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NCT01145872 · ClinicalTrials.gov registry record · Phase 3
The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (MBCT) on Depressive Symptoms and Depression Relapse
A Phase 3 study, sponsored by University of Denver.
- Completed
- Registry status
- Phase 3
- Development phase
- 92
- Enrollment target
NCT01145872 is a Phase 3 study that has completed, run by University of Denver. The registered enrollment target is 92 participants.
The verdict
NCT01145872, a Phase 3 study, has completed, sponsored by University of Denver.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 92 participants
- Enrollment target
Study Summary
This research proposal is intended to elucidate the efficacy and mechanisms underlying Mindfulness Based Cognitive Therapy (MBCT) in a population in remission from recurrent Major Depressive Disorder (MDD). The first objective of the study is to replicate previous studies' findings of MBCT's effects on decreasing depressive symptoms and depression relapse rates. However, this proposal aims to make a novel contribution to the literature by using a randomized, controlled design, and comparing the effects of MBCT to an active control condition (ACC). The use of a well-designed ACC will enable us to control for confounding variables such as social support and expected outcomes, thus allowing us to determine whether elements specific to MBCT lead to its salutary effects (Aim 1). Previous MBCT studies have largely relied on self-report measurement methodologies, limiting valid conclusions about the nature of MBCT. Further, few studies have examined the mechanisms underlying effects of MBCT on depressive symptoms and relapse. Theoretical considerations and preliminary empirical evidence suggest emotional, physiological, and cognitive functioning to be promising mechanisms of MBCT. Therefore, the investigators propose to assess each of these potential mechanisms of MBCT using self-report, autonomic physiological, and reaction time tasks (Aim 2). Collectively, these aims are expected to strengthen the evidence base for MBCT while cultivating a scientific model for its effects and mechanisms on decreasing depressive symptoms and depression relapse rates.
Interventions
- BEHAVIORAL Mindfulness Based Cognitive Therapy
- BEHAVIORAL Health Enhancement Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01145872
The ClinicalTrials.gov registry entry for NCT01145872 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Denver, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mindfulness Based Cognitive Therapy is the first listed.
NCT01145872 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01145872 about?
NCT01145872 is a clinical study titled "The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (MBCT) on Depressive Symptoms and Depression Relapse". This research proposal is intended to elucidate the efficacy and mechanisms underlying Mindfulness Based Cognitive Therapy (MBCT) in a population in remission from recurrent Major Depressive Disorder (MDD). The first objective of the study is to replicate previous studies' findings of MBCT's effects...
What is the current status of trial NCT01145872?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 92 participants. The study started on 2010-07. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01145872?
The interventions under investigation include: Mindfulness Based Cognitive Therapy (BEHAVIORAL), Health Enhancement Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT01145872?
This trial is sponsored by University of Denver, which has 13 total clinical trials registered on ClinicalTrials.gov.
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