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NCT04595084 · ClinicalTrials.gov registry record · NA
Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use
A NA study, sponsored by Cambridge Health Alliance.
- Completed
- Registry status
- NA
- Development phase
- 113
- Enrollment target
NCT04595084: Completed NA study, sponsored by Cambridge Health Alliance.
NCT04595084 is a NA study that has completed, run by Cambridge Health Alliance. The registered enrollment target is 113 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04595084, a NA study, has completed, sponsored by Cambridge Health Alliance.
- COMPLETED
- Registry status
- NA
- Development phase
- 113 participants
- Enrollment target
Study Summary
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).
Primary Outcome
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.
Interventions
- BEHAVIORAL Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell
- BEHAVIORAL Internet Cognitive Behavioral Therapy plus CHAMindWell
- BEHAVIORAL CHAMindWell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2023-03-06 |
| Phase | NA |
What the finished NCT04595084 record still lists
NCT04595084 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell is the first listed.
NCT04595084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04595084 about?
NCT04595084 is a clinical study titled "Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use". 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 te...
What is the current status of trial NCT04595084?
This trial is currently completed. It is a NA study. The enrollment target is 113 participants. The study started on 2021-03-15. Estimated completion is 2023-03-06.
What interventions are being tested in trial NCT04595084?
The interventions under investigation include: Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell (BEHAVIORAL), Internet Cognitive Behavioral Therapy plus CHAMindWell (BEHAVIORAL), CHAMindWell (BEHAVIORAL).
Who is sponsoring clinical trial NCT04595084?
This trial is sponsored by Cambridge Health Alliance, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04595084's enrollment target sits among peer trials
113 813th of 2000 higher than 1,188 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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