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

Primary Purpose

Bipolar Disorder, Anxious Disorder, Alcohol Dependence

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive and Behavior Therapy (CBT)
Mindfulness Based Cognitive Therapy (MBCT)
Sponsored by
Centre Hospitalier St Anne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Sainte Anne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

bipolar disorder

anxious disorders

alcohol disorder

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Number of relapses (for bipolar disorders)
Number of relapses during 22-month

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2015
Last Updated
October 30, 2019
Sponsor
Centre Hospitalier St Anne
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1. Study Identification

Unique Protocol Identification Number
NCT02472483
Brief Title
Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response
Acronym
TCC-MBCT
Official Title
Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficult for recruting
Study Start Date
September 13, 2012 (Actual)
Primary Completion Date
September 13, 2019 (Actual)
Study Completion Date
September 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Anxious Disorder, Alcohol Dependence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bipolar disorder
Arm Type
Experimental
Arm Description
Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT
Arm Title
anxious disorders
Arm Type
Experimental
Arm Description
Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT
Arm Title
alcohol disorder
Arm Type
Experimental
Arm Description
Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT
Intervention Type
Behavioral
Intervention Name(s)
Cognitive and Behavior Therapy (CBT)
Intervention Description
20-weeks CBT
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy (MBCT)
Intervention Description
8-weeks MBCT
Primary Outcome Measure Information:
Title
Number of relapses (for bipolar disorders)
Description
Number of relapses during 22-month
Time Frame
22-months
Secondary Outcome Measure Information:
Title
Number of hospitalizations (for bipolar disorders)
Description
Number of hospitalizations during 22-months
Time Frame
22-months
Title
Number of days in an episode (for bipolar disorders)
Description
Number of days in an episode during 22-months
Time Frame
22-months
Title
Anxious symptomatology
Description
Improvement of manic, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)
Time Frame
22-month
Title
Maniac symptomatology
Description
Improvement of maniac, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)
Time Frame
22-month
Title
Depressive symptomatology
Description
Improvement of maniac, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)
Time Frame
22-month
Title
Genetic polymorphisms
Time Frame
D0 (Inclusion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip GORWOOD, MD., PhD
Organizational Affiliation
Centre Hospitalier Sainte-Anne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Sainte Anne
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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

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