Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy

Phase 4

Completed

• Conditions: Depression
• Interventions: Behavioral: Mindfulness based cognitive therapy (MBCT); Drug: Antidepressants; Drug: Placebo plus clinical management

• Registration Number: NCT00183560
• Lead Sponsor: Centre for Addiction and Mental Health

Brief 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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-30
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Mindfulness based cognitive therapy (MBCT)	Participants will receive mindfulness based cognitive therapy
2	Antidepressants	Participants will receive maintenance antidepressant pharmacotherapy
3	Placebo plus clinical management	Participants will receive placebo plus clinical management

Primary Outcome Measures

Name	Time	Method
Relapse of depression	Measured at Month 18

Trial Locations

Locations (2)

St. Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada