NCT04595084|CompletedDMC
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Sponsor study identifier
Secondary identifiers
interventional
113
1 country
1
Study Start
March 15, 2021
Actual (reported)Primary Completion
March 6, 2023
Actual (reported)Study Completion
March 6, 2023
Actual (reported)This 3-arm study compares the effectiveness of an (1) 8-week mindfulness-based intervention, MBCT-R (Mindfulness-Based Cognitive Therapy for Resilience During COVID-19)+CHA MindWell vs. (2) iCBT (internet based Cognitive Behavioral Therapy)+ CHA MindWell vs. (3) CHA MindWell remote monitoring and telephone coaching alone on depressive symptoms as measured over the course of 24-weeks by the computerized adaptive mental health (CAT-MH) interview for depression (CAT-DI). Secondary outcomes include rates and levels of alcohol and drug use, as well as the number of required mental health clinician visits (televisits and in-person visits). Exploratory outcomes include stress-related affect reactivity and salivary inflammatory markers (e.g., interleukin-6).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 6, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2020
Actual (reported)October 20, 2020
Actual (reported)March 15, 2021
Actual (reported)March 6, 2023
Actual (reported)March 6, 2023
Actual (reported)Depression Severity (CAT-DI)
Change in depression symptom severity as measured by CAT-MH Depression Inventory (DI) scores completed at baseline and every 4 weeks during the 24 weeks after randomization. Difference between MBCT-R arm and CHA-MW monitoring alone arm is primary outcome. Difference between iCBT arm and CHA-MW monitoring alone arm is secondary outcome. Difference between iCBT arm and MBCT-R is an exploratory outcome.
Baseline, Weeks 4, 8, 12, 16, 20, 24
Drug Use Rates
Week 24
Heavy Drinking Days
Week 24
Mindfulness-Based Cognitive Therapy (MBCT) is an effective group intervention for depression and anxiety that combines mindfulness training with elements of cognitive therapy. This will be delivered with CHAMindWell mental wellness monitoring with CAT-MH and telephone coaching as needed.
MoodGym is a form of iCBT, which an evidence-based online program for depression, anxiety, stress and general psychological well-being. This will be delivered with CHAMindWell mental wellness monitoring with CAT-MH and telephone coaching as needed.
MBCT-R is designed to foster resilience and prevent new-onset anxiety and depression disorders or exacerbation of existing conditions. MBCT-R follows the MBCT structure of eight classes and one half-day retreat, with home practice and specific daily meditation, but is live-online and focuses on specific stressors (COVID-19, its economic and social consequences). Classes of 40-50 participants are led by 2 co-leaders. Participants have CHA MindWell Monitoring and telephone support during weeks 1-8 and then every 4 weeks afterwards for 24 weeks. Participants with severe symptoms or worsening moderate symptoms will be asked if they would like a mental wellness assessment with a clinician. If monitoring with CAT-MH interviews suggests symptomatic worsening, then a CHA MindWell technician will contact the participant and check-in and offer support, including setting up a televisit with a member of a clinical member of the outpatient mental health team if needed.
Cambridge Health Alliance
Cambridge, Massachusetts, 02141, United States
Rosansky JA, Okst K, Tepper MC, Baumgart Schreck A, Fulwiler C, Wang PS, Schuman-Olivier Z. Participants' Engagement With and Results From a Web-Based Integrative Population Mental Wellness Program (CHAMindWell) During the COVID-19 Pandemic: Program Evaluation Study. JMIR Ment Health. 2023 Oct 26;10:e48112. doi: 10.2196/48112.
Zev Schuman-Olivier, MD
Cambridge Health Alliance
Carl Fulwiler, MD
Cambridge Health Alliance
113 participants (actual enrollment reported by the registry).
First Submitted
October 19, 2020
First Posted
October 20, 2020
Study Start
March 15, 2021
Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program
Televisits (AKA Mental Wellness Assessments)
Randomization through Week 24
Positive and Negative Affect Reactivity Scales
Weeks -4, -3, -2, -1, 0, 9, 10, 11
Daily Inventory of Stressful Events
Weeks -4, -3, -2, -1, 9, 10, 11, 12
Inflammatory Cytokines (IL-6, IL-1b, IL-8, TNF-a)
Weeks -4, -3, -2, -1, 9, 10, 11, 12
Participants randomized to the CHA-MW arm will only receive CHAMindWell mental wellness monitoring with CAT-MH and telephone coaching as needed.
MoodGYM is based on CBT and interpersonal therapy targeting depression, anxiety, stress, and general psychological distress. MoodGYM has 6 sessions with five curriculum modules and a review session that can be completed within an 8-week period. iCBT participants will also be enrolled in CHA MindWell Monitoring and Support (CHA-MW). Participants across arms will have CHA MindWell Monitoring and Technician telephone support during weeks 1-8 and then every 4 weeks afterwards for 24 weeks. Participants with severe symptoms or worsening moderate symptoms will be asked if they would like a mental wellness assessment with a clinician. If there are difficulties with accessing iCBT technology or if monitoring with CAT-MH or CAT-DI/ANX-CAT interviews suggests symptomatic worsening, then a CHA MindWell technician will contact the participant and check-in and offer support, including setting up a televisit with a member of a clinical member of the outpatient mental health team if needed.
Participants across arms will have CHA MindWell Monitoring and Technician support during weeks 1-8 and then every 4 weeks afterwards for 24 weeks. Participants across arms will have CHA MindWell Monitoring and Technician telephone support during weeks 1-8 and then every 4 weeks afterwards for 24 weeks. Participants with severe symptoms or worsening moderate symptoms will be asked if they would like a mental wellness assessment with a clinician. If monitoring with CAT-MH or CAT-DI/ANX-CAT interviews suggests symptomatic worsening, then a CHA MindWell technician will contact the participant and check-in and offer support, including setting up a televisit with a member of a clinical member of the outpatient mental health team if needed.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 6, 2023
Actual (reported)Study Completion
March 6, 2023
Actual (reported)Last Updated
April 7, 2026
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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