Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT04426318
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
COVID-19 and the Healthy Minds Program for Educators
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}, {'id': 'D064866', 'term': 'Mindfulness'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hirshberg@wisc.edu', 'phone': '608-262-0035', 'title': 'Matthew Hirshberg', 'organization': 'Center for Healthy Minds'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 16 weeks', 'description': 'Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \\<55, 55≥ \\<60, 60≥ \\<70, and ≥70; Pilkonis et al., 2011).', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.', 'otherNumAtRisk': 344, 'deathsNumAtRisk': 344, 'otherNumAffected': 344, 'seriousNumAtRisk': 344, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.', 'otherNumAtRisk': 318, 'deathsNumAtRisk': 318, 'otherNumAffected': 318, 'seriousNumAtRisk': 318, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'None to Slight Depression at Baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 175}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 160}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Depression at Baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 65}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Moderate Depression at Baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 87}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe Depression at Baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'None to Slight Depression at 4 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 218}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 172}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Depression at 4 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Moderate Depression at 4 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 61}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe Depression at 4 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'None to Slight Depression at 16 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 205}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 171}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Depression at 16 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 57}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Moderate Depression at 16 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 61}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe Depression at 16 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'None to Slight Anxiety at Baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 69}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Anxiety at Baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 99}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Moderate Anxiety at Baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 154}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 130}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe Anxiety at Baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'None to Slight Anxiety at 4 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 91}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Anxiety at 4 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 80}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Moderate Anxiety at 4 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 105}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe Anxiety at 4 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'None to Slight Anxiety at 16 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 100}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Anxiety at 16 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 80}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Moderate Anxiety at 16 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 96}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe Anxiety at 16 weeks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 344, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 318, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'Psychological distress will be assessed by aggregating 3 measures: PROMIS anxiety and PROMIS depression, and the NIH Toolbox Perceived Stress Scale. Averages will be z-scored with a mean of 0 and a standard deviation 1. Higher scores indicate increased psychological distress.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.80', 'spread': '5.93', 'groupId': 'OG000'}, {'value': '24.56', 'spread': '6.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.19', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '25.57', 'spread': '6.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.71', 'spread': '5.47', 'groupId': 'OG000'}, {'value': '25.69', 'spread': '6.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.45', 'spread': '5.61', 'groupId': 'OG000'}, {'value': '26.15', 'spread': '6.21', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.12', 'spread': '5.67', 'groupId': 'OG000'}, {'value': '26.12', 'spread': '6.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '5.32', 'groupId': 'OG000'}, {'value': '26.02', 'spread': '6.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'A measure of acting with mindful awareness. The total possible range in scores is 8-40, with higher scores indicating greater levels of this facet of mindfulness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Drexel Defusion Scale (DDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.83', 'spread': '7.89', 'groupId': 'OG000'}, {'value': '24.45', 'spread': '8.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.14', 'spread': '8.72', 'groupId': 'OG000'}, {'value': '26.26', 'spread': '8.31', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.45', 'spread': '8.42', 'groupId': 'OG000'}, {'value': '26.96', 'spread': '8.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.61', 'spread': '8.73', 'groupId': 'OG000'}, {'value': '27.52', 'spread': '9.07', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.43', 'spread': '8.54', 'groupId': 'OG000'}, {'value': '27.92', 'spread': '8.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.93', 'spread': '8.69', 'groupId': 'OG000'}, {'value': '28.23', 'spread': '8.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'Psychological distancing (i.e., defusion) will be assessed with the 10-item Drexel Defusion Scale (DDS). The total possible range in scores is 0-50, with higher scores indicating greater levels of psychological distancing.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Meaning in Life Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.20', 'spread': '5.44', 'groupId': 'OG000'}, {'value': '25.81', 'spread': '5.46', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.83', 'spread': '5.13', 'groupId': 'OG000'}, {'value': '26.02', 'spread': '5.38', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.15', 'spread': '5.14', 'groupId': 'OG000'}, {'value': '25.85', 'spread': '5.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.62', 'spread': '4.92', 'groupId': 'OG000'}, {'value': '26.13', 'spread': '5.83', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.85', 'spread': '5.35', 'groupId': 'OG000'}, {'value': '26.02', 'spread': '6.07', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.91', 'spread': '5.14', 'groupId': 'OG000'}, {'value': '26.29', 'spread': '5.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'The Meaning in Life Questionnaire Presence subscale will be used to measure perceptions of meaning and purpose in life. The total possible range in scores is 5 - 35 with higher scores indicating greater levels of meaning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the NIH Toolbox Loneliness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.53', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.34', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '2.49', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.16', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.07', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '2.33', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.13', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'A measure of loneliness (i.e, lack of social connectedness). The total possible range in scores is 1-5, representing the average across all items; higher scores indicate greater levels of loneliness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Conway COVID Questionnaire Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'Financial Subscale', 'categories': [{'measurements': [{'value': '3.09', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '2.02', 'groupId': 'OG001'}]}]}, {'title': 'News Subscale', 'categories': [{'measurements': [{'value': '4.03', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '4.10', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Proximity Subscale', 'categories': [{'measurements': [{'value': '3.16', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '2.99', 'spread': '1.66', 'groupId': 'OG001'}]}]}, {'title': 'Psychological Subscale', 'categories': [{'measurements': [{'value': '4.45', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '4.39', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Resource Subscale', 'categories': [{'measurements': [{'value': '2.13', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Symptoms Subscale', 'categories': [{'measurements': [{'value': '1.65', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Threat Subscale', 'categories': [{'measurements': [{'value': '5.05', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '5.03', 'spread': '1.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Conway COVID Questionnaire Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'Financial Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.10', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '2.02', 'groupId': 'OG001'}]}]}, {'title': 'News Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.67', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '3.66', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Proximity Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.36', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Psychological Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.96', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Resource Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.85', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Symptoms Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.57', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': 'Threat Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.64', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '4.74', 'spread': '1.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (post intervention)', 'description': 'The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Conway COVID Questionnaire Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'Financial Subscale', 'categories': [{'measurements': [{'value': '2.91', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '3.01', 'spread': '2.07', 'groupId': 'OG001'}]}]}, {'title': 'News Subscale', 'categories': [{'measurements': [{'value': '3.50', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '3.67', 'spread': '1.49', 'groupId': 'OG001'}]}]}, {'title': 'Proximity Subscale', 'categories': [{'measurements': [{'value': '4.45', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '4.56', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'Psychological Subscale', 'categories': [{'measurements': [{'value': '3.98', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '4.18', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Resource Subscale', 'categories': [{'measurements': [{'value': '1.81', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Symptoms Subscale', 'categories': [{'measurements': [{'value': '1.89', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '2.13', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'Threat Subscale', 'categories': [{'measurements': [{'value': '4.81', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '4.90', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks (3 months post-intervention)', 'description': 'The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Self-Compassion Scale Short Form Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.7', 'spread': '8.25', 'groupId': 'OG000'}, {'value': '35.2', 'spread': '8.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.1', 'spread': '8.75', 'groupId': 'OG000'}, {'value': '36.4', 'spread': '9.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.3', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '38.0', 'spread': '9.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'The Self-Compassion Scale Short Form will be used to measure self-compassion. The total possible range in scores is 12-60, with higher scores indicating greater levels of self-compassion.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Perseverative Thought Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.89', 'spread': '10.43', 'groupId': 'OG000'}, {'value': '29.62', 'spread': '11.29', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.75', 'spread': '10.71', 'groupId': 'OG000'}, {'value': '28.19', 'spread': '12.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.47', 'spread': '10.74', 'groupId': 'OG000'}, {'value': '25.91', 'spread': '12.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'Negative ruminative thinking will be measured with the Perseverative Thought Questionnaire. The total possible range in scores is 0-60, with higher scores indicating greater levels negative ruminative thinking.