Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000411347
Ethics application status
Approved
Date submitted
4/07/2007
Date registered
22/08/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using the web to improve knowledge and self-management of Bipolar Disorder: A randomised controlled trial
Scientific title
Using a web-based psycho-education program to improve knowledge and self-management of Bipolar Disorder: A randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Newly diagnosed (within six months) Bipolar Disorder (BD). 2175 0
Condition category
Condition code
Mental Health 2270 2270 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are Three different conditions in this study: two treatment and one minimal attention (control). All conditions involve web-based information/education, delivered over 8 consecutive weeks, about BD.
(1) BEP: This is the basic online Bipolar Education Program (BEP). The BEP consists of 8 web-based modules, which participants receive one per week, covering information about diagnosis, causes, treatments, management of BD as well as testimonies from well-known people with BD. Participants complete and submit workbook tasks related to each of the modules.
(2) BEP+ Enhanced Informed Support: This condition consists of the online BEP described above as well as receiving weekly email support from an informed support person. The “Informed Supporter” is someone who is successfully managing their BD and trained to provide email support to participants. In addition the "informed supporter" will help to develop and implement a ‘Stay-Well Plan”. A “Stay Well Plan” consists of strategies to help people manage their BD.
Intervention code [1] 1873 0
Other interventions
Comparator / control treatment
(3) Control: This condition is a minimal attention condition with 8 weekly emails containing attachments of information relating BD.
Control group
Active

Outcomes
Primary outcome [1] 3133 0
Mean understanding and self-control of Bipolar Disorder (Brief Illness Perception Questionnaire).
Timepoint [1] 3133 0
Baseline, post-intervention, 3 and 6 months after intervention
Secondary outcome [1] 5261 0
Mean work and social adjustment (Work and Social Adjustment Scale)
Timepoint [1] 5261 0
baseline, post-intervention, 3 and 6 months after intervention
Secondary outcome [2] 5262 0
Mood and functional impairment (Mood and Functioning Chart)
Timepoint [2] 5262 0
baseline, post-intervention, 3 and 6 months after intervention
Secondary outcome [3] 5263 0
Mean anxiety and depression scores (Goldberg Anxiety and Depression Questionnaire)
Timepoint [3] 5263 0
baseline, post-intervention, 3 and 6 months after intervention
Secondary outcome [4] 5264 0
Mean bipolar disorder literacy (A specifically-designed instrument has been developed for this study consisting of 32 questions and measuring participants? knowledge of the causes, diagnosis and treatments of bipolar disorder, as well as how to develop a wellbeing plan. Higher scores represent greater bipolar literacy.)
Timepoint [4] 5264 0
baseline, post-intervention, 3 and 6 months after intervention
Secondary outcome [5] 5266 0
Mean self-esteem (Rosenberg Self Esteem Inventory)
Timepoint [5] 5266 0
baseline, post-intervention, 3 and 6 months after intervention
Secondary outcome [6] 5267 0
Mean health locus of control (Multi-dimensional Health Locus of Control Scale)
Timepoint [6] 5267 0
baseline, post-intervention, 3 and 6 months after intervention
Secondary outcome [7] 5268 0
Mean satisfaction with life (Satisfaction with Life Scale)
Timepoint [7] 5268 0
baseline, post-intervention, 3 and 6 months after intervention

Eligibility
Key inclusion criteria
Received diagnosis of Bipolar Disorder from a General Practitioner or Psychiatrist within last twelve months.Has a managing health professional who takes responsibility for the treatment of their bipolar disorder and whom they see regularly. Has access to internet, email and printer, and is computer-literate.Living in Australia.Able to read and write English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
under 18 years of age
Was diagnosed with Bipolar disorder more than 12months ago
Does not have a managing health professional
Does not have access to the internet
Does not live in Australia

