Bipolar DisorderNCT00999765
Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder
An observational study of Bipolar Disorder, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the feasibility and short-term efficacy of MBCT as an add-on (i.e. patients must be stable with their regular mood stabilizing medication) for the maintenance therapy of bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Mindfulness-Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Dec 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bipolar Disorder of third-line bipolar disorders program
Who may be able to join
- Males or females (>18 years old)
- Bipolar disorder (as per the Structured Clinical Interview for DSM Disorders (SCID)(22)), euthymic state: Complete remission for at least four weeks ((Montgomery and Asberg Rating Scale (MADRS) ≤ 6 and item-1 (depressed mood) = 0 and no suicidal ideations (MADRS(item-10) < 4)
- Must have had at least 3 depressive phases in the last 5 years
- Cooperative and willing to complete all the aspects of the study and especially the 45 minutes of exercise per day
- Must have completed a Secondary V (11th grade) education
Who cannot join
- Other active psychiatric disorders (as per the SCID)
- Rapid cycling
- Bipolar disorder secondary to a medical condition or substance-induced mood disorder
- Suicidal ideations (MADRS(item 10)>3)
- Active i.e. unstable and/or untreated medical condition
- Substance abuse (defined as per DSM-IV) in the last four weeks
Show all 13Show fewer
- CBT (No more than four sessions (ever))
- Previous participation in a psychoeducation group within the last 6 months
- Current other psychotherapy (more than once a month)
- Practice of meditation (more than once a month) during the last two years
- Practice of yoga (more than once a week) during the last year
- Previous participation in a MBSR group
- Electroconvulsive Therapy (ECT) within the last three months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
About this study
The purpose of this study is to evaluate the feasibility and short-term efficacy of MBCT as an add-on (i.e. patients must be stable with their regular mood stabilizing medication) for the maintenance therapy of bipolar disorder.
- Conditions
- Bipolar Disorder
- Being tested
- Mindfulness-Based Cognitive Therapy
- Keywords
- Bipolar Disorder, Bipolar Depression, Mindfulness-Based Cognitive Therapy, MBCT, Maintenance, Euthymic, Efficacy, Feasibility
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyBehavioural
eight-week (two hours a week) group therapy (8-12 patients per group)
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder - stable | Not described Receives: Behavioral: Mindfulness-Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of weeks in which criteria are meet for a mood episode evaluate with the Longitudinal Interval Follow-up Evaluation (LIFE)
Measured: 12 weeks (4 weeks post treatment)
Secondary outcomes (4)
Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale
Measured: 2, 4, 6, 8 and 12 weeks
Change in intensity of subsyndromal symptoms of depression on the MADRS scale
Measured: 2, 4, 6, 8 and 12 weeks
Change in intensity of subsyndromal symptoms of hypomania on the YMRS scale
Measured: 2, 4, 6, 8 and 12 weeks
Change id intensity in subsyndromal symptoms of anxiety on the HAM-A scale
Measured: 2,4,6,8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startJun 2008
- Primary completionMar 2010
- Study completionDec 2012
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serge Beaulieu, Douglas Mental Health University Institute
- Investigators
- Serge Beaulieu, Ph.D., Principal investigator, Douglas Mental Health University Institute / McGill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999765
- Sponsor's protocol ID
- BD-MBCT
- Status last verified
- May 2023
- First submitted
- 21 Oct 2009
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00999765
- Acronym / sponsor ID
- BD-MBCT
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Bipolar Depression, Mindfulness-Based Cognitive Therapy, MBCT, Maintenance, Euthymic, Efficacy, Feasibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Oct 2009 (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 evaluate the feasibility and short-term efficacy of MBCT as an add-on (i.e. patients must be stable with their regular mood stabilizing medication) for the maintenance therapy of bipolar disorder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder - stable | – | Behavioral: Mindfulness-Based Cognitive Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bipolar Disorder of third-line bipolar disorders program
Key inclusion criteria (5 listed)
- Males or females (>18 years old)
- Bipolar disorder (as per the Structured Clinical Interview for DSM Disorders (SCID)(22)), euthymic state: Complete remission for at least four weeks ((Montgomery and Asberg Rating Scale (MADRS) ≤ 6 and item-1 (depressed mood) = 0 and no suicidal ideations (MADRS(item-10) < 4)
- Must have had at least 3 depressive phases in the last 5 years
- Cooperative and willing to complete all the aspects of the study and especially the 45 minutes of exercise per day
- Must have completed a Secondary V (11th grade) education
Key exclusion criteria (13 listed)
- Other active psychiatric disorders (as per the SCID)
- Rapid cycling
- Bipolar disorder secondary to a medical condition or substance-induced mood disorder
- Suicidal ideations (MADRS(item 10)>3)
- Active i.e. unstable and/or untreated medical condition
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 |
|---|---|---|
| Mindfulness-Based Cognitive Therapyeight-week (two hours a week) group therapy (8-12 patients per group) | Behavioural | Bipolar Disorder - stable |
Primary outcome
number of weeks in which criteria are meet for a mood episode evaluate with the Longitudinal Interval Follow-up Evaluation (LIFE)
Time frame: 12 weeks (4 weeks post treatment)
4 secondary outcomes
Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale
Time frame: 2, 4, 6, 8 and 12 weeks
Change in intensity of subsyndromal symptoms of depression on the MADRS scale
Time frame: 2, 4, 6, 8 and 12 weeks
Change in intensity of subsyndromal symptoms of hypomania on the YMRS scale
Time frame: 2, 4, 6, 8 and 12 weeks
Change id intensity in subsyndromal symptoms of anxiety on the HAM-A scale
Time frame: 2,4,6,8 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
Related trials for Bipolar Disorder
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
RecruitingPhase 4
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
Depression, Bipolar
Active, not recruiting
Functional Remediation for Older Adults With Bipolar Disorder
Bipolar Disorder
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.
Serge Beaulieu, Ph.D. principal investigator
Douglas Mental Health University Institute / McGill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Douglas Mental Health University Institute at 1 site in Canada.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 15 May 2023. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 weeks in which criteria are meet for a mood episode evaluate with the Longitudinal Interval Follow-up Evaluation (LIFE) (time frame: 12 weeks (4 weeks post treatment)). 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 15 May 2023.