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.76', 'spread': '4.71', 'groupId': 'OG000'}, {'value': '12.47', 'spread': '4.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.07', 'spread': '4.33', 'groupId': 'OG000'}, {'value': '12.83', 'spread': '4.84', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.07', 'spread': '4.64', 'groupId': 'OG000'}, {'value': '12.59', 'spread': '4.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'Well-being will be measured using the WHO-5. The total possible range in scores is 0-25, with higher scores indicating greater levels of well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Neutral Face Rating Task: Prosocial Construal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.46', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '4.44', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': '4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.42', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': '16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.44', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '4.37', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'The Neutral Face Rating task is a novel measure of prosocial construal (average likability ratings) and race bias (average liking of white faces minus the average liking of black faces). Total score for prosocial construal is from 1 to 7, with higher scores representing greater prosocial construal.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Neutral Face Rating Task: Race Bias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': '4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': '16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'The Neutral Face Rating task is a novel measure of prosocial construal (average likability ratings) and race bias (average liking of white faces minus the average liking of black faces). Total score for race bias range from -6 to 6, with higher scores representing greater bias favoring white faces (negative scores on the bias measure indicate bias for liking black faces more than white faces).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Growth Mindset Scale for Well-Being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'OG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.00', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '4.94', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': '4 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.18', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '4.87', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 4 weeks (post intervention)', 'description': 'A measure of fixed versus incremental mindset regarding well-being. The average across items for a possible range in scores from 1-6 will be measured, with higher scores indicating greater levels of incremental views on well-being (i.e., it can be learned).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'not all participants returned surveys for each time point'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Slope Across Time on Practice Quality and Mood Items', 'timeFrame': 'Every other day when participant completes a practice (up to 4 weeks)', 'description': '4-tems following each app-based practice for treatment participants that ask about perceive quality of the practice, (1 poor, 9 very good), and mood (1 poor, 5 good).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Digital Working Alliance', 'timeFrame': 'After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only', 'description': 'A measure of working alliance in a digital environment that will be averaged across all items for a score range from 1 to 7, with higher scores reflecting higher levels of alliance.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'FG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '346'}, {'groupId': 'FG001', 'numSubjects': '320'}]}, {'type': 'Failed Attention Checks', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Downloaded HMP App', 'achievements': [{'groupId': 'FG000', 'numSubjects': '329'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Completed T2 Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '281'}, {'groupId': 'FG001', 'numSubjects': '280'}]}, {'type': 'Completed T3 Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '261'}, {'groupId': 'FG001', 'numSubjects': '274'}]}, {'type': 'Completed T4 Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '261'}, {'groupId': 'FG001', 'numSubjects': '275'}]}, {'type': 'Completed T5 Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '293'}]}, {'type': 'Completed T6 Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '286'}, {'groupId': 'FG001', 'numSubjects': '293'}]}, {'type': 'Final Intent to Treat Sample', 'achievements': [{'groupId': 'FG000', 'numSubjects': '344'}, {'groupId': 'FG001', 'numSubjects': '318'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '344'}, {'groupId': 'FG001', 'numSubjects': '318'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'failed attention checks and had their data removed from analyses', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '8321 Wisconsin school system employees invited, 1136 self-screened for eligibility, 353 ineligible (for prior medication, prior HMP app use, or depression t-score greater than 70), 698 consented, 32 did not complete a pre-test, 666 assigned to an arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '662', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.'}, {'id': 'BG001', 'title': 'Wait-list Control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'under 20 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '20-30 years', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': '30-40 years', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}, {'title': '40-50 years', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}]}, {'title': '50-60 years', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}, {'title': 'over 60 years', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '583', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Non-Binary', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were permitted to select more than one category.