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

Not Applicable

Terminated

• Conditions: Bipolar Disorder; Alcohol Dependence; Anxious Disorder
• Interventions: Behavioral: Cognitive and Behavior Therapy (CBT); Behavioral: Mindfulness Based Cognitive Therapy (MBCT)

• Registration Number: NCT02472483
• Lead Sponsor: Centre Hospitalier St Anne

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-09-13
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-16
• Primary Completion: 2019-09-13
• Study Completion: 2019-09-13
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anxious disorders	Mindfulness Based Cognitive Therapy (MBCT)	Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT
bipolar disorder	Cognitive and Behavior Therapy (CBT)	Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT
bipolar disorder	Mindfulness Based Cognitive Therapy (MBCT)	Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT
anxious disorders	Cognitive and Behavior Therapy (CBT)	Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT
alcohol disorder	Cognitive and Behavior Therapy (CBT)	Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT
alcohol disorder	Mindfulness Based Cognitive Therapy (MBCT)	Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT

Primary Outcome Measures

Name	Time	Method
Number of relapses (for bipolar disorders)	22-months	Number of relapses during 22-month

Secondary Outcome Measures

Name	Time	Method
Number of days in an episode (for bipolar disorders)	22-months	Number of days in an episode during 22-months
Anxious symptomatology	22-month	Improvement of manic, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)
Depressive symptomatology	22-month	Improvement of maniac, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)
Number of hospitalizations (for bipolar disorders)	22-months	Number of hospitalizations during 22-months
Maniac symptomatology	22-month	Improvement of maniac, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)
Genetic polymorphisms	D0 (Inclusion)

Trial Locations

Locations (1)

Centre Hospitalier Sainte Anne; 🇫🇷 Paris, France