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Trial registered on ANZCTR


Registration number
ACTRN12610000570088
Ethics application status
Approved
Date submitted
27/06/2010
Date registered
15/07/2010
Date last updated
22/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Brighten Your Mood Program: A randomized controlled trial of internet based treatment of depression for Chinese Australians
Scientific title
A randomized controlled trial of Internet based treatment for depression for Chinese Australians comparing immediate treatment vs. delayed treatment on symptoms of major depressive disorder.
Secondary ID [1] 252116 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 257662 0
Condition category
Condition code
Mental Health 257844 257844 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: 1) an immediate treatment group, or; 2) a delayed treatment group also known as a waitlist control group (beginnning the program 9 weeks after the immediate treatment group begin). All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for depression. All participants will complete 6 lessons of Internet based treatment about management of symptoms of depression. One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to complete. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people with depression, taking a further 20 minutes per summary. All participants will also receive automatic email and weekly reminder phone calls by a research assistant. The duration of the reminder emails/phone calls is expected to be 5-10 minutes per week. The duration of the program is 8weeks, but participants in the immediate treatment group will be contacted 3 months post program and asked to complete follow-up questionnaires. Study questionnaires will be administered at application, pre-education, post-education, and at 3-months post-education. These will take about 20-30 minutes to complete. The treatment materials are based on the Sadness Programs, which apply cognitive behavioural techniques such as psychoeducation about the symptoms and treatment of depression, behavioural activation, cognitive restructuring, graded exposure, behavioural experiments, and relapse prevention.
Intervention code [1] 256733 0
Treatment: Other
Intervention code [2] 256746 0
Behaviour
Comparator / control treatment
The delayed treatment group (beginnning the program 9 weeks after the immediate treatment group begins). This is a wait-list control group.
Control group
Active

Outcomes
Primary outcome [1] 258702 0
Depression is measured by the Chinese Patient Health Questionnaire 9-item (Chinese-PHQ-9)
Timepoint [1] 258702 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Primary outcome [2] 258703 0
Depression is measured by the Chinese Beck Depression Inventory (Chinese-BDI)
Timepoint [2] 258703 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [1] 264729 0
General levels of depression, anxiety and stress is measured by the Chinese 21-item Depression Anxiety Stress Scales (Chinese-DASS-21)
Timepoint [1] 264729 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [2] 264730 0
Disability is measured by the Chinese version of the Sheehan Disability Scale (Chinese-SDS)
Timepoint [2] 264730 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [3] 264731 0
Psychological distress is measured by the Chinese Kessler 10-item scale (Chinese-K-10)
Timepoint [3] 264731 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment

Eligibility
Key inclusion criteria
- Meet DSM-IV criteria for major depressive disorder
- Can speak fluent Cantonese or Mandarin
- Internet access + printer access
- Australian resident
- Be of Chinese origin
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current substance abuse/dependence
- Psychotic disorder or severe depression
- Current or planned psychological treatment during study duration
- Change in medications during last 1 month or intended change during study duration
- Suicidal

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)
Participants apply online, followed by a telephone interview to confirm diagnosis via structured diagnostic interview using the Chinese version of the Major Depressive Episode section of the Mini Neuropsychiatric Interview Schedule (MINI 5.0.0). Allocation concealment will occur by providing allocation details for each successive participant in a sealed envelope, which recruitment staff are required to open serially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a list generated prior to the study via a software program (www.random.org), at another site, in another country. The list will then be transcribed and details transferred to sealed envelopes.
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
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257215 0
Charities/Societies/Foundations
Name [1] 257215 0
BeyondBlue
Country [1] 257215 0
Australia
Primary sponsor type
University
Name
Clinical Research Unit for Anxiety and Depression (CRUfAD), School of Psychiatry, University of New South Wales
Address
299 Forbes Street Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 256465 0
None
Name [1] 256465 0
Address [1] 256465 0
Country [1] 256465 0
Other collaborator category [1] 251356 0
Individual
Name [1] 251356 0
Dr Stephen Li
Address [1] 251356 0
Core Pathology Services at the Institute of Clinical Pathology and Medical Research (ICPMR), Westmead Hospital, Westmead NSW 2145
Country [1] 251356 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259238 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 259238 0
Level 6, Jane Foss Russell Building - G02
The University of Sydney
NSW 2006
Ethics committee country [1] 259238 0
Australia
Date submitted for ethics approval [1] 259238 0
Approval date [1] 259238 0
18/05/2010
Ethics approval number [1] 259238 0
12436

Summary
Brief summary
The current study aims to reduce the practical and cultural barriers to mental health treatment for Chinese Australians by developing an Internet-based cognitive behavior therapy (ICBT) program for depression, based on the Sadness Program developed by Perini, Titov & Andrews (2009; www.virtualclinic.org.au) that is culturally sensitive and appropriate. A randomized controlled trial will compare the enhanced Chinese ICBT program for depression (the Brighten Your Mood Program) with telephone support to a waitlist control group. The project will examine the efficacy of the Internet Program in reducing symptoms of depression and disability in Chinese Australians, as well as its acceptability.
Trial website
www.virtualclinic.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31347 0
Address 31347 0
Country 31347 0
Phone 31347 0
Fax 31347 0
Email 31347 0
Contact person for public queries
Name 14594 0
Associate Professor Caroline Hunt
Address 14594 0
School of Psychology Transient Building – F12 The University of Sydney, Camperdown, NSW 2006
Country 14594 0
Australia
Phone 14594 0
+61 2 9351 5446
Fax 14594 0
Email 14594 0
[email protected]
Contact person for scientific queries
Name 5522 0
Associate Professor Caroline Hunt
Address 5522 0
School of Psychology Transient Building – F12 The University of Sydney, Camperdown, NSW 2006
Country 5522 0
Australia
Phone 5522 0
+61 2 9351 5446
Fax 5522 0
Email 5522 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
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