Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Zindel Segal, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00183560
First received: September 13, 2005
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Depression
Behavioral: Mindfulness based cognitive therapy (MBCT)
Drug: Antidepressants
Drug: Placebo plus clinical management
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Relapse in Recurrent Depression With MBCT

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Relapse of depression [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]

Enrollment: 184
Study Start Date: July 2004
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Placebo and Clinical Management

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183560

Locations
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 3K7
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Zindel V. Segal, PhD Center for Addiction and Mental Health
  More Information

Publications:

Responsible Party: Zindel Segal, Psychologist / Senior Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00183560     History of Changes
Other Study ID Numbers: R01 MH66992, R01MH066992, DSIR 83-ATP
Study First Received: September 13, 2005
Last Updated: April 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Centre for Addiction and Mental Health:
Depression Recurrence
Drug Therapy
Cognitive Therapy
Relapse
Antidepressants

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014