Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy
Prevention of Relapse in Recurrent Depression With MBCT
2 other identifiers
interventional
184
1 country
2
Brief Summary
This study will determine the effectiveness of mindfulness-based cognitive therapy (MBCT) in preventing depression relapse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 depression
Started Jul 2004
Longer than P75 for phase_4 depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJuly 1, 2015
June 1, 2015
6.3 years
September 13, 2005
June 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse of depression
Measured at Month 18
Study Arms (3)
1
EXPERIMENTALParticipants will receive mindfulness based cognitive therapy
2
ACTIVE COMPARATORParticipants will receive maintenance antidepressant pharmacotherapy
3
PLACEBO COMPARATORParticipants will receive placebo plus clinical management
Interventions
Following antidepressant discontinuation, participants receive MBCT, an 8-week group program that integrates aspects of cognitive therapy and mindfulness meditation.
Participants continue on dosage of the antidepressant that was used to achieve clinical remission.
Following discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
St. Joseph's Healthcare
Hamilton, Ontario, L8N 3K7, Canada
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8, Canada
Related Publications (6)
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.
PMID: 10965637BACKGROUNDMa 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.
PMID: 14756612BACKGROUNDTeasdale 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.
PMID: 11952186BACKGROUNDSegal 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.
PMID: 14607387BACKGROUNDSegal 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.
PMID: 21135325BACKGROUNDBieling 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.
PMID: 22409641BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zindel V. Segal, PhD
Center for Addiction and Mental Health
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Psychologist / Senior Scientist
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
July 1, 2004
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
July 1, 2015
Record last verified: 2015-06