Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 5:17 PM
Study NCT ID:
NCT05229406
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2022-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Healthy Minds Program App Dosage
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sbgoldberg@wisc.edu', 'phone': '608-265-8986', 'title': 'Simon B. Goldberg, PhD', 'organization': 'Center for Healthy Minds, University of Wisconsin - Madison'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study was not powered to detect between-group differences on pre-post outcomes. Here results are reported by arm for descriptive purposes.'}}, 'adverseEventsModule': {'timeFrame': 'up to 4 weeks on study', 'description': 'A single survey item was asked of participants "I had challenging, difficult, or distressing experiences as a result of my meditation during this study". Participants could answer Never, Rarely, Occasionally, Regularly, or Frequently. Please see Secondary Outcome Measures for count of participant responses.', 'eventGroups': [{'id': 'EG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Percentage of those randomized completing ecological momentary assessment (EMA) assessments and activities in the Healthy Minds Program (HMP) app', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Number of participants adhering to their assigned dosage greater than or equal to 50 percent of the days. This was assessed directly through the HMP app.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of EMA Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.71', 'spread': '32.82', 'groupId': 'OG000'}, {'value': '78.61', 'spread': '41.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Percentage of EMA assessments that were completed', 'unitOfMeasure': 'percentage of EMA assessments complete', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Study Completion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Percentage of participants completing pre- and post-test measures', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Completing Practices ≥50% of Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Number of participants completing practices ≥50% of days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Modified System Usability Scale (MSUS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.56', 'spread': '10.86', 'groupId': 'OG000'}, {'value': '83.66', 'spread': '14.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-test (week 4)', 'description': 'The MSUS is a 10-item questionnaire where participants report their experience of the usability of a product, in this case the HMP app. It is scored on a 1- to 5-point Likert scale where 1 = strongly disagree and 5 = strongly agree. The result was rescaled to range from 0 to 100 with higher scores indicate higher usability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'PRIMARY', 'title': 'Change in Attitudes Towards Psychological Online Interventions (ATPOI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'title': 'T1 Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.30', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '3.20', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'T2 Post-Test Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.45', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '3.47', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'The ATPOI is a 16-item questionnaire where participants report their perception of psychological online interventions. It is scored on a 1- to 5-point Likert scale where 1 = totally disagree and 5 = totally agree. Mean scores are reported for a total possible range of scores is 1 to 5 where higher scores indicate more positive attitudes towards psychological online interventions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'PRIMARY', 'title': 'HMP App Utilization: Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.85', 'spread': '66.13', 'groupId': 'OG000'}, {'value': '201.76', 'spread': '144.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Minutes of meditation practice completed', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HMP App Utilization: Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.28', 'spread': '7.00', 'groupId': 'OG000'}, {'value': '14.72', 'spread': '7.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Number of days the app was accessed.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'HMP App Utilization: Number of Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.65', 'spread': '32.40', 'groupId': 'OG000'}, {'value': '51.43', 'spread': '44.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-test (week 4)', 'unitOfMeasure': 'activities', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'title': 'T1 baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.93', 'spread': '5.38', 'groupId': 'OG000'}, {'value': '61.08', 'spread': '5.24', 'groupId': 'OG001'}]}]}, {'title': 'T2 post-test (week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.28', 'spread': '5.63', 'groupId': 'OG000'}, {'value': '56.78', 'spread': '6.02', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.58', 'spread': '4.32', 'groupId': 'OG000'}, {'value': '-4.44', 'spread': '7.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'Psychological distress will be computed as a composite of the PROMIS Depression and PROMIS Anxiety measures. We will use the computer adaptive version of both measures which have a mean of 50 and a standard deviation of 10. A composite will be computed by average across T-scores. T-scores range from 10 to 90 with higher scores indicating higher depression or anxiety.