Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2010-10-31

Brief Summary

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This study will determine the effectiveness of mindfulness-based cognitive therapy (MBCT) in preventing depression relapse.

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Detailed Description

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Depression is a serious condition that can cause significant social and emotional problems and reduce the overall quality of life. Relapses in depressive episodes are common and may result in a patient's reluctance to follow a treatment regimen, thus making the episode more severe. Safe and effective therapies to prevent depression relapse are needed. This study will compare three different approaches to determine which is most effective in preventing relapses in depressive episodes.

This study will comprise 2 parts. In Part 1, all participants will receive antidepressant medication for 6 months. Participants whose depression symptoms do not improve will complete their study participation at the end of Part 1. Participants who respond to their regimen will be enrolled in Part 2. This part will last 18 months. During Part 2, participants will be randomly assigned to one of three groups. Participants in Group 1 will continue the drug regimen they began in Part 1. Participants in Group 2 will discontinue their antidepressants and attend an 8-week relapse prevention program. This MBCT program is designed to help participants learn skills that can increase their awareness and change their reaction to stressful events. Participants in Group 3 will have their antidepressant medication from Phase 1 switched to a placebo without their knowledge. Self-report scales will be used to assess the depressive symptoms of participants at the beginning of the study, at the end of Phase 1, and at the end of the study, after Phase 2.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Participants will receive mindfulness based cognitive therapy

Group Type EXPERIMENTAL

Mindfulness based cognitive therapy (MBCT)

Intervention Type BEHAVIORAL

Following antidepressant discontinuation, participants receive MBCT, an 8-week group program that integrates aspects of cognitive therapy and mindfulness meditation.

2

Participants will receive maintenance antidepressant pharmacotherapy

Group Type ACTIVE_COMPARATOR

Antidepressants

Intervention Type DRUG

Participants continue on dosage of the antidepressant that was used to achieve clinical remission.

3

Participants will receive placebo plus clinical management

Group Type PLACEBO_COMPARATOR

Placebo plus clinical management

Intervention Type DRUG

Following discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen.

Interventions

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Mindfulness based cognitive therapy (MBCT)

Following antidepressant discontinuation, participants receive MBCT, an 8-week group program that integrates aspects of cognitive therapy and mindfulness meditation.

Intervention Type BEHAVIORAL

Antidepressants

Participants continue on dosage of the antidepressant that was used to achieve clinical remission.

Intervention Type DRUG

Placebo plus clinical management

Following discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen.

Intervention Type DRUG

Other Intervention Names

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MBCT Antidepressant medication Placebo and Clinical Management

Eligibility Criteria

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Inclusion Criteria

* Meet DSM criteria for recurrent major depressive disorder, defined as at least one major depressive episode within 3 years prior to study entry AND at least 2 months of normal functioning following the episode

Exclusion Criteria

* Depression secondary to a concurrent medical disorder
* Current use of medication that could cause depressive symptoms
* A rating of level 2 or higher on the Index of Treatment Refractory Depression
* Current diagnosis of any of the following psychiatric disorders: psychotic or organic mental, bipolar, primary obsessive compulsive, borderline personality, antisocial personality, or eating
* Current diagnosis of comorbid chronic depression that is disabling
* Current substance abuse
* Score less than 14 on the Hamilton Rating Scale for Depression-17 (HRSD-17)
* At risk for suicide
* Pregnancy or plan to become pregnant during the study
* Practice meditation more than once a week or yoga more than twice a week at study entry

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No