Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response

Conditions
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Bipolar Disorder, Anxious Disorder, Alcohol Dependence

Intervention / Treatment
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* Behavioral: Cognitive and Behavior Therapy (CBT)
* Behavioral: Mindfulness Based Cognitive Therapy (MBCT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-65 years Men and women Addressed to the CBT unit of the Clinique des Maladies Mentales et de l'Encéphale - CMME- (Sainte Anne Hospital) Having a bipolar I or II disorder (224 patients) or eating disorder (224 patients) : bulimia or discorder of use alcohol or gambling (224 patients) mood stabilizer treatment for more than six months, for bipolar patients Understanding and speaking French fluently Patient agreeing to participate and signing the consent form Exclusion Criteria: Age <18 or> 65 current manic, hypomanic, or depressive episode for bipolar patients Score on the Hamilton Depression Rating Scale - HDRS greater than or equal to 16 Score on the Mania Rating Scale - MRS higher or equal to 6 for bipolar patients Schizophrenic disorder Severe somatic pathology (cancer, heart, kidney or respiratory failure, central neurological disorder), scalable, or are likely to be life-threatening in a period of less than one year Refusal of a mood stabilizer treatment for bipolar patients Inability to respond to assessment (eg failure or deterioration of mental ability.) No affiliation to a social security scheme Private topics of liberty by judicial or administrative decision Pregnant women 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bipolar disorder<br>Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT | Behavioral: Cognitive and Behavior Therapy (CBT)<br>* 20-weeks CBT<br>Behavioral: Mindfulness Based Cognitive Therapy (MBCT)<br>* 8-weeks MBCT<br>|
| Experimental: anxious disorders<br>Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT | Behavioral: Cognitive and Behavior Therapy (CBT)<br>* 20-weeks CBT<br>Behavioral: Mindfulness Based Cognitive Therapy (MBCT)<br>* 8-weeks MBCT<br>|
| Experimental: alcohol disorder<br>Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT | Behavioral: Cognitive and Behavior Therapy (CBT)<br>* 20-weeks CBT<br>Behavioral: Mindfulness Based Cognitive Therapy (MBCT)<br>* 8-weeks MBCT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of relapses (for bipolar disorders) | Number of relapses during 22-month | 22-months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |