Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
Study NCT ID:
NCT07278466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The COMParing App Support Strategies Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 688}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire-9 (PHQ-9) Score', 'timeFrame': 'baseline, week 1, week 2, week 3, week 4, 6-month follow up', 'description': 'The PHQ-9 is an 9-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 is not at all to 3 is nearly every day. The total possible range of scores is 0-27 where higher scores indicate more depressive symptoms.'}, {'measure': 'Generalized Anxiety Disorder - 7 (GAD-7) Score', 'timeFrame': 'baseline, week 1, week 2, week 3, week 4, 6-month follow up', 'description': 'The GAD-7 is a 7-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale where 0 is not at all to 3 is nearly every day. The total possible range of scores is 0-21 where higher scores indicate more anxious symptoms.'}, {'measure': "Beck's Depression Inventory (BDI) Item 9 Score", 'timeFrame': 'baseline, week 1, week 2, week 3, week 4, 6-month follow up', 'description': 'scored from 0 (no suicidal thoughts) to 3 (severe suicidal thoughts)'}], 'secondaryOutcomes': [{'measure': 'Perceived Stress Scale (PSS) Score', 'timeFrame': 'baseline, week 1, week 2, week 3, week 4, 6-month follow up', 'description': 'The Perceived Stress Scale is a 10-item scale where participants report their level of perceived stress (e.g., "In the last month, how often have you felt nervous and \'stressed\'?"). It is scored on a 5-point Likert scale where 0 is "never" and 4 is "very often." Total scores range from 0 to 40 where higher scores indicate greater perceived stress.'}, {'measure': 'PROMIS Toolbox Meaning and Purpose Score', 'timeFrame': 'baseline, week 1, week 2, week 3, week 4, 6-month follow up', 'description': 'The PROMIS / NIH Toolbox Meaning and Purpose is a computer-adaptive measure where participants report how much meaning and purpose they experience in life (e.g., "I understand my life\'s meaning"). It is scored on a 5-point Likert scale where 1 = strongly disagree to 5 = strongly agree. It provides total scores as T-scores (mean = 50, SD = 10) where higher scores indicate more meaning and purpose in life.'}, {'measure': 'NIH Toolbox Loneliness Score', 'timeFrame': 'baseline, week 1, week 2, week 3, week 4, 6-month follow up', 'description': 'The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness.'}, {'measure': 'Five Facet Mindfulness Questionnaire (Awareness subscale) Score', 'timeFrame': 'baseline, week 1, week 2, week 3, week 4, 6-month follow up', 'description': 'The Five Facet Mindfulness Questionnaire Acting with Awareness Subscale is a 8-item subscale where participants report on their general ability to focus. It is scored on a 5-point Likert scale where 1 = never or very rarely true to 5 = very often or always true. The total possible range of scores is 8-40 where higher scores indicate a greater ability to focus.'}, {'measure': 'Experiences Questionnaire Decentering subscale Score', 'timeFrame': 'baseline, week 1, week 2, week 3, week 4, 6-month follow up', 'description': 'The Decentering subscale of the Experience Questionnaire is an 11-item questionnaire where participants report on their ability to decenter from their experience. It is scored on a 5-point Likert scale where 1 = never to 5 = all the time. The total possible range of scores is 11-55 where higher scores indicate a greater ability to decenter from experience.'}, {'measure': 'Perseverative Thinking Questionnaire (PTQ) Score', 'timeFrame': 'baseline, week 4, 6-month follow up', 'description': 'The PTQ is a self-report instrument assessing repetitive and uncontrolled thinking by asking participants to rate 15 items about the frequency, duration, and perceived uncontrollability of repetitive thoughts on a scale of 0-4. Scores range from 0 to 60. The higher the score, the higher the level of perseverative thinking or repetitive thoughts experienced by the individual.'}, {'measure': 'Healthy Minds Index (HM Index) - Awareness Score', 'timeFrame': 'baseline, week 4, 6-month follow up', 'description': 'The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Awareness subscale is 0 to 16 where higher scores indicate more awareness.'}, {'measure': 'Healthy Minds Index (HM Index) - Connection Score', 'timeFrame': 'baseline, week 4, 6-month follow up', 'description': 'The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Connection subscale range from 0 to 24, where higher scores indicate more connection.'}, {'measure': 'Healthy Minds Index (HM Index) - Insight Score', 'timeFrame': 'baseline, week 4, 6-month follow up', 'description': 'The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Insight subscale range from 0 to 12, where higher scores indicate more insight.'}, {'measure': 'Healthy Minds Index (HM Index) - Purpose Score', 'timeFrame': 'baseline, week 4, 6-month follow up', 'description': 'The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the Purpose subscale range from 0 to 16, where higher scores indicate more purpose.'