| ID | Type | Description | Link |
|---|---|---|---|
| R01AT004572-01A1 | U.S. NIH Grant/Contract | View source | |
| 3063975 |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This study is a randomized, controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) versus Health-Enhancement Program (HEP) for patients with treatment-resistant major depressive disorder (MDD). Both arms of the study will continue to receive the standard medication management treatment as usual (TAU) throughout the study. MBCT is a new technique that has been found to be effective for prevention of relapse in individuals in complete recovery from depression. MBCT is a group-based, 8-week intervention that uses mindfulness meditation as its core therapeutic ingredient. It teaches people to have a different relationship to depressive thoughts and feelings. This study will use an active condition called the Health Enhancement Program (HEP) which was specifically developed to serve as a comparison condition for mindfulness interventions. HEP has been shown to decrease global stress levels and to increase perceived health. Stress has been considered a contributor to depression. One hundred and seventy four patients with MDD who have failed two or more adequate antidepressant trials will be identified and randomly assigned to one of two groups: MBCT+TAU or HEP+TAU. All patients who enroll in the study will undergo follow-up assessments at 3, 6, 9 and 12 months following the intervention. A supplemental portion of the study will enroll 88 patients to undergo functional magnetic resonance imagining (fMRI) scans immediately before and after treatment to better understand the neural pathways implicated in depression and those that may be affected through treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Mindfulness Based Cognitive Therapy (MBCT) + medication management |
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| 2 | Active Comparator | The Health Enhancement Program (HEP) + medication management |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Cognitive Therapy | Behavioral | Mindfulness-Based Cognitive Therapy (MBCT) is a group treatment that integrates mindfulness meditation training with some CBT concepts and was specifically developed as a relapse prevention intervention for MDD. The program teaches skills that allow patients to disengage from habitual ("automatic") dysfunctional cognitive routines, in particular depression-related ruminative thought patterns, as a way to reduce future risk of relapse and recurrence of depression. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HAMD-17) | Baseline, 4, 8, 24, 36, 52 week |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depressive Symptomatology(Self-Rated)-16 items(QIDS-SR16) | Baseline, weeks 1-8, 24, 36, 52 week | |
| Short Form Health Survey-36 | Baseline, 8, 24, 36, 52 week | |
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Inclusion Criteria:
DSM-IV TR Diagnosis of Major Depression receiving medication management.
Adequate trial of 2 or more antidepressants (ATHF) for a minimum of 6 weeks (one of which at UCSF).
Hamilton Depression Rating Scale 17 score ≥ 14
Any Ethnicity
English Speaking
Male or Female
No current psychotherapy (i.e. only medication management treatment) or plan to start new psychotherapy during MBCT or HEP
Exclusion Criteria:
Bipolar Disorder, Obsessive Compulsive Disorder, Schizophrenia, Schizoaffective Disorder, Antisocial and Borderline Personality Disorders, Current Eating Disorder, Pervasive Development Delay Major Depression with Psychotic Features
Active Suicidality (per HAM-D17 > 1 on item 3)
Meditation Practice once or more per week; yoga more than twice per week at study entry
Substance Abuse Disorder within 6 months
Cognitive Disorder with Mini Mental Status Exam score < 25
Medical illness rated 4 on Cumulative Illness Rating Scale
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| Name | Affiliation | Role |
|---|---|---|
| Stuart J Eisendrath, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14399272 | Background | HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available. | |
| 12562566 | Background | Rush AJ, Trivedi M, Fava M. Depression, IV: STAR*D treatment trial for depression. Am J Psychiatry. 2003 Feb;160(2):237. doi: 10.1176/appi.ajp.160.2.237. No abstract available. |
| Label | URL |
|---|---|
| UCSF Depression Center | View source |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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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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| Health Enhancement Program and medication management | Behavioral | The Health Enhancement Program (HEP)was developed at the University of Wisconsin, Madison and is modeled after traditional activity and nutrition programs used in weight management- cardiac rehab and diabetes prevention programs. The program is designed to increase overall health and well-being by focusing on four health domains that impact health and are interventions regularly practiced at integrative medicine. These include: (I) Music Therapy (2) Nutrition (3) physical activity including, walking and stretching and (4) Functional movement. |
|
| Clinical Global Improvement Scale (CGI) |
| Baseline, 8, 24, 36, 52 weeks |
| Work and Social Activity Scale (WSAS) | Baseline, 8, 24,36,52 weeks |
| Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF) | Baseline, 8, 24, 36, 52 weeks |
| 16554525 | Background | Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M; STAR*D Study Team. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med. 2006 Mar 23;354(12):1231-42. doi: 10.1056/NEJMoa052963. |
| 8628042 | Background | Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. |
| 11983645 | Background | Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461. |
| 8290681 | Background | Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6. |
| 24612825 | Derived | Eisendrath SJ, Gillung EP, Delucchi KL, Chartier M, Mathalon DH, Sullivan JC, Segal ZV, Feldman MD. Mindfulness-based cognitive therapy (MBCT) versus the health-enhancement program (HEP) for adults with treatment-resistant depression: a randomized control trial study protocol. BMC Complement Altern Med. 2014 Mar 11;14:95. doi: 10.1186/1472-6882-14-95. |
| D004191 |
| Behavioral Disciplines and Activities |