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'SECONDARY', 'title': 'Change in Healthy Minds Index (HM Index): Awareness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'title': 'T1 Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.29', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '3.26', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'T2 Post-Test Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.42', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'The HM Index assesses 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. There are 4 awareness items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more awareness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'SECONDARY', 'title': 'Change in Healthy Minds Index (HM Index): Connection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'title': 'T1 Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.56', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'T2 Post-Test Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.72', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '3.87', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'The HM Index assesses 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. There are 6 connection items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more connection.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'SECONDARY', 'title': 'Change in Healthy Minds Index (HM Index): Insight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'title': 'T1 Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.86', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'T2 Post-Test Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.11', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'The HM Index assesses 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. There are 3 insight items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more insight.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'SECONDARY', 'title': 'Change in Healthy Minds Index (HM Index): Purpose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'title': 'T1 Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.43', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '3.49', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'T2 Post-Test Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.80', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '3.88', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'The HM Index assesses 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. There are 4 purpose items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more purpose.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'SECONDARY', 'title': 'Change in Wellbeing Growth Mindset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'title': 'T1 Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.77', 'spread': '3.02', 'groupId': 'OG000'}, {'value': '13.48', 'spread': '2.99', 'groupId': 'OG001'}]}]}, {'title': 'T2 Post-time Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.60', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '15.11', 'spread': '2.63', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.68', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '2.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': "Well-being Growth Mindset is a 3-item questionnaire assessing participants' perception of the malleability of wellbeing. It is scored on a 1- to 6-point Likert scale where 1 = strongly disagree and 6 = strongly agree. Total scores range from 3 to 18 where higher scores indicate more of a growth mindset (i.e., wellbeing is malleable).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'SECONDARY', 'title': 'Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'title': 'T1 Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.04', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'T2 Post-test Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.22', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'FFMQ Awareness is a 8-item questionnaire assessing mindful awareness. It is scored on a 1- to 5-point Likert scale where 1 = never or very rarely true and 5 = very often or always true. Mean scores are reported with a range from 1 to 5 where higher scores indicate more mindful awareness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'SECONDARY', 'title': 'Change in NIH Toolbox Loneliness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'title': 'T1 Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.76', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '2.82', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'T2 Post-test Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.20', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '0.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'NIH Toolbox Loneliness is a 5-item questionnaire assessing loneliness. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = always. Mean scores are reported for a range from 1 to 5 where higher scores indicate more loneliness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'SECONDARY', 'title': 'Change in Experiences Questionnaire (EQ) Decentering Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'title': 'T1 Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.85', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '3.06', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'T2 Post-test Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.30', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '3.56', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'Experiences Questionnaire Decentering is an 11-item questionnaire assessing the psychological capacity of decentering. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = all the time. Mean scores are reported for a total range from 1 to 5 where higher scores indicate more decentering.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'SECONDARY', 'title': 'Change in Meaning in Life Questionnaire (MLQ) Presence Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'title': 'T1 Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.58', 'spread': '147', 'groupId': 'OG000'}, {'value': '3.62', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'T2 Post-test Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.27', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '4.53', 'spread': '1.31', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '1.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'MLQ Presence is a 5-item questionnaire assessing the presence of meaning in life. It is scored on a 1- to 7-point Likert scale where 1 = absolutely untrue and 7 = absolutely true. Mean scores are reported for a total range from 1 to 7 where higher scores indicate greater presence of meaning in life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'SECONDARY', 'title': 'Change in PROMIS Sleep Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'title': 'T1 Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.56', 'spread': '7.04', 'groupId': 'OG000'}, {'value': '53.77', 'spread': '5.81', 'groupId': 'OG001'}]}]}, {'title': 'T2 Post-Test Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.23', 'spread': '8.70', 'groupId': 'OG000'}, {'value': '48.84', 'spread': '8.19', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.20', 'spread': '6.72', 'groupId': 'OG000'}, {'value': '-5.04', 'spread': '9.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'Sleep disturbance will be assessed using the computer adaptive version of the PROMIS Sleep Disturbance measure. This measure produces scores a T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate greater sleep disturbance.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study'}, {'type': 'SECONDARY', 'title': 'Count of Participant Responses to Adverse Event Relevant Survey Item', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'OG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Rarely', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Occasionally', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Regularly', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Frequently', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 4 weeks', 'description': 'Participants were asked a single survey item to assess their meditation experience. The query was "I had challenging, difficult, or distressing experiences as a result of my meditation during this study." Participants chose from the following responses: Never, Rarely, Occasionally, Regularly, or Frequently. Count of participants in each arm answering each response is reported here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants withdrew from the study prior to the post-test measure, 1 participant did not answer the question'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in EMA-assessed Psychological Distress (Composite of Depression and Anxiety Items)', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item reflecting depression and a single item reflecting anxiety are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in EMA-assessed Mindfulness of Activities', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item mindfulness of activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in EMA-assessed Mindfulness of Feelings / Emotions', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing awareness of feelings is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in EMA-assessed Loneliness', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing loneliness is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in EMA-assessed Connection With Others', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing connection with others is scored on a 1- to 5-point Likert scale where 1 = not often at all and 5 = extremely often', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in EMA-assessed Decentering', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing decentering (i.e., experiencing thoughts more as events than direct reflection of reality) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in EMA-assessed Insight', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing insight is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in EMA-assessed Purpose', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing purpose is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in EMA-assessed Stressor Exposure', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing stressor exposure is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in EMA-assessed Personal Values / Meaning', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing reflection of personal values in current activity is scored on a 1- to 5-point Likert scale where 1 = not at all reflected and 5 = extremely reflected.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in EMA-assessed Rumination', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing rumination is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in EMA-assessed Informal Practice', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing application of meditation techniques in daily life (informal practice) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Pre- and Post-practice Positive Affect', 'timeFrame': 'Before and after meditation practices between baseline and post-test (week 4)', 'description': 'Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Pre- and Post-practice Negative Affect', 'timeFrame': 'Before and after meditation practices between baseline and post-test (week 4)', 'description': 'Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Post-practice Focus', 'timeFrame': 'Before and after meditation practices between baseline and post-test (week 4)', 'description': 'A single item assessing focus during meditation is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Digital Working Alliance Inventory (DWAI)', 'timeFrame': 'Post-test (week 4)', 'description': "The DWAI is a 6-item questionnaire assessing participants' alliance with the HMP app. It is scored on a 1- to 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Total scores range from 6 to 42 where higher scores indicate a stronger working alliance.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nHMP app: The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'FG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nHMP app: The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were enrolled from February 2022 to June 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '5-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'BG001', 'title': '15-minute App Usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.\n\nThe HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.72', 'spread': '11.48', 'groupId': 'BG000'}, {'value': '31.85', 'spread': '14.68', 'groupId': 'BG001'}, {'value': '31.28', 'spread': '13.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Other Gender', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'American Indian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Multiracial', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-19', 'size': 159812, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-08T11:03', 'hasProtocol': True}, {'date': '2023-06-06', 'size': 149762, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-08T11:05', 'hasProtocol': False}, {'date': '2022-02-03', 'size': 177309, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-06T12:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to two groups in a 1:1 ratio'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2022-01-27', 'resultsFirstSubmitDate': '2023-06-08', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-31', 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in EMA-assessed Psychological Distress (Composite of Depression and Anxiety Items)', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item reflecting depression and a single item reflecting anxiety are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.'}, {'measure': 'Change in EMA-assessed Mindfulness of Activities', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item mindfulness of activities is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.'}, {'measure': 'Change in EMA-assessed Mindfulness of Feelings / Emotions', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing awareness of feelings is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware.'}, {'measure': 'Change in EMA-assessed Loneliness', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing loneliness is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.'}, {'measure': 'Change in EMA-assessed Connection With Others', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing connection with others is scored on a 1- to 5-point Likert scale where 1 = not often at all and 5 = extremely often'}, {'measure': 'Change in EMA-assessed Decentering', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing decentering (i.e., experiencing thoughts more as events than direct reflection of reality) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.'}, {'measure': 'Change in EMA-assessed Insight', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing insight is scored on a 1- to 5-point Likert scale where 1 = not at all aware and 5 = extremely aware'}, {'measure': 'Change in EMA-assessed Purpose', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing purpose is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much'}, {'measure': 'Change in EMA-assessed Stressor Exposure', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing stressor exposure is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.'}, {'measure': 'Change in EMA-assessed Personal Values / Meaning', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing reflection of personal values in current activity is scored on a 1- to 5-point Likert scale where 1 = not at all reflected and 5 = extremely reflected.'}, {'measure': 'Change in EMA-assessed Rumination', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing rumination is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much'}, {'measure': 'Change in EMA-assessed Informal Practice', 'timeFrame': '4 times per day from baseline to post-test (week 4)', 'description': 'A single item assessing application of meditation techniques in daily life (informal practice) is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.'}, {'measure': 'Change in Pre- and Post-practice Positive Affect', 'timeFrame': 'Before and after meditation practices between baseline and post-test (week 4)', 'description': 'Two items assessing positive affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much.'}, {'measure': 'Change in Pre- and Post-practice Negative Affect', 'timeFrame': 'Before and after meditation practices between baseline and post-test (week 4)', 'description': 'Two items assessing negative affect are scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = very much'}, {'measure': 'Change in Post-practice Focus', 'timeFrame': 'Before and after meditation practices between baseline and post-test (week 4)', 'description': 'A single item assessing focus during meditation is scored on a 1- to 7-point Likert scale where 1 = not at all and 7 = most of the time'}, {'measure': 'Digital Working Alliance Inventory (DWAI)', 'timeFrame': 'Post-test (week 4)', 'description': "The DWAI is a 6-item questionnaire assessing participants' alliance with the HMP app. It is scored on a 1- to 7-point Likert scale where 1 = strongly disagree and 7 = strongly agree. Total scores range from 6 to 42 where higher scores indicate a stronger working alliance."