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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH066992 | U.S. NIH Grant/Contract | View source | |
| DSIR 83-ATP |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will determine the effectiveness of mindfulness-based cognitive therapy (MBCT) in preventing depression relapse.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive mindfulness based cognitive therapy |
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| 2 | Active Comparator | Participants will receive maintenance antidepressant pharmacotherapy |
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| 3 | Placebo Comparator | Participants will receive placebo plus clinical management |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness based cognitive therapy (MBCT) | Behavioral | Following antidepressant discontinuation, participants receive MBCT, an 8-week group program that integrates aspects of cognitive therapy and mindfulness meditation. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse of depression | Measured at Month 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zindel V. Segal, PhD | Center for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare | Hamilton | Ontario | L8N 3K7 | Canada | ||
| Centre for Addiction and Mental Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10965637 | Background | 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. | |
| 14756612 | Background | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Antidepressants | Drug | Participants continue on dosage of the antidepressant that was used to achieve clinical remission. |
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| Placebo plus clinical management | Drug | Following discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen. |
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| Toronto |
| Ontario |
| M5T 1R8 |
| Canada |
| 11952186 | Background | 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. |
| 14607387 | Background | 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. |
| 21135325 | Background | 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. |
| 22409641 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004191 |
| Behavioral Disciplines and Activities |
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |