Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000377932
Ethics application status
Not yet submitted
Date submitted
12/04/2011
Date registered
12/04/2011
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of an online bulletin board for depression
Scientific title
The effectiveness of an internet-based bulletin board on depressive symptoms and quality of life in community members with current or previous history of depression.
Secondary ID [1] 253612 0
Nil
Universal Trial Number (UTN)
Trial acronym
ShareIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 261171 0
Condition category
Condition code
Mental Health 259325 259325 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Intervention condition. The intervention condition involves participants visiting and posting to an online bulletin board for depression called BlueBoard. BlueBoard is a free, online supportive bulletin board that has been developed and is provided by researchers at CMHR, ANU. The board can be accessed 24 hours a day and is monitored by trained moderators between the hours of 7am and 10pm, 7 days a week. The board is moderated to ensure the appropriateness of posted material and to protect the safety of the members of the board. Participants allocated to the BlueBoard intervention will nominate a username (not their real name) and password to access the board and will be encouraged to use the board for a period of 6 months. Participants will receive automatically generated e-mails reminding them to use the board if they have not logged on to the board for 14 days or longer.
Intervention code [1] 264384 0
Treatment: Other
Comparator / control treatment
Arm 2: Wait-listed control condition. In the control condition, participants will be waitlisted to use the online board after a delay of 6 months.
Control group
Active

Outcomes
Primary outcome [1] 266505 0
Change in mean depression score (Centre for Epidemiologic Studies Depression Scale (CES-D)
Timepoint [1] 266505 0
Baseline, post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention
Secondary outcome [1] 273906 0
Change in mean anxiety score (GAD-7)
Timepoint [1] 273906 0
Baseline, post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention
Secondary outcome [2] 273907 0
Change in mean quality of life score (EUROHIS-8)
Timepoint [2] 273907 0
Baseline, post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention
Secondary outcome [3] 273908 0
Change in days lost and days unproductive due to emotional problems (4 items from Sheehan Disability Scales)
Timepoint [3] 273908 0
Baseline, post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention
Secondary outcome [4] 273909 0
Change in self-stigma (Self-Stigma of Depression Scale)
Timepoint [4] 273909 0
Baseline, post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention
Secondary outcome [5] 273910 0
Types of treatments used to treat depression (self-report, selected from a provided list of treatments)
Timepoint [5] 273910 0
Baseline, post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention
Secondary outcome [6] 273911 0
Change in self-esteem (Rosenberg Self Esteem Scale)
Timepoint [6] 273911 0
Baseline, post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention
Secondary outcome [7] 273912 0
Change in mental well-being (Warwick-Edinburgh Mental Wellbeing Scale)
Timepoint [7] 273912 0
Baseline, post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention
Secondary outcome [8] 273913 0
Change in empowerment (Empowerment Scale)
Timepoint [8] 273913 0
Baseline, post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention
Secondary outcome [9] 273914 0
Change in self-compassion (Self-Compassion Scale - Short form)
Timepoint [9] 273914 0
Baseline, post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention
Secondary outcome [10] 273915 0
Change in social support (MOS Social Support Survey and UCLA Loneliness Scale)
Timepoint [10] 273915 0
Baseline, post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention
Secondary outcome [11] 273916 0
Website participation and usage (amount of the intervention completed using a graded scale)
Timepoint [11] 273916 0
post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention
Secondary outcome [12] 273934 0
Satisfaction with the intervention (Likert scale)
Timepoint [12] 273934 0
post-intervention (6 weeks post baseline), 6 months post-intervention, 12 months post-intervention

Eligibility
Key inclusion criteria
Aged 18 years or older
Regular access to the Internet
A current, regularly used e-mail address
Current diagnosis of depression or symptoms of depression, or a history of depression
Willingness to regularly participate in an online bulletin board support group
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current or past diagnosis of bipolar disorder, schizophrenia or psychosis
Current involvement in an online or face-to-face support group for depression

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)
Partcipants will be recruited by a variety of means including advertisements and/or press releases on Facebook, on relevant websites, and using flyers to be distributed to and by health and other relevant organisations. The advertisement will contain brief information about the project and will direct those interested in participating to a website containing further information about the project.

On the project website, potential participants will be provided with information about the project and will be asked to answer some simple screening questions to determine their eligibility for the trial.

If eligible, participants will be directed to an additional webpage containing more detailed information about the project (including issues concerning withdrawal, confidentiality, time involved) and contact information for the researchers and the ANU Human Ethics Research Committee. The information also forms the content of the Participant Information Sheet which is available on all project portal web-pages as a printable pdf. If they agree to continue their enrolment in the trial, on the next web-page the participant must then answer a series of questions as ‘yes’ before they can proceed with their participation.
Ineligible participants will be directed to a webpage containing information about various online services developed by CMHR that might be of interest, including information about BlueBoard.

Eligible participants who provide their consent will be directed to a webpage asking them to enter their e-mail address. In order to verify their e-mail address, participants will be automatically sent an e-mail containing a unique link that they will be asked to click to verify their e-mail address. The link directs the participant to a webpage that prompts them to create a username and password which they will use to log in to both the project webportal and BlueBoard. In order to protect the identity of the participant, the username will require approval by project staff before the participant can proceed. This step is required to ensure that the username does not contain any identifying information. Once a username is approved, the participant will be e-mailed a link to the project web portal and asked to log on with their username and password to complete the baseline survey.