}], 'primaryOutcomes': [{'measure': 'Randomization Rate: Number of Participants Who Were Randomized and Completed EMA Assessments and Activities in the HMP App', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Percentage of those randomized completing ecological momentary assessment (EMA) assessments and activities in the Healthy Minds Program (HMP) app'}, {'measure': 'Dosage Adherence: Number of Participants Adhering to Their Dosage Greater Than or Equal to 50 Percent of the Days', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Number of participants adhering to their assigned dosage greater than or equal to 50 percent of the days. This was assessed directly through the HMP app.'}, {'measure': 'Percentage of EMA Completed', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Percentage of EMA assessments that were completed'}, {'measure': 'Study Completion Rate', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Percentage of participants completing pre- and post-test measures'}, {'measure': 'Number of Participants Completing Practices ≥50% of Days', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Number of participants completing practices ≥50% of days'}, {'measure': 'Modified System Usability Scale (MSUS)', 'timeFrame': 'Post-test (week 4)', 'description': 'The MSUS is a 10-item questionnaire where participants report their experience of the usability of a product, in this case the HMP app. It is scored on a 1- to 5-point Likert scale where 1 = strongly disagree and 5 = strongly agree. The result was rescaled to range from 0 to 100 with higher scores indicate higher usability.'}, {'measure': 'Change in Attitudes Towards Psychological Online Interventions (ATPOI)', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'The ATPOI is a 16-item questionnaire where participants report their perception of psychological online interventions. It is scored on a 1- to 5-point Likert scale where 1 = totally disagree and 5 = totally agree. Mean scores are reported for a total possible range of scores is 1 to 5 where higher scores indicate more positive attitudes towards psychological online interventions.'}, {'measure': 'HMP App Utilization: Minutes', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Minutes of meditation practice completed'}, {'measure': 'HMP App Utilization: Days', 'timeFrame': 'Baseline to post-test (week 4)', 'description': 'Number of days the app was accessed.'}, {'measure': 'HMP App Utilization: Number of Activities', 'timeFrame': 'Baseline to post-test (week 4)'}], 'secondaryOutcomes': [{'measure': 'Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'Psychological distress will be computed as a composite of the PROMIS Depression and PROMIS Anxiety measures. We will use the computer adaptive version of both measures which have a mean of 50 and a standard deviation of 10. A composite will be computed by average across T-scores. T-scores range from 10 to 90 with higher scores indicating higher depression or anxiety.'}, {'measure': 'Change in Healthy Minds Index (HM Index): Awareness', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'The HM Index assesses 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. There are 4 awareness items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more awareness.'}, {'measure': 'Change in Healthy Minds Index (HM Index): Connection', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'The HM Index assesses 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. There are 6 connection items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more connection.'}, {'measure': 'Change in Healthy Minds Index (HM Index): Insight', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'The HM Index assesses 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. There are 3 insight items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more insight.'}, {'measure': 'Change in Healthy Minds Index (HM Index): Purpose', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'The HM Index assesses 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. There are 4 purpose items. Mean item scores are reported with a range from 0 to 4 where higher scores indicate more purpose.'}, {'measure': 'Change in Wellbeing Growth Mindset', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': "Well-being Growth Mindset is a 3-item questionnaire assessing participants' perception of the malleability of wellbeing. It is scored on a 1- to 6-point Likert scale where 1 = strongly disagree and 6 = strongly agree. Total scores range from 3 to 18 where higher scores indicate more of a growth mindset (i.e., wellbeing is malleable)."}, {'measure': 'Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'FFMQ Awareness is a 8-item questionnaire assessing mindful awareness. It is scored on a 1- to 5-point Likert scale where 1 = never or very rarely true and 5 = very often or always true. Mean scores are reported with a range from 1 to 5 where higher scores indicate more mindful awareness.'}, {'measure': 'Change in NIH Toolbox Loneliness', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'NIH Toolbox Loneliness is a 5-item questionnaire assessing loneliness. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = always. Mean scores are reported for a range from 1 to 5 where higher scores indicate more loneliness.'}, {'measure': 'Change in Experiences Questionnaire (EQ) Decentering Subscale', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'Experiences Questionnaire Decentering is an 11-item questionnaire assessing the psychological capacity of decentering. It is scored on a 1- to 5-point Likert scale where 1 = never and 5 = all the time. Mean scores are reported for a total range from 1 to 5 where higher scores indicate more decentering.'