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

Bipolar Disorder Clinical Trial

— TCC-MBCT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02472483
• Other study ID #: D470
• Status: Terminated
• Phase: N/A
• Start date: September 13, 2012
• Est. completion date: September 13, 2019

Study information

• Verified date: October 2019
• Source: Centre Hospitalier St Anne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 158
• Est. completion date: September 13, 2019
• Est. primary completion date: September 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Anxious Disorder
• Bipolar Disorder
• Disease

Intervention

Behavioral:
• Cognitive and Behavior Therapy (CBT)
20-weeks CBT
• Mindfulness Based Cognitive Therapy (MBCT)
8-weeks MBCT

Locations

Country	Name	City	State
France	Centre Hospitalier Sainte Anne	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of relapses (for bipolar disorders)	Number of relapses during 22-month	22-months
Secondary	Number of hospitalizations (for bipolar disorders)	Number of hospitalizations during 22-months	22-months
Secondary	Number of days in an episode (for bipolar disorders)	Number of days in an episode during 22-months	22-months
Secondary	Anxious symptomatology	Improvement of manic, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)	22-month
Secondary	Maniac symptomatology	Improvement of maniac, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)	22-month
Secondary	Depressive symptomatology	Improvement of maniac, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)	22-month
Secondary	Genetic polymorphisms		D0 (Inclusion)