Following completion of the baseline survey, participants will be randomised to either the intervention or control condition. Participants will then be directed to a webpage informing them of their allocated condition and relevant instructions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted by a researcher (AM) who is not involved in the day to day running of the trial and is physically located in a different institution to where the recruitment of participants is taking place.

Participants will be randomised using automatised compuer software following completion of the baseline survey. Randomisation is stratified by severity of symptoms.
Masking / blinding
Open (masking not 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
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 3912 0
All postcodes
Recruitment outside Australia
Country [1] 3200 0
New Zealand
State/province [1] 3200 0
All
Country [2] 3201 0
United States of America
State/province [2] 3201 0
All
Country [3] 3202 0
Canada
State/province [3] 3202 0
All
Country [4] 3203 0
United Kingdom
State/province [4] 3203 0
All

Funding & Sponsors
Funding source category [1] 264861 0
Government body
Name [1] 264861 0
National Health and Medical Research Council
Country [1] 264861 0
Australia
Primary sponsor type
Individual
Name
Prof Kathleen Griffiths
Address
Building 63, Eggleston Rd
The Australian National University
Canberra ACT 0200
Country
Australia
Secondary sponsor category [1] 263960 0
Individual
Name [1] 263960 0
Ms Lou Farrer
Address [1] 263960 0
Building 63, Eggleston Rd
The Australian National University
Canberra ACT 0200
Country [1] 263960 0
Australia
Secondary sponsor category [2] 263961 0
Individual
Name [2] 263961 0
Ms Dimity Crisp
Address [2] 263961 0
Building 63, Eggleston Rd
The Australian National University
Canberra ACT 0200
Country [2] 263961 0
Australia
Secondary sponsor category [3] 263962 0
Individual
Name [3] 263962 0
Ms Sara Vassallo
Address [3] 263962 0
Building 63, Eggleston Rd
The Australian National University
Canberra ACT 0200
Country [3] 263962 0
Australia
Secondary sponsor category [4] 263963 0
Individual
Name [4] 263963 0
Ms Kylie Bennett
Address [4] 263963 0
Building 63, Eggleston Rd
The Australian National University
Canberra ACT 0200
Country [4] 263963 0
Australia
Secondary sponsor category [5] 263964 0
Individual
Name [5] 263964 0
Mr Anthony Bennett
Address [5] 263964 0
Building 63, Eggleston Rd
The Australian National University
Canberra ACT 0200
Country [5] 263964 0
Australia
Secondary sponsor category [6] 263965 0
Individual
Name [6] 263965 0
Ms Julia Reynolds
Address [6] 263965 0
Building 63, Eggleston Rd
The Australian National University
Canberra ACT 0200
Country [6] 263965 0
Australia
Other collaborator category [1] 251939 0
Individual
Name [1] 251939 0
Prof Andrew Mackinnon
Address [1] 251939 0
Orygen Youth Health Research Centre
35 Poplar Rd
Parkville VIC 3052
Country [1] 251939 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266824 0
Australian National University Human Ethics Committee
Ethics committee address [1] 266824 0
Office of Research Integrity
Research Office
Chancelry 10B, Lower Ground Floor
East Road
Australian National University
Acton ACT 0200
Ethics committee country [1] 266824 0
Australia
Date submitted for ethics approval [1] 266824 0
13/04/2011
Approval date [1] 266824 0
Ethics approval number [1] 266824 0
2011/037

Summary
Brief summary
This project is a randomised controlled trial of an established online bulletin board for depression. It has been estimated that millions of people worldwide use peer-to-peer bulletin boards, forums or internet support groups (ISGs) for health conditions. However, little is known about the effectiveness of these groups in terms of symptom reduction or improvement in quality of life. To our knowledge, this is the first randomised controlled trial of the effectiveness of a pre-existing, well-established online bulletin board for depression in the community.

The aims of the project are to determine whether BlueBoard, an established online bulletin board for depression, improves mental health, quality of life, and related outcomes among members of the community with high levels of self-reported psychological distress and previous history or current experience of depression.
Trial website
To be created.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32218 0
Dr Lou Farrer
Address 32218 0
Centre for Mental Health Research, ANU. 63 Eggleston Rd, The Australian National University, Canberra ACT 2601
Country 32218 0
Australia
Phone 32218 0
+61 2 6125 8859
Fax 32218 0
Email 32218 0
[email protected]
Contact person for public queries
Name 15465 0
Dr Lou Farrer
Address 15465 0
Building 63, Eggleston Rd
The Australian National University
Canberra ACT 0200
Country 15465 0
Australia
Phone 15465 0
+61 2 6125 8859
Fax 15465 0
+61 2 6125 0733
Email 15465 0
[email protected]
Contact person for scientific queries
Name 6393 0
Prof Professor Kathy Griffiths
Address 6393 0
Building 63, Eggleston Rd
The Australian National University
Canberra ACT 0200
Country 6393 0
Australia
Phone 6393 0
+61 2 6125 9723
Fax 6393 0
+61 2 6125 0733
Email 6393 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.