Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000133235
Ethics application status
Not yet submitted
Date submitted
22/01/2009
Date registered
25/02/2009
Date last updated
25/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The evaluation of a program for people with bipolar disorder in community settings
Scientific title
Do patients with bipolar disorder accessing a psychosocial program in community settings when compared to participants in a randomised control trial have similar outcomes regarding relapse and service utilisation.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bipolar disorder 4226 0
Condition category
Condition code
Mental Health 4444 4444 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The psychosocial program "MAPS: A guide to managing bipolar disorder" comprises 10 weekly sessions (+ one booster session held one month after the conclusion of the weekly sessions). The program aims to provide information and develop coping strategies to enable participants to effectively manage bipolar disorder. The acronym "MAPS" refers to the coping strategies taught throughout the program (monitoring, assessing, preventing relapse, SMART goal setting). The program will be conducted by trained mental health professionals in public and private community settings eg. primary care, private practice, day programs. The duration of each session is 1 hour for individuals or 2 hours for groups.
Intervention code [1] 3943 0
Treatment: Other
Comparator / control treatment
The intervention in this study will be compared to the intervention and control arm of a randomised controlled trial (RCT) that has already been completed.
In the RCT, the treatment group received the psychosocial program "MAPS: A guide to managing bipolar disorder" in addition to treatment as usual. The program was delivered in a group format over 12 weekly sessions (+ 3 booster sessions) of 1 1/2 hours duration. (The format of the program has been revised to be consistent with the Better Access to Mental Health Care medicare items). The control group received treatment as usual which consisted of care from a psychiatrist or GP and medication if prescribed.
This RCT is not registered on a publically available Register.
Control group
Historical

Outcomes
Primary outcome [1] 5327 0
relapse of any mood episode (measured according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
Timepoint [1] 5327 0
baseline, and then monthly after intervention completion for 9 months
Secondary outcome [1] 8958 0
Service utilisation using the Diagnostic Interview for psychosis - Service Utilisation module
Timepoint [1] 8958 0
baseline and 12 months

Eligibility
Key inclusion criteria
DSM-IV diagnosis of bipolar disorder
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to read or write in English at a primary school level

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4407 0
Charities/Societies/Foundations
Name [1] 4407 0
Medical Benefits Fund (MBF) Foundation
Country [1] 4407 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital (Melbourne)
Address
P.O. Box 2900
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 3966 0
University
Name [1] 3966 0
University of Melbourne
Address [1] 3966 0
The University of Melbourne
Victoria 3010
Country [1] 3966 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6456 0
St Vincent's Hospital Human Research Ethics Committee-A
Ethics committee address [1] 6456 0
P.O. Box 2900
Fitzroy 3065
Ethics committee country [1] 6456 0
Australia
Date submitted for ethics approval [1] 6456 0
03/12/2008
Approval date [1] 6456 0
Ethics approval number [1] 6456 0
HREC/A 149/08

Summary
Brief summary
This study is a follow up study to a randomised control trial of a self-management program for people with bipolar disorder. We would like to see if participants receiving the program when delivered by mental health professionals in community settings (public or private) achieve similar outcomes to those involved in the first trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29210 0
Address 29210 0
Country 29210 0
Phone 29210 0
Fax 29210 0
Email 29210 0
Contact person for public queries
Name 12457 0
Monica Gilbert
Address 12457 0
Frameworks for Health
St Vincent's Hospital (Melbourne)
P.O. Box 2900
Fitzroy 3065
Country 12457 0
Australia
Phone 12457 0
613 9288 2293
Fax 12457 0
613 9288 2360
Email 12457 0
[email protected]
Contact person for scientific queries
Name 3385 0
Professor David Castle
Address 3385 0
St Vincent's Hospital (Melbourne)
P.O. Box 2900
Fitzroy 3065
Country 3385 0
Australia
Phone 3385 0
613 9288 4751
Fax 3385 0
Email 3385 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.