}, {'measure': 'Growth Mindset Scale Adapted for Well-being Score', 'timeFrame': 'baseline, week 4, 6-month follow up', 'description': 'The Wellbeing Growth Mindset scale is a 3-item scale where participants report whether they believe wellbeing is malleable (e.g., "Your well-being is something about you that you can\'t change very much."). It is scored on a 6-point Likert scale where 1 is "strongly disagree" to 6 being "strongly agree." Total scores range from 3 to 18 where higher scores indicate greater wellbeing growth mindset.'}, {'measure': 'Digital Working Alliance Inventory (DWAI) Score', 'timeFrame': 'week 1, week 2, week 3, week 4', 'description': "DWAI is a six-item questionnaire designed to assess the working alliance within the Healthy Minds Program (HMP) app. It measures the user's connection and agreement with the app, focusing on the bond, tasks, and goals of the therapeutic relationship. It is scored on a 7-point Likert scale, with scores ranging from 6-42. Higher scores indicate a stronger working alliance with the HMP app."}, {'measure': 'Morning Daily Diary Items', 'timeFrame': 'Daily through the Intervention Period (up to 4 weeks)', 'description': 'Morning daily diary will include single-item measures of mindfulness, decentering, connection, purpose, depression, anxiety, happiness, energy, stress, busyness, rumination (2 items), sleep quality, motivation to practice meditation, and expectations and challenges related to using the HMP. Each item will be rated on a 5-point Likert scale (1 = not at all, 5 = very much). Higher scores indicate greater levels of the respective construct, such as higher mindfulness, greater decentering, stronger sense of purpose, greater happiness, more severe depression or anxiety, better sleep quality, or greater motivation and perceived helpfulness or frustration with HMP use that morning. Daily means with and standard deviations will be reported.'}, {'measure': 'Evening Daily Diary Items', 'timeFrame': 'Daily through the Intervention Period (up to 4 weeks)', 'description': 'Evening daily diary will include single-item measures of mindfulness, decentering, connection, purpose, depression, anxiety, happiness, energy, happy event, stress exposure, rumination (2 items), and expectations related to using the HMP. Each item will be rated on a 5-point Likert scale (1 = not at all, 5 = very much). Higher scores indicate greater levels of the respective construct, such as higher mindfulness, greater decentering, stronger sense of purpose, more severe depression or anxiety, happy event and stressor exposure experience, or greater motivation and perceived helpfulness with HMP use that day. Daily means with and standard deviations will be reported.'}, {'measure': 'Percentage of participants with a formal practice', 'timeFrame': 'Daily through the Intervention Period (up to 4 weeks)', 'description': "Participants' engagement in formal mindfulness practice will be assessed twice a day with a binary yes/no response. Formal practice is defined as using the HMP app."}, {'measure': 'Percentage of participants with an informal practice', 'timeFrame': 'Daily through the Intervention Period (up to 4 weeks)', 'description': "Participants' engagement in informal mindfulness practice will be assessed twice a day with a 5-point Likert scale (1 = not at all, 5 = all day long). Informal practice is defined as applying well-being practices in daily life."}, {'measure': 'Percentage of participants who received a text message and applied a well-being strategy', 'timeFrame': 'Daily through the Intervention Period (up to 4 weeks)', 'description': 'Participants will indicate whether they received a text message from the study that day (yes/no). If they respond "yes," they will then report whether the message encouraged them to apply a wellbeing strategy (yes/no) and rate the extent to which they applied the strategy in their day-to-day activities on a 5-point Likert scale (1 = not at all, 5 = very much).'}, {'measure': 'Extent to which participants applied a well-being strategy in their day-to-day activities', 'timeFrame': 'Daily through the Intervention Period (up to 4 weeks)', 'description': 'Participants who received a text message and applied a well-being strategy will be asked to rate the extent to which they applied the strategy in their day-to-day activities on a 5-point Likert scale (1 = not at all, 5 = very much).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HMP app', 'healthy minds program', 'Microsupport', 'meditation'], 'conditions': ['Depression, Anxiety']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://centerhealthyminds.org/', 'label': 'Center for Healthy Minds'}]}, 'descriptionModule': {'briefSummary': 'The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. The meditation app used is the Healthy Minds Program (HMP) which provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.', 'detailedDescription': 'Participants will be randomly assigned to various support conditions that vary across three binary factors,\n\n1. Introductory coaching session vs introductory information session\n2. On-demand email support (Yes/No)\n3. Microsupport messages (Yes/No)\n\nParticipants will be screened for eligibility using a web-based screener that assesses inclusion and exclusion criteria. Eligible participants will receive a study overview and will have the option to go through an online consent process. After giving consent, participant will receive a text message to assess their ability to receive text messages and tab on a link embedded in the text message. Those who failed to go through this process will be screened out.\n\nParticipants consented will complete a baseline survey consisting of a series of questionnaires and daily check-in assessment sent to their phone. Only those who successfully complete the baseline survey and the first daily check-in survey will advance in the study. Participants will schedule a meeting with our study staff member after completing the baseline survey and first daily check-in survey. They will be assessed through questionnaires at baseline, weekly during the 4-week intervention period, and at 6-month follow-up. They will also complete daily check-in survey twice a day throughout the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elevated symptoms of depression and/or anxiety (PHQ-9 greater than or equal to 10, GAD-7 greater than or equal to 10)\n* Proficiency in English\n* Access to a smartphone and internet\n* Ability to receive text messages\n\nExclusion Criteria:\n\n* Non-US citizen or legal resident (green card holder)\n* History of psychosis or mania\n* Suicidal ideation or thoughts of self-harm indicated by PHQ9 item 9 and BDI item 9\n* Individuals who do not provide the information required for GUID generation'}, 'identificationModule': {'nctId': 'NCT07278466', 'briefTitle': 'The COMParing App Support Strategies Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'The COMParing App Support Strategies Study', 'orgStudyIdInfo': {'id': '2025-1444'}, 'secondaryIdInfos': [{'id': 'Protocol Version 9/26/2025', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'EDUC/COUNSELING PSYCH', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '1R01MH139512-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH139512-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Introductory Coaching', 'interventionNames': ['Other: Introductory Coaching Session']}, {'type': 'EXPERIMENTAL', 'label': 'Introductory Coaching with On-Demand email support', 'interventionNames': ['Other: Introductory Coaching Session', 'Other: On-Demand Email Support']}, {'type': 'EXPERIMENTAL', 'label': 'Introductory Coaching and microsupport', 'interventionNames': ['Other: Introductory Coaching Session', 'Other: Microsupport']}, {'type': 'EXPERIMENTAL', 'label': 'Introductory Coaching with On-Demand email support and microsupport', 'interventionNames': ['Other: Introductory Coaching Session', 'Other: On-Demand Email Support', 'Other: Microsupport']}, {'type': 'EXPERIMENTAL', 'label': 'Introductory Information', 'interventionNames': ['Other: Introductory Information Session']}, {'type': 'EXPERIMENTAL', 'label': 'Introductory Information with On-Demand email support', 'interventionNames': ['Other: Introductory Information Session', 'Other: On-Demand Email Support']}, {'type': 'EXPERIMENTAL', 'label': 'Introductory Information and microsupport', 'interventionNames': ['Other: Introductory Information Session', 'Other: Microsupport']}, {'type': 'EXPERIMENTAL', 'label': 'Introductory Information with On-Demand email support and microsupport', 'interventionNames': ['Other: Introductory Information Session', 'Other: On-Demand Email Support', 'Other: Microsupport']}], 'interventions': [{'name': 'Introductory Coaching Session', 'type': 'OTHER', 'description': 'Participant is randomized to receive a 30-minute meditation coaching session', 'armGroupLabels': ['Introductory Coaching', 'Introductory Coaching and microsupport', 'Introductory Coaching with On-Demand email support', 'Introductory Coaching with On-Demand email support and microsupport']}, {'name': 'Introductory Information Session', 'type': 'OTHER', 'description': 'Participant is randomized to receive a 30-minute information session', 'armGroupLabels': ['Introductory Information', 'Introductory Information and microsupport', 'Introductory Information with On-Demand email support', 'Introductory Information with On-Demand email support and microsupport']}, {'name': 'On-Demand Email Support', 'type': 'OTHER', 'otherNames': ['email'], 'description': 'email support throughout the 4 week intervention period', 'armGroupLabels': ['Introductory Coaching with On-Demand email support', 'Introductory Coaching with On-Demand email support and microsupport', 'Introductory Information with On-Demand email support', 'Introductory Information with On-Demand email support and microsupport']}, {'name': 'Microsupport', 'type': 'OTHER', 'otherNames': ['text message'], 'description': 'Text message microsupport throughout the 4 week intervention period', 'armGroupLabels': ['Introductory Coaching and microsupport', 'Introductory Coaching with On-Demand email support and microsupport', 'Introductory Information and microsupport', 'Introductory Information with On-Demand email support and microsupport']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53703', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Center for Healthy Minds', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Wendy Lau, PhD', 'role': 'CONTACT', 'email': 'wendy.lau@wisc.edu', 'phone': '608-890-3073'}], 'overallOfficials': [{'name': 'Simon Goldberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW Madison'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}