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

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.

Study Overview

• Status: Terminated
• Conditions: Alcohol Dependence; Bipolar Disorder; Anxious Disorder
• Intervention / Treatment: Behavioral: Cognitive and Behavior Therapy (CBT); Behavioral: Mindfulness Based Cognitive Therapy (MBCT)

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 Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Centre Hospitalier Sainte Anne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Investigators: Principal Investigator: Philip GORWOOD, MD., PhD, Centre Hospitalier Sainte-Anne

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2012
• Primary Completion (Actual): September 13, 2019
• Study Completion (Actual): September 13, 2019

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (Estimate): June 16, 2015

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Bipolar and Related Disorders; Alcoholism; Disease; Bipolar Disorder
• Other Study ID Numbers: D470