The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (MBCT) on Depressive Symptoms and Depression Relapse

NCT01145872 | Completed Phase 3 DMC

• 1 other identifier: F32AT004879-01A2
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder; Recurrent

Keywords

Mindfulness; clinical trial; intervention; prevention

Outcome Measures

Primary Outcomes (1)

• Depression Relapse

  1 year

Secondary Outcomes (1)

• Depressive Symptoms

  1 Year

Study Arms (2)

Mindfulness Based Cognitive Therapy

EXPERIMENTAL

Behavioral: Mindfulness Based Cognitive Therapy

Health Enhancement Program

ACTIVE COMPARATOR

Behavioral: Health Enhancement Program

Interventions

Mindfulness Based Cognitive Therapy BEHAVIORAL

Mindfulness Based Cognitive Therapy

Health Enhancement Program BEHAVIORAL

Health Enhancement Program

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• must comprehend English well
• be 18-55 years of age
• meet enhanced DSM-IV criteria for remission of MDD, recurrent and have a history of three or more previous episodes of DSM-IV major depression in the absence of a history of mania or hypomania
• at least one of those episodes was within the past two years
• participant must be in remission and if on antidepressant medication (ADM), they must be on a stable dose with no change in type or amount for past 12 weeks or participants must be off ADM at T1 for at least the preceding 12 weeks
• have, at screening assessment, residual depressive symptoms indicated by a Beck Depression Inventory-II (BDI-II;\[72\]) score between 6-19.

You may not qualify if:

• bipolar disorder
• schizophrenia or borderline personality disorder
• current suicidal thoughts and/or suicide attempt in last two months
• current anxiety disorder if it constitutes the predominant aspect of the clinical presentation and requires primary treatment not offered in the project
• substance abuse or dependence within last three months
• dementia or subnormal intellectual potential
• current obsessive-compulsive disorder
• current eating disorder
• history of previous mindfulness training or more than eight lifetime sessions of CBT
• current use of psychotherapy or counseling

Sponsors & Collaborators

• University of Denver: lead
• Stanford University: collaborator
• University of Colorado, Boulder: collaborator

Study Sites (1)

University of Denver

Denver, Colorado, 80208, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Doctoral Researcher

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 17, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: April 1, 2013
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)