}, {'measure': 'Change in Meaning in Life Questionnaire (MLQ) Presence Subscale', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'MLQ Presence is a 5-item questionnaire assessing the presence of meaning in life. It is scored on a 1- to 7-point Likert scale where 1 = absolutely untrue and 7 = absolutely true. Mean scores are reported for a total range from 1 to 7 where higher scores indicate greater presence of meaning in life.'}, {'measure': 'Change in PROMIS Sleep Disturbance', 'timeFrame': 'Baseline, and post-test (week 4)', 'description': 'Sleep disturbance will be assessed using the computer adaptive version of the PROMIS Sleep Disturbance measure. This measure produces scores a T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate greater sleep disturbance.'}, {'measure': 'Count of Participant Responses to Adverse Event Relevant Survey Item', 'timeFrame': 'up to 4 weeks', 'description': 'Participants were asked a single survey item to assess their meditation experience. The query was "I had challenging, difficult, or distressing experiences as a result of my meditation during this study." Participants chose from the following responses: Never, Rarely, Occasionally, Regularly, or Frequently. Count of participants in each arm answering each response is reported here.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['depression', 'anxiety', 'behavioral symptoms'], 'conditions': ['Depression', 'Anxiety', 'Psychological Distress']}, 'referencesModule': {'references': [{'pmid': '40638276', 'type': 'DERIVED', 'citation': 'Dyer RL, Zimmerman KM, Zhao X, Xie Q, Dahl CJ, Quanbeck A, Goldberg SB. Developing meditation practice in individuals with elevated psychological distress via a meditation app intervention: An implementation science-informed qualitative investigation of barriers and facilitators. Psychol Serv. 2025 Jul 10:10.1037/ser0000980. doi: 10.1037/ser0000980. Online ahead of print.'}, {'pmid': '39070019', 'type': 'DERIVED', 'citation': 'Xie Q, Dyer RL, Lam SU, Frye C, Dahl CJ, Quanbeck A, Nahum-Shani I, Davidson RJ, Goldberg SB. Understanding the Implementation of Informal Meditation Practice in a Smartphone-Based Intervention: A Qualitative Analysis. Mindfulness (N Y). 2024 Feb;15(2):479-490. doi: 10.1007/s12671-024-02304-x. Epub 2024 Jan 22.'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate the effectiveness of the Healthy Minds Program (HMP) meditation app on participants experiencing depression and/or anxiety. Participants will be assigned to use the HMP app 5- or 15-minutes per day for 4 weeks.', 'detailedDescription': 'Depression and anxiety are highly common, but access to evidence-based treatments is limited. Meditation training delivered through mobile health (mHealth) technology may increase access to effective strategies. However, the necessary dosage of meditation practice to produce benefits is unknown. This project will investigate the feasibility, acceptability, and preliminary effectiveness of the HMP app for depression and/or anxiety and the feasibility of randomly assigning participants to practice dosages. Further, the project will provide a preliminary evaluation of the linkages between practice dosage and outcomes assessed retrospectively and in-the-moment via ecological momentary assessment (EMA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Access to a smartphone or device capable of downloading HMP app\n* Self-reported willingness to complete 1-2 min survey 4 times per day on phone for 4 weeks\n* Able to speak, read, and write in English\n* PROMIS Depression or PROMIS Anxiety \\>55\n\nExclusion Criteria:\n\n* Meditation retreat experience\n* Regular meditation practice (weekly practice for over 1 year OR daily practice within the previous 6 months)\n* Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course\n* PROMIS Depression \\>70\n* AUDIT C score greater than or equal to 4 for men, and greater than or equal to 3 for non-men (any other genders)'}, 'identificationModule': {'nctId': 'NCT05229406', 'briefTitle': 'Healthy Minds Program App Dosage', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Healthy Minds Program (HMP) App Dosage Study', 'orgStudyIdInfo': {'id': '2019-1578'}, 'secondaryIdInfos': [{'id': 'MSN227550', 'type': 'OTHER_GRANT', 'domain': 'UW Madison'}, {'id': '2019-1578', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'A171600', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'EDUC/COUNSELING PSYCH', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '01/21/2022', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '1K23AT010879-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23AT010879-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5-minute app usage', 'description': 'Participants will be asked to use the HMP app for 5-minutes per day.', 'interventionNames': ['Behavioral: HMP app']}, {'type': 'EXPERIMENTAL', 'label': '15-minute app usage', 'description': 'Participants will be asked to use the HMP app for 15-minutes per day.', 'interventionNames': ['Behavioral: HMP app']}], 'interventions': [{'name': 'HMP app', 'type': 'BEHAVIORAL', 'description': 'The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.', 'armGroupLabels': ['15-minute app usage', '5-minute app usage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Simon Goldberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data may be shared following analysis and publication or upon request.', 'ipdSharing': 'YES', 'description': 'Data will be de-identified and listed in public data registries (e.g., OSF) based on the publication of preregistered study hypotheses on a manuscript by manuscript basis.', 'accessCriteria': 'Researcher consent. Any reasonable request will be granted.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}