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Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness based cognitive therapy (MBCT)
Antidepressants
Placebo plus clinical management
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Depression Recurrence, Drug Therapy, Cognitive Therapy, Relapse, Antidepressants

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare
  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Participants will receive mindfulness based cognitive therapy

Participants will receive maintenance antidepressant pharmacotherapy

Participants will receive placebo plus clinical management

Outcomes

Primary Outcome Measures

Relapse of depression

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
June 30, 2015
Sponsor
Centre for Addiction and Mental Health
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00183560
Brief Title
Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy
Official Title
Prevention of Relapse in Recurrent Depression With MBCT
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression Recurrence, Drug Therapy, Cognitive Therapy, Relapse, Antidepressants

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive mindfulness based cognitive therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive maintenance antidepressant pharmacotherapy
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo plus clinical management
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based cognitive therapy (MBCT)
Other Intervention Name(s)
MBCT
Intervention Description
Following antidepressant discontinuation, participants receive MBCT, an 8-week group program that integrates aspects of cognitive therapy and mindfulness meditation.
Intervention Type
Drug
Intervention Name(s)
Antidepressants
Other Intervention Name(s)
Antidepressant medication
Intervention Description
Participants continue on dosage of the antidepressant that was used to achieve clinical remission.
Intervention Type
Drug
Intervention Name(s)
Placebo plus clinical management
Other Intervention Name(s)
Placebo and Clinical Management
Intervention Description
Following discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen.
Primary Outcome Measure Information:
Title
Relapse of depression
Time Frame
Measured at Month 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zindel V. Segal, PhD
Organizational Affiliation
Center for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3K7
Country
Canada
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
10965637
Citation
Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.
Results Reference
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PubMed Identifier
14756612
Citation
Ma SH, Teasdale JD. Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psychol. 2004 Feb;72(1):31-40. doi: 10.1037/0022-006X.72.1.31.
Results Reference
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PubMed Identifier
11952186
Citation
Teasdale JD, Moore RG, Hayhurst H, Pope M, Williams S, Segal ZV. Metacognitive awareness and prevention of relapse in depression: empirical evidence. J Consult Clin Psychol. 2002 Apr;70(2):275-87. doi: 10.1037//0022-006x.70.2.275.
Results Reference
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PubMed Identifier
14607387
Citation
Segal ZV, Pearson JL, Thase ME. Challenges in preventing relapse in major depression. Report of a National Institute of Mental Health Workshop on state of the science of relapse prevention in major depression. J Affect Disord. 2003 Nov;77(2):97-108. doi: 10.1016/s0165-0327(02)00112-x.
Results Reference
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PubMed Identifier
21135325
Citation
Segal ZV, Bieling P, Young T, MacQueen G, Cooke R, Martin L, Bloch R, Levitan RD. Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. Arch Gen Psychiatry. 2010 Dec;67(12):1256-64. doi: 10.1001/archgenpsychiatry.2010.168.
Results Reference
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PubMed Identifier
22409641
Citation
Bieling PJ, Hawley LL, Bloch RT, Corcoran KM, Levitan RD, Young LT, Macqueen GM, Segal ZV. Treatment-specific changes in decentering following mindfulness-based cognitive therapy versus antidepressant medication or placebo for prevention of depressive relapse. J Consult Clin Psychol. 2012 Jun;80(3):365-72. doi: 10.1037/a0027483. Epub 2012 Mar 12.
Results Reference
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Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy

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