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian / Alaskan Native', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Asian / Pacific Islander', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Black / African American', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic / Latino', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'White / Caucasian', 'categories': [{'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '287', 'groupId': 'BG001'}, {'value': '602', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '344', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '662', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Highest Level of Education', 'classes': [{'title': 'less than 7 years formal education', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Graduated High School', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Some College', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Graduated College', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}, {'title': 'Advanced Degree', 'categories': [{'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Household Income', 'classes': [{'categories': [{'title': 'Less than $20,000', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': '$20,000 - $40,000', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': '$40,000 - $70,000', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}, {'title': '$70,000 - $100,000', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}, {'title': '$100,000 - $200,000', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}, {'title': 'greater than $200,000', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment Category', 'classes': [{'categories': [{'title': 'Classroom Teacher', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}, {'title': 'Classroom Support', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Special Education Teacher', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'School Support', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'School Administrator', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'System Staff', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Other / Unknown', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-26', 'size': 193420, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-26T11:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'There is no outcome assessor - all assessments will be conducted online by participants. Investigators will be blind to group assignment during data analysis. Analysis of hypotheses related to baseline characteristics, adherence and dosage cannot be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Random parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 698}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2020-06-09', 'resultsFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-08', 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Slope Across Time on Practice Quality and Mood Items', 'timeFrame': 'Every other day when participant completes a practice (up to 4 weeks)', 'description': '4-tems following each app-based practice for treatment participants that ask about perceive quality of the practice, (1 poor, 9 very good), and mood (1 poor, 5 good).'}, {'measure': 'Digital Working Alliance', 'timeFrame': 'After weeks 1, 2, and 3 during the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention) - Intervention group only', 'description': 'A measure of working alliance in a digital environment that will be averaged across all items for a score range from 1 to 7, with higher scores reflecting higher levels of alliance.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale', 'timeFrame': 'baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'Psychological distress will be assessed by aggregating 3 measures: PROMIS anxiety and PROMIS depression, and the NIH Toolbox Perceived Stress Scale. Averages will be z-scored with a mean of 0 and a standard deviation 1. Higher scores indicate increased psychological distress.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale', 'timeFrame': 'baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'A measure of acting with mindful awareness. The total possible range in scores is 8-40, with higher scores indicating greater levels of this facet of mindfulness.'}, {'measure': 'Change From Baseline on the Drexel Defusion Scale (DDS)', 'timeFrame': 'baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'Psychological distancing (i.e., defusion) will be assessed with the 10-item Drexel Defusion Scale (DDS). The total possible range in scores is 0-50, with higher scores indicating greater levels of psychological distancing.'}, {'measure': 'Change From Baseline on the Meaning in Life Questionnaire', 'timeFrame': 'baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'The Meaning in Life Questionnaire Presence subscale will be used to measure perceptions of meaning and purpose in life. The total possible range in scores is 5 - 35 with higher scores indicating greater levels of meaning.'}, {'measure': 'Change From Baseline on the NIH Toolbox Loneliness Scale', 'timeFrame': 'baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'A measure of loneliness (i.e, lack of social connectedness). The total possible range in scores is 1-5, representing the average across all items; higher scores indicate greater levels of loneliness.'}, {'measure': 'Conway COVID Questionnaire Subscale Scores', 'timeFrame': 'baseline', 'description': 'The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.'}, {'measure': 'Conway COVID Questionnaire Subscale Scores', 'timeFrame': '4 weeks (post intervention)', 'description': 'The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.'}, {'measure': 'Conway COVID Questionnaire Subscale Scores', 'timeFrame': '16 weeks (3 months post-intervention)', 'description': 'The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.'}, {'measure': 'Self-Compassion Scale Short Form Score', 'timeFrame': 'baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'The Self-Compassion Scale Short Form will be used to measure self-compassion. The total possible range in scores is 12-60, with higher scores indicating greater levels of self-compassion.'}, {'measure': 'Change From Baseline on the Perseverative Thought Questionnaire', 'timeFrame': 'baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'Negative ruminative thinking will be measured with the Perseverative Thought Questionnaire. The total possible range in scores is 0-60, with higher scores indicating greater levels negative ruminative thinking.'}, {'measure': 'Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale', 'timeFrame': 'baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'Well-being will be measured using the WHO-5. The total possible range in scores is 0-25, with higher scores indicating greater levels of well-being.'}, {'measure': 'Change From Baseline on the Neutral Face Rating Task: Prosocial Construal', 'timeFrame': 'baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'The Neutral Face Rating task is a novel measure of prosocial construal (average likability ratings) and race bias (average liking of white faces minus the average liking of black faces). Total score for prosocial construal is from 1 to 7, with higher scores representing greater prosocial construal.'}, {'measure': 'Change From Baseline on the Neutral Face Rating Task: Race Bias', 'timeFrame': 'baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)', 'description': 'The Neutral Face Rating task is a novel measure of prosocial construal (average likability ratings) and race bias (average liking of white faces minus the average liking of black faces). Total score for race bias range from -6 to 6, with higher scores representing greater bias favoring white faces (negative scores on the bias measure indicate bias for liking black faces more than white faces).'}, {'measure': 'Change From Baseline on the Growth Mindset Scale for Well-Being', 'timeFrame': 'baseline, 4 weeks (post intervention)', 'description': 'A measure of fixed versus incremental mindset regarding well-being. The average across items for a possible range in scores from 1-6 will be measured, with higher scores indicating greater levels of incremental views on well-being (i.e., it can be learned).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Depression', 'Psychological Stress', 'Psychological Distress', 'Well-being']}, 'referencesModule': {'references': [{'pmid': '34000843', 'type': 'RESULT', 'citation': 'Goldberg SB, Baldwin SA, Riordan KM, Torous J, Dahl CJ, Davidson RJ, Hirshberg MJ. Alliance With an Unguided Smartphone App: Validation of the Digital Working Alliance Inventory. Assessment. 2022 Sep;29(6):1331-1345. doi: 10.1177/10731911211015310. Epub 2021 May 18.'}, {'pmid': '37379444', 'type': 'RESULT', 'citation': 'Hirshberg MJ, Davidson RJ, Goldberg SB. Educators Are Not Alright: Mental Health During COVID-19. Educ Res. 2023 Jan;52(1):48-52. doi: 10.3102/0013189X221142595.'}, {'pmid': '39347788', 'type': 'DERIVED', 'citation': 'Goldberg SB, Bolt DM, Dahl CJ, Davidson RJ, Hirshberg MJ. Does it matter how meditation feels? An experience sampling study. J Consult Clin Psychol. 2024 Aug;92(8):531-541. doi: 10.1037/ccp0000857.'}, {'pmid': '37768631', 'type': 'DERIVED', 'citation': 'Webb CA, Hirshberg MJ, Gonzalez O, Davidson RJ, Goldberg SB. Revealing subgroup-specific mechanisms of change via moderated mediation: A meditation intervention example. J Consult Clin Psychol. 2024 Jan;92(1):44-53. doi: 10.1037/ccp0000842. Epub 2023 Sep 28.'}, {'pmid': '36346668', 'type': 'DERIVED', 'citation': 'Webb CA, Hirshberg MJ, Davidson RJ, Goldberg SB. Personalized Prediction of Response to Smartphone-Delivered Meditation Training: Randomized Controlled Trial. J Med Internet Res. 2022 Nov 8;24(11):e41566. doi: 10.2196/41566.'}], 'seeAlsoLinks': [{'url': 'https://osf.io/eqgt7', 'label': 'OSF Registry'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of a mid-size urban school district in the United States during the summer of 2020, in the midst of the novel coronavirus pandemic. A 3-month follow-up in the fall of 2020 will also be conducted.\n\nParticipants will be recruited via email and mailed postcards, and will first complete an online screen. Eligible participants will then enter a waiting zone for between 2-days and 2-weeks before they are sent the online pre-test. Upon completion of the pre-test, participants will be assigned to condition via a simple random number generator. If assigned to the intervention (i.e., the Healthy Minds Program App), participants will receive instructions and support in downloading and activating the app. Every 7-days over the 4-week intervention period participants in both conditions will complete the same set of measures. A full battery of measures will be administered a second time post-test, following the 4-week intervention period. Three-months after post-test, a follow-up assessment will be conducted.\n\nThe investigators predict that participants assigned to the intervention will demonstrate significantly reduced psychological distress after the intervention, and these decreases will persist at the 3-month follow-up. Further, it is hypothesized that baseline participant characteristics and early experience of the intervention will predict treatment adherence, study drop-out and outcomes, and that treatment engagement will moderate outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 years old and up\n* Employees of a K-12 school district in Wisconsin\n* Smartphone or device that can download apps from Google Play or the iTunes app store\n\nExclusion Criteria:\n\n* Individuals under 18 years old\n* Significant meditation experience:\n\n 1. Meditation retreat experience (meditation retreat or yoga/body practice retreat with significant meditation component),\n 2. Regular meditation practice weekly for over 1 year OR daily practice within the previous 6 months; or\n 3. Previous use of the HMP app.\n* Patient-Reported Outcomes Measurement Information System (PROMIS) depression score \\> 70'}, 'identificationModule': {'nctId': 'NCT04426318', 'acronym': 'CAHMP-ED', 'briefTitle': 'COVID-19 and the Healthy Minds Program for Educators', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'COVID-19 and the Healthy Minds Program for Educators', 'orgStudyIdInfo': {'id': '2020-0533'}, 'secondaryIdInfos': [{'id': 'A171600', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'EDUC/COUNSELING PSYCH', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Approval 10/15/2020', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Minds Program Foundations Training', 'description': 'Healthy Minds Program (HMP) Description:\n\nThe HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Richard Davidson, PhD. HMP is 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 high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP has \\>100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.', 'interventionNames': ['Behavioral: Healthy Minds Program Foundations Training']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control', 'description': 'Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing.'}], 'interventions': [{'name': 'Healthy Minds Program Foundations Training', 'type': 'BEHAVIORAL', 'otherNames': ['meditation', 'mindfulness'], 'description': 'The HMP is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. The program is unique in several ways. First, all program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). Second, in addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.', 'armGroupLabels': ['Healthy Minds Program Foundations Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be de-identified and made publicly available based on the publication of preregistered study hypotheses following peer review.', 'ipdSharing': 'YES', 'description': 'Data will be de-identified and listed in public data registries (i.e., 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': 'Chan Zuckerberg Initiative', 'class': 'OTHER'}, {'name': 'Healthy Minds Innovations', 'class': 'OTHER'}, {'name': 'Center for Healthy Minds', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}