NCT02472483

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

7 years

First QC Date

February 27, 2015

Last Update Submit

October 30, 2019

Conditions

Bipolar DisorderAnxious DisorderAlcohol Dependence

Outcome Measures

Primary Outcomes (1)

  • Number of relapses (for bipolar disorders)

    Number of relapses during 22-month

    22-months

Secondary Outcomes (6)

  • Number of hospitalizations (for bipolar disorders)

    22-months

  • Number of days in an episode (for bipolar disorders)

    22-months

  • Anxious symptomatology

    22-month

  • Maniac symptomatology

    22-month

  • Depressive symptomatology

    22-month

  • +1 more secondary outcomes

Study Arms (3)

bipolar disorder

EXPERIMENTAL

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

Behavioral: Cognitive and Behavior Therapy (CBT)Behavioral: Mindfulness Based Cognitive Therapy (MBCT)

anxious disorders

EXPERIMENTAL

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

Behavioral: Cognitive and Behavior Therapy (CBT)Behavioral: Mindfulness Based Cognitive Therapy (MBCT)

alcohol disorder

EXPERIMENTAL

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

Behavioral: Cognitive and Behavior Therapy (CBT)Behavioral: Mindfulness Based Cognitive Therapy (MBCT)

Interventions

Cognitive and Behavior Therapy (CBT)BEHAVIORAL

20-weeks CBT

alcohol disorderanxious disordersbipolar disorder
Mindfulness Based Cognitive Therapy (MBCT)BEHAVIORAL

8-weeks MBCT

alcohol disorderanxious disordersbipolar disorder

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-65 years
  • Men and women
  • Addressed to the CBT unit of the Clinique des Maladies Mentales et de l'EncĂ©phale - 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sainte Anne

Paris, 75014, France

Location

MeSH Terms

Conditions

Bipolar DisorderAlcoholism

Interventions

Cognitive Behavioral TherapyMindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMindfulness

Study Officials

  • Philip GORWOOD, MD., PhD

    Centre Hospitalier Sainte-Anne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2015

First Posted

June 16, 2015

Study Start

September 13, 2012

Primary Completion

September 13, 2019

Study Completion

September 13, 2019

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

FR(1)