Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy

June 30, 2015 updated by: Zindel Segal, Centre for Addiction and Mental Health

Prevention of Relapse in Recurrent Depression With MBCT

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3K7
        • St. Joseph's Healthcare
      • Toronto, Ontario, Canada, M5T 1R8
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive mindfulness based cognitive therapy
Behavioral: 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.
Other Names:
  • MBCT
Active Comparator: 2
Participants will receive maintenance antidepressant pharmacotherapy
Drug: Antidepressants
Participants continue on dosage of the antidepressant that was used to achieve clinical remission.
Other Names:
  • Antidepressant medication
Placebo Comparator: 3
Participants will receive placebo plus clinical management
Drug: Placebo plus clinical management
Following discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen.
Other Names:
  • Placebo and Clinical Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse of depression
Time Frame: Measured at Month 18
Measured at Month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Zindel V. Segal, PhD, Center for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH066992 (U.S. NIH Grant/Contract)
  • DSIR 83-ATP (NCT00719979)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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