NCT01126827

Brief 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. 1.state of the art group MBCT, or
  2. 2.supportive group psychotherapy (which is considered part of the standard care available to patients at MGH).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2010

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

July 7, 2011

Status Verified

July 1, 2011

Enrollment Period

1.2 years

First QC Date

April 30, 2010

Last Update Submit

July 6, 2011

Conditions

Bipolar Disorder

Keywords

Bipolar DisorderMood DisordersResidual SymptomsDepressionManiaHypomaniaBipolarBipolar IBipolar II

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Study Arms (2)

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

Interventions

Mindfulness-Based Cognitive Behavioral Therapy or Supportive PsychotherapyBEHAVIORAL

12 weekly group therapy sessions

Mindfulness-Based Cognitive Behavioral TherapySupportive Psychotherapy

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bipolar Clinic and Research Program

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 39625263DERIVED

Related Links

MeSH Terms

Conditions

Bipolar DisorderMood DisordersDepressionMania

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMental DisordersBehavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thilo Deckersbach, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 30, 2010

First Posted

May 20, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

July 7, 2011

Record last verified: 2011-07

Locations

US(1)