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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-13

Study Completion Date

2019-09-13

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.

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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.

Conditions

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Bipolar Disorder Anxious Disorder Alcohol Dependence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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bipolar disorder

Cognitive and Behavior Therapy (CBT) : 20-weeks CBT

\+ Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT

Group Type EXPERIMENTAL

Cognitive and Behavior Therapy (CBT)

Intervention Type BEHAVIORAL

20-weeks CBT

Mindfulness Based Cognitive Therapy (MBCT)

Intervention Type BEHAVIORAL

8-weeks MBCT

anxious disorders

Cognitive and Behavior Therapy (CBT) : 20-weeks CBT

\+ Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT

Group Type EXPERIMENTAL

Cognitive and Behavior Therapy (CBT)

Intervention Type BEHAVIORAL

20-weeks CBT

Mindfulness Based Cognitive Therapy (MBCT)

Intervention Type BEHAVIORAL

8-weeks MBCT

alcohol disorder

Cognitive and Behavior Therapy (CBT) : 20-weeks CBT

\+ Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT

Group Type EXPERIMENTAL

Cognitive and Behavior Therapy (CBT)

Intervention Type BEHAVIORAL

20-weeks CBT

Mindfulness Based Cognitive Therapy (MBCT)

Intervention Type BEHAVIORAL

8-weeks MBCT

Interventions

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Cognitive and Behavior Therapy (CBT)

20-weeks CBT

Intervention Type BEHAVIORAL

Mindfulness Based Cognitive Therapy (MBCT)

8-weeks MBCT

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No