Clinical trial NCT02472483: Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response
Official title: Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bipolar Disorder
Anxious Disorder
Alcohol Dependence
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of relapses (for bipolar disorders)
timeFrame: 22-months
Secondary outcomes:
measure: Number of hospitalizations (for bipolar disorders)
timeFrame: 22-months
measure: Number of days in an episode (for bipolar disorders)
timeFrame: 22-months
measure: Anxious symptomatology
timeFrame: 22-month
measure: Maniac symptomatology
timeFrame: 22-month
measure: Depressive symptomatology
timeFrame: 22-month
measure: Genetic polymorphisms
timeFrame: D0 (Inclusion)
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier Sainte Anne
Study officials:
affiliation: Centre Hospitalier Sainte-Anne
name: Philip GORWOOD, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: