Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy
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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 |
- 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 |
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| Canada, Ontario | |
| St. Joseph's Healthcare | |
| Hamilton, Ontario, Canada, L8N 3K7 | |
| Centre for Addiction and Mental Health | |
| Toronto, Ontario, Canada, M5T 1R8 | |
| 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 Mood Disorders Mental Disorders |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013