Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000414011
Ethics application status
Approved
Date submitted
21/05/2010
Date registered
25/05/2010
Date last updated
10/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mindfulness-based Cognitive Therapy for Bipolar Disorder
Scientific title
A randomised controlled trial of mindfulness-based cognitive therapy versus treatment as usual for bipolar disorder and comorbid anxiety
Secondary ID [1] 251850 0
NA
Universal Trial Number (UTN)
U1111-1115-0862
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar disorder and co-morbid anxiety 257434 0
Condition category
Condition code
Mental Health 257579 257579 0 0
Other mental health disorders
Mental Health 257581 257581 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients allocated to the Mindfulness-Based Cognitive Therapy (MBCT) program would receive 8 weekly sessions of group therapy based on the MBCT treatment manual developed by Segal et al (2000). Modules include an explanation of mindfulness meditation from a cognitive perspective and a series of meditation practices including a breathing meditation, a body scan meditation and mindfulness of walking. Sessions are administered by a psychologist and last approximately 2 hours. Participants allocated to this condition also receive written education material about bipolar disorder on a weekly basis for 8 weeks.
Intervention code [1] 256533 0
Behaviour
Intervention code [2] 256543 0
Treatment: Other
Comparator / control treatment
Treatment as usual (TAU) (Standard Care). The TAU group will receive their usual care from their usual practitioner but will also receive written educational material about bipolar illness on a weekly basis for 8 weeks. The material will have the same content as those given to the MBCT condition.
Control group
Active

Outcomes
Primary outcome [1] 258501 0
Mean Montgomery Asberg Depression Rating Scale scores < 10
Timepoint [1] 258501 0
Baseline, Post, 3 month, 6 month, 9 month and 12 month follow up
Primary outcome [2] 258503 0
Mean Young Mania Rating Scale scores <7
Timepoint [2] 258503 0
Baseline, Post, 3 month, 6 month, 9 month and 12 month follow up
Secondary outcome [1] 264298 0
State-Trait Anxiety Inventory < 55
Timepoint [1] 264298 0
Baseline, Post, 3 month, 6 month, 9 month and 12 month follow up
Secondary outcome [2] 264300 0
The World Health Organization (WHO) Composite International Diagnostic Interview (CIDI) - No anxiety disorder diagnoses met in the past 12 months
Timepoint [2] 264300 0
Baseline, 12 month follow up

Eligibility
Key inclusion criteria
(i) lifetime Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of bipolar I or II disorder, (ii) able to be maintained on a mood stabilizing medication for the duration of treatment, (iii) be at least 18 years of age, (iv) at least secondary school education, (v) be able to provide informed consent, (vi) be fluent in written and spoken English, (vii) be currently under the care of a General medical Practitioner or psychiatrist who would review medication as necessary, (viii) have experienced at least one bipolar disorder episode (hypo/mania, depression, mixed episode) over the past 18 months, and (ix) have a lifetime incidence of at least 3 bipolar episodes.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) currently experiencing a bipolar episode (either depressed or (hypo)manic - patients would be required to be reassessed for the study once their symptoms had remitted), (ii) diagnosis of schizophrenia or schizoaffective disorder, current substance abuse disorder, organic brain syndrome, antisocial or borderline personality disorder, (iii) concurrent significant medical condition impeding ability to participate, and (iv) receiving formalised psychological therapy while in treatment phase of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via computer. An independent researcher not involved with the trial or participants will conduct the randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/07/2008
Actual
24/07/2008
Date of last participant enrolment
Anticipated
Actual
5/05/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 257023 0
Charities/Societies/Foundations
Name [1] 257023 0
Australian Rotary Health Research Fund
Country [1] 257023 0
Australia
Primary sponsor type
University
Name
University of NSW
Address
School of Psychiatry
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 256280 0
Charities/Societies/Foundations
Name [1] 256280 0
Black Dog Institute
Address [1] 256280 0
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country [1] 256280 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259039 0
University of NSW - Human Research Ethics Committee
Ethics committee address [1] 259039 0
Ethics committee country [1] 259039 0
Australia
Date submitted for ethics approval [1] 259039 0
01/02/2008
Approval date [1] 259039 0
26/02/2008
Ethics approval number [1] 259039 0
HREC08039

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31203 0
A/Prof Vijaya Manicavasagar
Address 31203 0
Black Dog Institute
Country 31203 0
Australia
Phone 31203 0
0293828503
Fax 31203 0
Email 31203 0
[email protected]
Contact person for public queries
Name 14450 0
Tania Perich
Address 14450 0
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country 14450 0
Australia
Phone 14450 0
612 9382 9266
Fax 14450 0
Email 14450 0
[email protected]
Contact person for scientific queries
Name 5378 0
Tania Perich
Address 5378 0
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country 5378 0
Australia
Phone 5378 0
+61 2 9382 3841
Fax 5378 0
Email 5378 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.