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

Sponsor

University of Denver (Other)

Overall Status

Completed

CT.gov ID

NCT01145872

Collaborator

Stanford University (Other), University of Colorado, Boulder (Other)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Recurrent	Behavioral: Mindfulness Based Cognitive Therapy Behavioral: Health Enhancement Program	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Effects and Mechanisms of MBCT on Depressive Symptoms and Depression Relapse

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness Based Cognitive Therapy	Behavioral: Mindfulness Based Cognitive Therapy
Active Comparator: Health Enhancement Program	Behavioral: Health Enhancement Program

Arm

Intervention/Treatment

Experimental: Mindfulness Based Cognitive Therapy

Behavioral: Mindfulness Based Cognitive Therapy

Active Comparator: Health Enhancement Program

Behavioral: Health Enhancement Program

Outcome Measures

Primary Outcome Measures

Depression Relapse [1 year]

Secondary Outcome Measures

Depressive Symptoms [1 Year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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