Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000247077
Ethics application status
Approved
Date submitted
23/03/2010
Date registered
24/03/2010
Date last updated
2/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Wellbeing Program: A randomized controlled trial of internet based treatment of anxiety and depression
Scientific title
A randomized controlled trial of Internet based treatment for anxiety and depression comparing immediate treatment vs. delayed treatment on symptoms of anxiety and depression.
Secondary ID [1] 1539 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social phobia (an anxiety disorder) 257011 0
Panic disorder (with or without agoraphobia) (both anxiety disorders) 257012 0
Generalised anxiety disorder (an anxiety disorder) 257013 0
Major depressive disorder (a depressive disorder) 257014 0
Condition category
Condition code
Mental Health 257174 257174 0 0
Depression
Mental Health 257175 257175 0 0
Anxiety

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 11 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, and/or social phobia and/or panic disorder (with or without agoraphobia) and/or generalised anxiety disorder (GAD). All participants will complete 8 lessons of Internet based treatment about management of symptoms of depression and anxiety. 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 anxiety, taking a further 20 minutes per summary. All participants will also receive automatic email and weekly reminder phone calls by a clinical psychologist, and have access to a clinician-moderated online forum discussing content of the program. The duration of the reminder emails/phone calls and contribution to the forum is expected to be 5-10 minutes per week. The duration of the program is 10 weeks, 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 Anxiety and Sadness Programs, which apply cognitive behavioural techniques.
Intervention code [1] 256194 0
Treatment: Other
Comparator / control treatment
The delayed treatment group (beginnning the program 11 weeks after the immediate treatment group begins). This is a wait-list control group.
Control group
Active

Outcomes
Primary outcome [1] 258059 0
Anxiety is measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Timepoint [1] 258059 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Primary outcome [2] 258060 0
Social phobia is measured by the Social Phobia Scale (SPS)
Timepoint [2] 258060 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Primary outcome [3] 258061 0
Social phobia is measured by the Social Interaction Anxiety Scale (SIAS)
Timepoint [3] 258061 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [1] 263642 0
Neuroticism is measured by using the NEO-Five Factor Inventory (NEO-FFI) Neuroticism scale
Timepoint [1] 263642 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [2] 263643 0
Disability is measured by the Sheehan Disability Scale (SDS)
Timepoint [2] 263643 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [3] 263644 0
Psychological distress is measured by the Kessler 10-item scale (K-10)
Timepoint [3] 263644 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [4] 263649 0
Panic disorder is measured by the Panic Disorder Severity Rating Scale - Self Report Version (PDSS-SR)
Timepoint [4] 263649 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [5] 263650 0
Generalised anxiety disorder is measured by the Penn State Worry Questionnaire (PSWQ)
Timepoint [5] 263650 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [6] 263651 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [6] 263651 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, social phobia and/or panic disorder (with or without agoraphobia) and/or GAD
- Internet access + printer access
- Australian resident
- Males and females
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
- Current or planned psychological treatment during study duration
- Change in medications during last 1 month or intended change during study duration
- Current use of benzodiazepines or beta-blockers.

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 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
25/03/2010
Actual
25/03/2010
Date of last participant enrolment
Anticipated
Actual
25/06/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256690 0
Government body
Name [1] 256690 0
National Health and Medical Research Council (NHMRC)
Country [1] 256690 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
NSW2010
Country
Australia
Secondary sponsor category [1] 255978 0
None
Name [1] 255978 0
Address [1] 255978 0
Country [1] 255978 0
Other collaborator category [1] 1160 0
Individual
Name [1] 1160 0
Dr Peter McEvoy
Address [1] 1160 0
Centre for Clinical Interventions (CCI)
223 James St Northbridge Western Australia 6003
Country [1] 1160 0
Australia
Other collaborator category [2] 1161 0
Individual
Name [2] 1161 0
Professor Michelle Craske
Address [2] 1161 0
Department of Psychology, University of California at Los Angeles (UCLA)
405 Hilgard Ave.,
Los Angeles, CA 90095-1563
Country [2] 1161 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258710 0
St Vincent's Hospital, Human Research Ethics Committee
Ethics committee address [1] 258710 0
Ethics committee country [1] 258710 0
Australia
Date submitted for ethics approval [1] 258710 0
Approval date [1] 258710 0
05/02/2010
Ethics approval number [1] 258710 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30971 0
Prof Nick Titov
Address 30971 0
Department of Psychology
Macquarie University
NSW 2109
Country 30971 0
Australia
Phone 30971 0
61 2 9850 9901
Fax 30971 0
Email 30971 0
[email protected]
Contact person for public queries
Name 14218 0
Associate Professor Nickolai Titov
Address 14218 0
Centre for Emotional Health/Department of Psychology
Macquarie University
C3B 518
NSW 2109
Country 14218 0
Australia
Phone 14218 0
+61 2 9850 9901
Fax 14218 0
+61 2 9850 8062
Email 14218 0
[email protected]
Contact person for scientific queries
Name 5146 0
Associate Professor Nickolai Titov
Address 5146 0
Centre for Emotional Health/Department of Psychology
Macquarie University
C3B 518
NSW 2109
Country 5146 0
Australia
Phone 5146 0
+61 2 9850 9901
Fax 5146 0
+61 2 9850 8062
Email 5146 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.