ANZCTR - Registration

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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).

Condition category

Condition code

Mental Health

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]

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]

Mean understanding and self-control of Bipolar Disorder (Brief Illness Perception Questionnaire).

Timepoint [1]

Baseline, post-intervention, 3 and 6 months after intervention

Secondary outcome [1]

Mean work and social adjustment (Work and Social Adjustment Scale)

Timepoint [1]

baseline, post-intervention, 3 and 6 months after intervention

Secondary outcome [2]

Mood and functional impairment (Mood and Functioning Chart)

Timepoint [2]

baseline, post-intervention, 3 and 6 months after intervention

Secondary outcome [3]

Mean anxiety and depression scores (Goldberg Anxiety and Depression Questionnaire)

Timepoint [3]

baseline, post-intervention, 3 and 6 months after intervention

Secondary outcome [4]

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]

baseline, post-intervention, 3 and 6 months after intervention

Secondary outcome [5]

Mean self-esteem (Rosenberg Self Esteem Inventory)

Timepoint [5]

baseline, post-intervention, 3 and 6 months after intervention

Secondary outcome [6]

Mean health locus of control (Multi-dimensional Health Locus of Control Scale)

Timepoint [6]

baseline, post-intervention, 3 and 6 months after intervention

Secondary outcome [7]

Mean satisfaction with life (Satisfaction with Life Scale)

Timepoint [7]

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]

Charities/Societies/Foundations

Name [1]

Australian Rotary Health Research Fund

Address [1]

Australian Rotary Health Research Fund
P.O. Box 3455
Parramatta,
NSW, 2150

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council

Address [2]

GPO Box 1421 Canberra ACT 2601

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee, University of New South Wales

Ethics committee address [1]

University of UNSW, HREC 
Rupert Myers Building,
C/o Research Office/Ethics,
Gate 14, Barker Street,
Kensington,
NSW, 2033

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/10/2006

Ethics approval number [1]

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

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Dr Judy Proudfoot

Address

Black Dog Institute & University of NSW
Hospital Road
Randwick NSW 2031

Country

Australia

Phone

+61 2 93823767

Fax

+61 2 93828207

Email

[email protected]

Contact person for scientific queries

Name

Dr Judy Proudfoot

Address

Black Dog Institute & University of NSW
Hospital Road
Randwick NSW 2031

Country

Australia

Phone

+61 2 93823767

Fax

+61 2 93828207

Email

[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

Source	Title	Year of Publication	DOI
Dimensions AI	Mechanisms underpinning effective peer support: a qualitative analysis of interactions between expert peers and patients newly-diagnosed with bipolar disorder	2012	https://doi.org/10.1186/1471-244x-12-196

N.B. These documents automatically identified may not have been verified by the study sponsor.