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Two staff members not involved in the study hold the random allocation schedule and they randomly allocate consenting participants (by ID) to one of the three conditions, after which they inform the research staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation (ie simple randomization into 3 groups using an excel macro).
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
Recruiting
Date of first participant enrolment
Anticipated
12/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2433 0
Charities/Societies/Foundations
Name [1] 2433 0
Australian Rotary Health Research Fund
Country [1] 2433 0
Australia
Funding source category [2] 2434 0
Government body
Name [2] 2434 0
National Health and Medical Research Council
Country [2] 2434 0
Australia
Primary sponsor type
Individual
Name
Dr Judy Proudfoot, Black Dog Institute, University of NSW
Address
Black Dog Institute and University of New South Wales
Hospital Rd
Prince of Wales Hospital
Randwick
NSW, 2031
Country
Australia
Secondary sponsor category [1] 3365 0
None
Name [1] 3365 0
Address [1] 3365 0
Country [1] 3365 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4286 0
Human Research Ethics Committee, University of New South Wales
Ethics committee address [1] 4286 0
University of UNSW, HREC
Rupert Myers Building,
C/o Research Office/Ethics,
Gate 14, Barker Street,
Kensington,
NSW, 2033
Ethics committee country [1] 4286 0
Australia
Date submitted for ethics approval [1] 4286 0
Approval date [1] 4286 0
25/10/2006
Ethics approval number [1] 4286 0
06253

Summary
Brief summary
Aim: to determine whether the web-based Bipolar Education Program (BEP) improves understanding and control of bipolar disorder, as well as mood, functioning and psycho-social adjustment in adults with newly diagnosed with bipolar disorder, in comparison with a minimal online education control condition. Two versions of the bipolar education program will be evaluated:(a)on its own and (b)with email support from an informed supporter who will also provide structured assistance to implement a ‘stay-well’ self-management plan. Informed supporters are people with bipolar disorder who are effectively self-managing their condition and who will be trained to provide online support for the education program under supervision of our clinical team.
Hypotheses: At post-intervention and follow-up (3 and 6 months post-intervention):
1. Participants who receive the Bipolar Education Program (BEP) will have greater understanding of bipolar disorder, report greater control and self-management of their condition, and experience a better illness trajectory (fewer depressive and manic/hypomanic episodes, symptoms and impairment, fewer hospitalizations) and better psycho-social functioning than the attention control group.
2. Participants who receive the full BEP package (BEP + email support from an informed supporter with assistance to develop and implement a ‘stay well’ plan) will have greater understanding of bipolar disorder, report greater control and self-management of their condition, and experience a better illness trajectory (fewer depressive and manic/hypomanic episodes, symptoms and impairment, fewer hospitalizations) and better psycho-social functioning than people receiving the BEP alone or the attention control condition.
3. People receiving the full BEP package will report greater satisfaction with the intervention than those in the other BEP conditions and in the attention control condition.
4. The health service costs associated with hospitalizations and visits to health practitioners will be significantly different between the groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27687 0
Address 27687 0
Country 27687 0
Phone 27687 0
Fax 27687 0
Email 27687 0
Contact person for public queries
Name 11062 0
Dr Judy Proudfoot
Address 11062 0
Black Dog Institute & University of NSW
Hospital Road
Randwick NSW 2031
Country 11062 0
Australia
Phone 11062 0
+61 2 93823767
Fax 11062 0
+61 2 93828207
Email 11062 0
[email protected]
Contact person for scientific queries
Name 1990 0
Dr Judy Proudfoot
Address 1990 0
Black Dog Institute & University of NSW
Hospital Road
Randwick NSW 2031
Country 1990 0
Australia
Phone 1990 0
+61 2 93823767
Fax 1990 0
+61 2 93828207
Email 1990 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
SourceTitleYear of PublicationDOI
Dimensions AIMechanisms underpinning effective peer support: a qualitative analysis of interactions between expert peers and patients newly-diagnosed with bipolar disorder2012https://doi.org/10.1186/1471-244x-12-196
N.B. These documents automatically identified may not have been verified by the study sponsor.