants will complete measures at baseline, and after completion of program (6 weeks). At the completion of the program, participants will engage in an exit interview where they will provide feedback of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Out-of-hospital or in-hospital CA survivor (must have new diagnosis of "cardiac arrest" in electronic medical record from index hospitalization with documented loss of pulse) with an identified caregiver (identified by the survivor who is their primary source of emotional and functional support)\n2. Score ≥4 on Short Form of the Mini Mental State Exam\n3. Ability and willingness to participate in a hybrid in-person/live video or phone intervention\n4. English speaking adults, 18 years or older\n5. At least one member of the dyad endorses clinically significant emotional distress during screening (\\>7 on Hospital Anxiety and Depression Scale subscales)\n\nExclusion Criteria:\n\n1\\. Active psychosis, mania, substance dependence, or suicidal intent or plan'}, 'identificationModule': {'nctId': 'NCT06517394', 'briefTitle': 'Open Pilot Trial of a Mind-body Program for Cardiac Arrest Survivors and Their Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Open Pilot Trial of a Dyadic Mind-body Program for Cardiac Arrest Survivors and Their Caregivers: Recovering Together After Cardiac Arrest', 'orgStudyIdInfo': {'id': '2024P001877'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Dyads will participate in 6 30-minute skills-based sessions. Sessions will also include provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress.', 'interventionNames': ['Behavioral: Recovering Together after Cardiac Arrest']}], 'interventions': [{'name': 'Recovering Together after Cardiac Arrest', 'type': 'BEHAVIORAL', 'description': "The intervention will teach resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions will take place in person or on Zoom/telephone, depending on the participant's preference and access to technology.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Alexander M Presciutti, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alexander Presciutti', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}