Bipolar DisorderMBCTNCT01126827
Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder
A study testing Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy in people with Bipolar Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of the study is to investigate the efficacy of mindfulness-based cognitive-behavior therapy (MBCT) for improvement of symptoms associated with bipolar disorder, by comparing MBCT to supportive psychotherapy. Patients who participate in this study will be randomly assigned to receive either 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Apr 2011
- 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
- MINI diagnostic criteria for any bipolar disorder (type I, type II, and NOS)
- Written informed consent
- Men or women aged 18-65
- No episodes of mania in the previous 4 weeks.
- Able to read and understand English.
Who cannot join
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
- History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc).
- History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months.
- Patients who have untreated hypothyroidism.
- Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bipolar Clinic and Research Program
Boston, Massachusetts, 02114
About this study
Official title: Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder: A Randomized, Controlled Study
The purpose of the study is to investigate the efficacy of mindfulness-based cognitive-behavior therapy (MBCT) for improvement of symptoms associated with bipolar disorder, by comparing MBCT to supportive psychotherapy. Patients who participate in this study will be randomly assigned to receive either
- state of the art group MBCT, or
- supportive group psychotherapy (which is considered part of the standard care available to patients at MGH).
Read the detailed description
We will conduct a randomized controlled trial of group MBCT (n=30) vs. SP (n=30) and compare the benefits and durability of MBCT vs. SP for decreasing symptoms in DSM-IV bipolar individuals over a 12-week period adjunctive to mood stabilizing medications coupled with individual-therapy sessions. We will also conduct follow-up assessments at 3, 6, 9, and 12 months after the active phase of the study. Subjects in the MBCT group will receive group therapy sessions of standardized yoga-meditation based exercises enhanced by psychoeducation and relapse prevention for bipolar disorder. Subjects in the SP group will receive support for coping with the symptoms of bipolar disorder, as well as psychoeducation about bipolar disorder. The focus of SP is on reflecting and expressing feelings about current life issues. Patients are supported and comforted when coping with difficult situations, depression, mood swings, or anger. We will assess mood, cognitive and psychosocial functioning before and after treatment for participants in both groups. Finally, we will investigate the functional neuroanatomy associated with memory impairment, attention, and mindful breathing in subjects with bipolar disorder as a predictor of treatment response using functional Magnetic Resonance Imaging (fMRI).
- Conditions
- Bipolar Disorder
- Being tested
- Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy
- Keywords
- Bipolar Disorder, Mood Disorders, Residual Symptoms, Depression, Mania, Hypomania, Bipolar, Bipolar I, Bipolar II
- Medical subject headings
- Bipolar Disorder, Mood Disorders, Depression, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive Behavioral Therapy or Supportive PsychotherapyBehavioural
12 weekly group therapy sessions
| Study group | Role | What they receive |
|---|---|---|
| Supportive Psychotherapy | Active comparator | Not described Receives: Behavioral: Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy |
| Mindfulness-Based Cognitive Behavioral Therapy | Active comparator | Not described Receives: Behavioral: Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAM-D) & Young Mania Rating Scale (YMRS)
HAM-D (depression severity) and YMRS (mania/hypomania severity) total scores will be evaluated as the primary outcome measures of mood symptoms of bipolar disorder as part of this trial.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Thilo Deckersbach, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126827
- Sponsor's protocol ID
- MBCT Randomized Study
- Acronym
- MBCT
- Status last verified
- Jul 2011
- First submitted
- 30 Apr 2010
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hanssen I, Huijbers M, Regeer E, Lochmann van Bennekom M, Stevens A, van Dijk P, Boere E, Havermans R, Hoenders R, Kupka R, Speckens AE. Mindfulness-based cognitive therapy v. treatment as usual in people with bipolar disorder: A multicentre, randomised controlled trial. Psychol Med. 2023 Oct;53(14):6678-6690. doi: 10.1017/S0033291723000090. Epub 2023 Mar 7.
PubMed 39625263
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder: A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT01126827
- Acronym / sponsor ID
- MBCT / MBCT Randomized Study
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Mood Disorders, Residual Symptoms, Depression, Mania, Hypomania, Bipolar, Bipolar I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 May 2010 (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 the study is to investigate the efficacy of mindfulness-based cognitive-behavior therapy (MBCT) for improvement of symptoms associated with bipolar disorder, by comparing MBCT to supportive psychotherapy. Patients who participate in this study will be randomly assigned to receive either
- state of the art group MBCT, or
- supportive group psychotherapy (which is considered part of the standard care available to patients at MGH).
Detailed description
We will conduct a randomized controlled trial of group MBCT (n=30) vs. SP (n=30) and compare the benefits and durability of MBCT vs. SP for decreasing symptoms in DSM-IV bipolar individuals over a 12-week period adjunctive to mood stabilizing medications coupled with individual-therapy sessions. We will also conduct follow-up assessments at 3, 6, 9, and 12 months after the active phase of the study. Subjects in the MBCT group will receive group therapy sessions of standardized yoga-meditation based exercises enhanced by psychoeducation and relapse prevention for bipolar disorder. Subjects in the SP group will receive support for coping with the symptoms of bipolar disorder, as well as psychoeducation about bipolar disorder. The focus of SP is on reflecting and expressing feelings about current life issues. Patients are supported and comforted when coping with difficult situations, depression, mood swings, or anger. We will assess mood, cognitive and psychosocial functioning before and after treatment for participants in both groups. Finally, we will investigate the functional neuroanatomy associated with memory impairment, attention, and mindful breathing in subjects with bipolar disorder as a predictor of treatment response using functional Magnetic Resonance Imaging (fMRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Psychotherapy | Active comparator | Behavioral: Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy |
| Mindfulness-Based Cognitive Behavioral Therapy | Active comparator | Behavioral: Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- MINI diagnostic criteria for any bipolar disorder (type I, type II, and NOS)
- Written informed consent
- Men or women aged 18-65
- No episodes of mania in the previous 4 weeks.
- Able to read and understand English.
Key exclusion criteria (5 listed)
- Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
- History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc).
- History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months.
- Patients who have untreated hypothyroidism.
- Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment.
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 Behavioral Therapy or Supportive Psychotherapy12 weekly group therapy sessions | Behavioural | Mindfulness-Based Cognitive Behavioral Therapy, Supportive Psychotherapy |
Primary outcome
Hamilton Rating Scale for Depression (HAM-D) & Young Mania Rating Scale (YMRS)
Time frame: 12 weeks
HAM-D (depression severity) and YMRS (mania/hypomania severity) total scores will be evaluated as the primary outcome measures of mood symptoms of bipolar disorder as part of this trial.
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 7 Jul 2011.
- Derived from this study: PubMed 39625263Hanssen I, Huijbers M, Regeer E, Lochmann van Bennekom M, Stevens A, van Dijk P, Boere E, Havermans R, Hoenders R, Kupka R, Speckens AE. Mindfulness-based cognitive therapy v. treatment as usual in people with bipolar disorder: A multicentre, randomised controlled trial. Psychol Med. 2023 Oct;53(14):6678-6690. doi: 10.1017/S0033291723000090. Epub 2023 Mar 7.
- MGH Bipolar Clinic and Research ProgramLink provided by the sponsor.
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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.
Thilo Deckersbach, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy in people with Bipolar Disorder, run by Massachusetts General Hospital at 1 site in United States.
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 5 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 7 Jul 2011. 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 United States. 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?
Hamilton Rating Scale for Depression (HAM-D) & Young Mania Rating Scale (YMRS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01126827, which also lists 1 linked publication.
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 7 Jul 2011.