Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000961943
Ethics application status
Approved
Date submitted
6/09/2011
Date registered
7/09/2011
Date last updated
12/11/2018
Date data sharing statement initially provided
12/11/2018
Date results information initially provided
12/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised clinical effectiveness trial of a bipolar disorder clinic
Scientific title
For people with bipolar disorder, does participation in a Bipolar Disorder Clinic providing Interpersonal and Social Rhythm Therapy and medication management increase the time to relapse compared to usual care?
Secondary ID [1] 262990 0
HRC - 11/256
Universal Trial Number (UTN)
U1111-1124-2886
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 270716 0
Condition category
Condition code
Mental Health 270894 270894 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participation in a Bipolar Disorder Clinic involving Interpersonal and Social Rhythm Therapy and medication management over an 18 month period. The intervention will be delivered to individuals initially on a weekly basis, followed by fortnightly and then monthly. Apart from the initial 12 weekly sessions the frequency of sessions is determined by participant's needs. The psychotherapy sessions will be delivered by experienced psychotherapists (nurses and social workers) and are of 60 minutes duration. The medication management involves regular two-monthly sessions with a psychiatrist and additional sessions as required.
Intervention code [1] 269336 0
Rehabilitation
Intervention code [2] 269346 0
Lifestyle
Comparator / control treatment
Treatment as usual.This would usually involve care provided by general practitioner.
Control group
Active

Outcomes
Primary outcome [1] 279571 0
Lower rates of relapse at 18 months because of better self-management than patients randomised to general practice. The primary outcome measure is the Longitudinal Interval Follow-up Evaluation.
Timepoint [1] 279571 0
18 months
Secondary outcome [1] 287930 0
the Bipolar Disorder Clinic will prove more cost-effective than usual care over the 18 month intervention period. 1) A cost analysis of service use with all direct costs (inpatient admission; outpatient admission, emergency department visit, GP visit) taken into account. Data will be collected from computerised patient records for which an electronic protocol has been developed. All unit costs based on aggregated cost estimates derived from averaged CDHB data will be calculated from randomization for both intervention and control groups. In addition the costs associated with the intervention (therapist time and psychiatrist time) will be calculated in 30 minute units.
Timepoint [1] 287930 0
18 months

Eligibility
Key inclusion criteria
Patients with a diagnosis of bipolar disorder discharged from specialty mental health services.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be the primary diagnosis of a serious mental disorder such as schizophrenia or severe alcohol and drug dependence

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)
Subjects will be screened for inclusion and after signing informed consent will be randomised using the next allocation within the pre-generated randomsiation sequence. The investigator will contact the research associate who has the randomisation sequence and will confirm that inclusion criteria are met and informed consent gained, and will inform the investiagtor of the next random allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be computer generated in advance by the study statistician and arranged in permuted blocks. This sequence will be kept by a research associate who will be the only individual with access to this.
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
3/10/2011
Actual
3/10/2011
Date of last participant enrolment
Anticipated
Actual
12/08/2016
Date of last data collection
Anticipated
Actual
12/02/2018
Sample size
Target
100
Accrual to date
Final
88
Recruitment outside Australia
Country [1] 3826 0
New Zealand
State/province [1] 3826 0
Christchurch

Funding & Sponsors
Funding source category [1] 269802 0
Government body
Name [1] 269802 0
NZ Health Research Council
Country [1] 269802 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
PO Box 4345 Christchurch New Zealand 8140
Country
New Zealand
Secondary sponsor category [1] 268838 0
Hospital
Name [1] 268838 0
Canterbury District Health Board, Specialist Mental Health Services
Address [1] 268838 0
Hillmorton Hospital
Lincoln Road
Spreydon
Christchurch 8024
Country [1] 268838 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271766 0
Upper South Regional Ethics Committee
Ethics committee address [1] 271766 0
c/- Ministry of Health
PO Box 3877
Christchurch
8140
Ethics committee country [1] 271766 0
New Zealand
Date submitted for ethics approval [1] 271766 0
Approval date [1] 271766 0
08/12/2010
Ethics approval number [1] 271766 0
URB/10/11/044

Summary
Brief summary
This is a randomised controlled trial of a Bipolar Disorder Clinic in which one group of patients will receive usual care (usually general practice follow-up) and the other group will participate in a Bipolar Disorder Clinic that focuses on a combination of psychotherapy and medication management. The intervention focuses on promoting self-management skills such as medication use, early warning signs, lifestyle patterns, and triggers. The primary aim is to decrease the patients’ mood episodes and the secondary aim is to reduce service utilization and thus be more cost effective than usual care. The trial addresses a current gap in mental health care for bipolar disorder by examining the clinical effectiveness of a long-term model of care delivery that takes a patient-centred approach. It is envisaged that this pragmatic, multi-disciplinary study will enable patients with bipolar disorder to have more skills and confidence in managing their disorder.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 33117 0
Prof Marie Crowe
Address 33117 0
Dept of Psychological Medicine
University of Otago, PO Box4345 Christchurch
Country 33117 0
New Zealand
Phone 33117 0
+64 3 3720400
Fax 33117 0
Email 33117 0
marie.crowe@otago.ac.nz
Contact person for public queries
Name 16364 0
Prof Marie Crowe
Address 16364 0
Dept Psychological Medicine, University of Otago, Christchurch.

PO Box 4345
Christchurch 8140
Country 16364 0
New Zealand
Phone 16364 0
64 3 3720400
Fax 16364 0
64 3 3720407
Email 16364 0
Marie.crowe@otago.ac.nz
Contact person for scientific queries
Name 7292 0
Prof Marie Crowe
Address 7292 0
Dept Psychological Medicine, University of Otago, Christchurch.

PO Box 4345
Christchurch 8140
Country 7292 0
New Zealand
Phone 7292 0
64 3 3720400
Fax 7292 0
64 3 3720407
Email 7292 0
marie.crowe@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Ethics did not allow for this but we are looking into it.


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
SourceTitleYear of PublicationDOI
EmbaseClinical effectiveness trial of adjunctive interpersonal and social rhythm therapy for patients with bipolar disorder.2020https://dx.doi.org/10.1176/appi.psychotherapy.20190035
N.B. These documents automatically identified may not have been verified by the study sponsor.