Bipolar DisorderTCC-MBCTNCT02472483
Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response
A study testing Cognitive and Behavior Therapy (CBT) and Mindfulness Based Cognitive Therapy (MBCT) in people with Bipolar Disorder and Anxious Disorder, run by Centre Hospitalier St Anne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Anxious Disorder, Alcohol Dependence
- What is being tested?
- Cognitive and Behavior Therapy (CBT) and Mindfulness Based Cognitive Therapy (MBCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2012to 13 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bipolar Disorder, Anxious Disorder, Alcohol Dependence
- Being tested
- Cognitive and Behavior Therapy (CBT), Mindfulness Based Cognitive Therapy (MBCT)
- Medical subject headings
- Bipolar Disorder, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and Behavior Therapy (CBT)Behavioural
20-weeks CBT
Mindfulness Based Cognitive Therapy (MBCT)Behavioural
8-weeks MBCT
| Study group | Role | What they receive |
|---|---|---|
| bipolar disorder | Experimental | Cognitive and Behavior Therapy (CBT) : 20-weeks CBT
+ Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT Receives: 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 Receives: 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 Receives: Behavioral: Cognitive and Behavior Therapy (CBT); Behavioral: Mindfulness Based Cognitive Therapy (MBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of relapses (for bipolar disorders)
Number of relapses during 22-month
Measured: 22-months
Secondary outcomes (6)
Number of hospitalizations (for bipolar disorders)
Number of hospitalizations during 22-months
Measured: 22-months
Number of days in an episode (for bipolar disorders)
Number of days in an episode during 22-months
Measured: 22-months
Anxious symptomatology
Improvement of manic, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)
Measured: 22-month
Maniac symptomatology
Improvement of maniac, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)
Measured: 22-month
Depressive symptomatology
Improvement of maniac, depressive and/or anxious symptomatology during 22-month (scores MRS, HDRS, BDI,HARS, STAI)
Measured: 22-month
Genetic polymorphisms
Measured: D0 (Inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study start13 Sep 2012
- Primary completion13 Sep 2019
- Study completion13 Sep 2019
Why it stopped: Difficult for recruting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip GORWOOD, MD., PhD, Principal investigator, Centre Hospitalier Sainte-Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472483
- Sponsor's protocol ID
- D470
- Acronym
- TCC-MBCT
- Status last verified
- Oct 2019
- First submitted
- 27 Feb 2015
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response
- ClinicalTrials.gov ID
- NCT02472483
- Acronym / sponsor ID
- TCC-MBCT / D470
- Conditions
- Bipolar Disorder, Anxious Disorder, Alcohol Dependence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult for recruting
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 13 Sep 2012 (actual)
- Primary completion
- 13 Sep 2019 (actual)
- Study completion
- 13 Sep 2019 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bipolar disorder | Experimental | Behavioral: Cognitive and Behavior Therapy (CBT), Behavioral: Mindfulness Based Cognitive Therapy (MBCT)Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT |
| anxious disorders | Experimental | Behavioral: Cognitive and Behavior Therapy (CBT), Behavioral: Mindfulness Based Cognitive Therapy (MBCT)Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT |
| alcohol disorder | Experimental | Behavioral: Cognitive and Behavior Therapy (CBT), Behavioral: Mindfulness Based Cognitive Therapy (MBCT)Cognitive and Behavior Therapy (CBT) : 20-weeks CBT + Mindfulness Based Cognitive Therapy (MBCT) : 8-weeks MBCT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive and Behavior Therapy (CBT)20-weeks CBT | Behavioural | alcohol disorder, anxious disorders, bipolar disorder |
| Mindfulness Based Cognitive Therapy (MBCT)8-weeks MBCT | Behavioural | alcohol disorder, anxious disorders, bipolar disorder |
Primary outcome
Number of relapses (for bipolar disorders)
Time frame: 22-months
Number of relapses during 22-month
6 secondary outcomes
Number of hospitalizations (for bipolar disorders)
Time frame: 22-months
Number of days in an episode (for bipolar disorders)
Time frame: 22-months
Anxious symptomatology
Time frame: 22-month
Maniac symptomatology
Time frame: 22-month
Depressive symptomatology
Time frame: 22-month
Genetic polymorphisms
Time frame: D0 (Inclusion)
Results and safety
The study was stopped early (reason given: Difficult for recruting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip GORWOOD, MD., PhD principal investigator
Centre Hospitalier Sainte-Anne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive and Behavior Therapy (CBT) and Mindfulness Based Cognitive Therapy (MBCT) in people with Bipolar Disorder and Anxious Disorder, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficult for recruting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of relapses (for bipolar disorders) (time frame: 22-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.