Clinical Trials Directory

Trials / Completed

CompletedNCT00183560

Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy

Prevention of Relapse in Recurrent Depression With MBCT

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
184 (actual)
Sponsor
Centre for Addiction and Mental Health · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMindfulness based cognitive therapy (MBCT)Following antidepressant discontinuation, participants receive MBCT, an 8-week group program that integrates aspects of cognitive therapy and mindfulness meditation.
DRUGAntidepressantsParticipants continue on dosage of the antidepressant that was used to achieve clinical remission.
DRUGPlacebo plus clinical managementFollowing discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen.

Timeline

Start date
2004-07-01
Primary completion
2010-10-01
Completion
2010-10-01
First posted
2005-09-16
Last updated
2015-07-01

Locations

2 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT00183560. Inclusion in this directory is not an endorsement.