- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02472483
Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response (TCC-MBCT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75014
- Centre hospitalier Sainte Anne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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 |
20-weeks CBT
8-weeks MBCT
|
Experimental: anxious disorders
Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT |
20-weeks CBT
8-weeks MBCT
|
Experimental: alcohol disorder
Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT |
20-weeks CBT
8-weeks MBCT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of relapses (for bipolar disorders)
Time Frame: 22-months
|
Number of relapses during 22-month
|
22-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of hospitalizations (for bipolar disorders)
Time Frame: 22-months
|
Number of hospitalizations during 22-months
|
22-months
|
Number of days in an episode (for bipolar disorders)
Time Frame: 22-months
|
Number of days in an episode during 22-months
|
22-months
|
Anxious symptomatology
Time Frame: 22-month
|
Improvement of manic, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)
|
22-month
|
Maniac symptomatology
Time Frame: 22-month
|
Improvement of maniac, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)
|
22-month
|
Depressive symptomatology
Time Frame: 22-month
|
Improvement of maniac, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)
|
22-month
|
Genetic polymorphisms
Time Frame: D0 (Inclusion)
|
D0 (Inclusion)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip GORWOOD, MD., PhD, Centre Hospitalier Sainte-Anne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D470
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Dependence
-
University Hospital, LilleCompleted
-
Tel-Aviv Sourasky Medical CenterMinistry of Health, IsraelUnknownAlcohol-dependenceIsrael
-
Pop Test Oncology LLCBaylor College of Medicine; Michael E. DeBakey VA Medical Center; Congressionally... and other collaboratorsCompletedPotential Treatment for Alcohol Dependence-Alcohol InteractionUnited States
-
DynamiCare HealthNational Institute on Alcohol Abuse and Alcoholism (NIAAA); RANDActive, not recruitingAlcohol Dependence | Alcohol Use Disorder | Drug DependenceUnited States
-
National Institute on Alcohol Abuse and Alcoholism...CompletedAlcohol Abuse | Alcohol Dependence (Primary Condition)United States
-
University Hospital, Gentofte, CopenhagenCompleted
-
Massachusetts General HospitalCompletedAlcohol Dependence | Drug Abuse | Alcohol Abuse | Drug DependenceUnited States
-
Psychiatric Centre RigshospitaletThe Novavì outpatient clinics, CopenhagenRecruitingAddiction, Alcohol | Alcohol Dependence, in RemissionDenmark
-
Psychiatric Centre RigshospitaletThe Novavì outpatient clinics, CopenhagenRecruitingAddiction, Alcohol | Alcohol Dependence, in RemissionDenmark
-
University of WashingtonU.S. Army Medical Research and Development CommandCompletedAlcohol Dependence | Substance Abuse | Alcohol Abuse | Substance DependenceUnited States
Clinical Trials on Cognitive and Behavior Therapy (CBT)
-
Baylor College of MedicineSouth Central VA Mental Illness Research, Education & Clinical CenterCompletedDepression | AnxietyUnited States
-
Karolinska InstitutetUppsala UniversityCompleted
-
Ohio State University Comprehensive Cancer CenterCompletedMajor Depressive DisorderUnited States
-
Mayo ClinicRecruitingMalignant Solid Neoplasm | Hematopoietic and Lymphoid System NeoplasmUnited States
-
Baylor College of MedicineRetirement Research Foundation; Archstone FoundationCompletedGeneralized Anxiety Disorder | Anxiety Disorder NOSUnited States
-
St. Jude Children's Research HospitalNational Cancer Institute (NCI); National Institutes of Health (NIH)RecruitingBone SarcomaUnited States
-
University of UtahCompletedSedentary Lifestyle | Stage IV Prostate Cancer AJCC v7 | Stage III Prostate Cancer AJCC v7United States
-
Karolinska InstitutetRegion StockholmCompletedPanic DisorderSweden
-
Vanderbilt UniversityNational Institute of Mental Health (NIMH)Completed
-
Baylor College of MedicineNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety DisorderUnited States