Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy
|ClinicalTrials.gov Identifier: NCT00183560|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Mindfulness based cognitive therapy (MBCT) Drug: Antidepressants Drug: Placebo plus clinical management||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prevention of Relapse in Recurrent Depression With MBCT|
|Study Start Date :||July 2004|
|Primary Completion Date :||October 2010|
|Study Completion Date :||October 2010|
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
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
- Relapse of depression [ Time Frame: Measured at Month 18 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183560
|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|