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Difficult for recruting
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The purpose of this study is to determine whether a Cognitive and Behavioral group Therapy (CBT) + Mindfulness Based Cognitive Therapy (MBCT) decreased relapses and hospitalizations and improved outcomes (depressive and manic symptoms, self-esteem, and quality of life) in a large sample of refractory bipolar I patients on mood stabilizers.
In recent years, various controlled studies showed that psychoeducational interventions have been effective in decreasing relapse and improving outcomes for bipolar disorders. However, samples were often small, compromising statistical power, and with a large variety of patients. The investigators therefore tested if a CBT group psychoeducation program + MBCT decreased relapses and improved outcomes in a large sample of refractory bipolar I patients on mood stabilizers. Patients were tested at recruitment, at 6-month follow-up CBT and at 2-month follow-up MBCT using clinical interviews and self-report questionnaires. The primary outcome measure of efficacy was relapse during the follow-up requiring either hospitalization, modification of treatment or HDRS ≥ 16 or MRS ≥ 6. The secondary outcome measure was symptomatic and functional improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bipolar disorder | Experimental | Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT |
|
| anxious disorders | Experimental | Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT |
|
| alcohol disorder | Experimental | Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive and Behavior Therapy (CBT) | Behavioral | 20-weeks CBT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of relapses (for bipolar disorders) | Number of relapses during 22-month | 22-months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hospitalizations (for bipolar disorders) | Number of hospitalizations during 22-months | 22-months |
| Number of days in an episode (for bipolar disorders) | Number of days in an episode during 22-months |
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Inclusion Criteria:
Exclusion Criteria:
For bipolar patients, the presence of rapid cycling, family history of bipolar disorder, comorbid Axis I and II disorders, protective measures (curatorship or guardianship) are not exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Philip GORWOOD, MD., PhD | Centre Hospitalier Sainte-Anne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sainte Anne | Paris | 75014 | France |
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| Mindfulness Based Cognitive Therapy (MBCT) | Behavioral | 8-weeks MBCT |
|
| 22-months |
| Anxious symptomatology | Improvement of manic, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI) | 22-month |
| Maniac symptomatology | Improvement of maniac, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI) | 22-month |
| Depressive symptomatology | Improvement of maniac, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI) | 22-month |
| Genetic polymorphisms | D0 (Inclusion) |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D064866 | Mindfulness |
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