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The primary aim of this study is to test the feasibility and efficacy of Mindfulness Based Cognitive Therapy (MBCT) training for the treatment of depressive symptoms in patients with chronic pain. The study also aims to elucidate the mechanisms underlying MBCT on a psychological and neurobiological level. For this purpose the study subjects will fill out several psychological questionnaires related to mindfulness, depression and chronic pain. Moreover this study involves optional fMRI scans of the brain and blood measures before and after the intervention.
Main hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment As Usual + Mindfulness Based Cognitive Therapy | Experimental | Subjects randomized into the intervention group will receive, a manualized 8-week MBCT group skills program with sessions that each last 2 hours, in addition to their treatment as usual (TAU). |
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| Treatment As Usual | No Intervention | Patients randomized into the TAU group will continue to receive their care as usual and be put on a waitlist. They will be offered the MBCT treatment after the completion of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Cognitive Therapy | Behavioral | A manualized 8-week MBCT group skills program with weekly sessions that each last 2 hours. The MBCT sessions combine elements of cognitive therapy with a mindful approach to thoughts and feelings, including a significant meditation component. The program is specifically tailored to a population that suffers from active depressive symptoms and chronic pain. The program also includes daily homework exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline on the combined Quick Inventory of Depressive Symptomatology-clinician rated and the Hamilton Rating Scale for Depression (QIDS-C16/HRDS17), at week 8. | week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Response according to the Beck Anxiety Inventory, 21 items (BAI). | Baseline, week 8, 6 months, 12 months | |
| Response according to Short Form Health Survey, 36 items (SF-36). | Baseline, week 8, 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Ashih, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Marasha De Jong, MD | Masachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Depression Clinical and Research Program | Boston | Massachusetts | 02114 | United States |
| 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. | |
| 21251756 | Background | Veehof MM, Oskam MJ, Schreurs KMG, Bohlmeijer ET. Acceptance-based interventions for the treatment of chronic pain: a systematic review and meta-analysis. Pain. 2011 Mar;152(3):533-542. doi: 10.1016/j.pain.2010.11.002. Epub 2011 Jan 19. |
| Label | URL |
|---|---|
| Depression Clinical and Research Program | View source |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019263 | Dysthymic Disorder |
| D003863 | Depression |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Response according to Brief Pain Inventory (BPI-sf). | Baseline, week 4, week 8, 6 months, 12 months |
| 28252881 | Derived | de Jong M, Peeters F, Gard T, Ashih H, Doorley J, Walker R, Rhoades L, Kulich RJ, Kueppenbender KD, Alpert JE, Hoge EA, Britton WB, Lazar SW, Fava M, Mischoulon D. A Randomized Controlled Pilot Study on Mindfulness-Based Cognitive Therapy for Unipolar Depression in Patients With Chronic Pain. J Clin Psychiatry. 2018 Jan/Feb;79(1):15m10160. doi: 10.4088/JCP.15m10160. |
| D001519 |
| Behavior |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 |
| Behavioral Disciplines and Activities |