Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000118404
Ethics application status
Approved
Date submitted
7/02/2007
Date registered
9/02/2007
Date last updated
10/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Moodswings: An online intervention program for bipolar disorder
Scientific title
Moodswings: A randomised controlled trial investigating an online intervention program for bipolar disorder on episdoes of illness and a range of psychiatric rating scales
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 1610 0
Condition category
Condition code
Neurological 1715 1715 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Online Cognitive Behavioural Therapy (CBT) intervention vs online information only as comparable control. The CBT intervention includes information about bipolar disorder along with interactive skills and strategies designed to help manage the disorder, including (but not limted to ) mood monitoring, activity scheduling, goal setting and problem solving.
Intervention code [1] 1585 0
Treatment: Other
Comparator / control treatment
The information control group will have access only to information on bipolar disorder. Participants progress through the web site models in a set sequence, with 2 weeks allowed for each module. Participants acess of modules is recorded automatically, noting the specific module and duration of time spent. If a participant has not loged onto the program for 4 days a reminder email is sent. Participants will have access to the website for 12 months.
Control group
Active

Outcomes
Primary outcome [1] 2386 0
To test the hypotheses that an online CBT intervention for bipolar disorder is more effective than information only comparable control condition in reducing the number and severity of episodes of relapses
Timepoint [1] 2386 0
Measured over 12 months
Secondary outcome [1] 4149 0
Mood symptoms - Montgomery Asberg Depression Rating Scale – Self Report (MADRS-S); Altman Self-Rating Mania Scale; Bipolar Composite Scale; Global Measure of Severity of Depression (GSEVDEP), Global Measure of Severity of Mania (GSEVMANIA). Adherence to Medication; Medication Adherence Rating Scale (MARS). Improvement in functionality, Global Measure of Psychosocial Functioning – depression (GPF-DEP), Global Measure of Psychosocial Functioning (GPF-MANIA). Quality of life: Global Quality of Life. (GQOL), and social support.
Timepoint [1] 4149 0
Secondary outcomes will be measured at baseline, 3 months, 6 months and 12 months.

Eligibility
Key inclusion criteria
DSM-IV diagnosis of bipolar disorder (I, II or NOS).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of developmental disability or amnesic syndrome that would impair ability to learn from the intervention.

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 by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
participants are blinded to their allocation of active intervention (CBT) or comparable control (information only)
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1865 0
Charities/Societies/Foundations
Name [1] 1865 0
The beyondblue Victorian Centre of Excellence in Depression and Related Disorders
Country [1] 1865 0
Australia
Primary sponsor type
Individual
Name
Professor Michael Berk
Address
Barwon Health, The Geelong Hospital Kitchener House, PO Box 281Geelong Vic 3220
Country
Australia
Secondary sponsor category [1] 1682 0
None
Name [1] 1682 0
Nil
Address [1] 1682 0
Country [1] 1682 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3474 0
Barwon Health ethics committee
Ethics committee address [1] 3474 0
Ethics committee country [1] 3474 0
Australia
Date submitted for ethics approval [1] 3474 0
Approval date [1] 3474 0
Ethics approval number [1] 3474 0

Summary
Brief summary
This study evaluates the effectiveness of on an on-line web based intervention for bipolar disorder. The intervention utilises techniques and strategies found to be successful in previous psychosocial interventions conducted in face-to-face groups. The study also uses the experience of similar online studies in the area of unipolar depression and anxiety.The intervention comprises a number of modules including an introduction to the project, understanding bipolar disorder, stress and triggers of illness, medication management, managing and monitoring prodromes of depression, mania and hypomania and relapse prevention plans. The modules contain psycho-education along with specific strategies for participants to utilize in the management of the illness. The intervention also contains a moderated discussion board to develop a sense of support between participants and reduce feelings of stigma and isolation. The active intervention group described will be compared to an online information only group with moderated discussion.
Trial website
www.moodswings.net.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27519 0
Address 27519 0
Country 27519 0
Phone 27519 0
Fax 27519 0
Email 27519 0
Contact person for public queries
Name 10774 0
Sue Lauder
Address 10774 0
Barwon Health, The Geelong Hospital
Kitchener House,
PO Box 281Geelong Vic 3220
Country 10774 0
Australia
Phone 10774 0
+61 3 5226 7488
Fax 10774 0
+61 3 5246 5165
Email 10774 0
[email protected]
Contact person for scientific queries
Name 1702 0
Professor Michael Berk
Address 1702 0
Barwon Health, The Geelong Hospital
Kitchener House,
PO Box 281Geelong Vic 3220
Country 1702 0
Australia
Phone 1702 0
+61 3 5260 3154
Fax 1702 0
+61 3 5246 5165
Email 1702 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.