Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000555055
Ethics application status
Approved
Date submitted
7/07/2010
Date registered
9/07/2010
Date last updated
4/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Wellbeing Program2: An open trial of a brief internet based treatment of anxiety and depression
Scientific title
An open trial of a brief Internet based treatment for anxiety and depression
Secondary ID [1] 252171 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) 257714 0
Panic disorder (with or without agoraphobia) (both anxiety disorders) 257715 0
Generalised anxiety disorder (an anxiety disorder) 257716 0
Major depressive disorder (a depressive disorder) 257717 0
Condition category
Condition code
Mental Health 257882 257882 0 0
Anxiety
Mental Health 257883 257883 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an open trial where participants are allocated to recieve 8 week internet-based treatment. 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 5 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. 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 8 weeks, but participants 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] 256768 0
Treatment: Other
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258748 0
Anxiety is measured by the Generalised Anxiety Disorder 7 Item Scale (GAD-7)
Timepoint [1] 258748 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Primary outcome [2] 258749 0
Social phobia is measured by the Social Phobia Scale (SPS)
Timepoint [2] 258749 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Primary outcome [3] 258750 0
Social phobia is measured by the Social Interaction Anxiety Scale (SIAS)
Timepoint [3] 258750 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [1] 264797 0
Neuroticism is measured by using the NEO-Five Factor Inventory (NEO-FFI) Neuroticism scale
Timepoint [1] 264797 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [2] 264798 0
Disability is measured by the Sheehan Disability Scale (SDS)
Timepoint [2] 264798 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [3] 264799 0
Psychological distress is measured by the Kessler 10-item scale (K-10)
Timepoint [3] 264799 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [4] 264800 0
Panic disorder is measured by the Panic Disorder Severity Rating Scale - Self Report Version (PDSS-SR)
Timepoint [4] 264800 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [5] 264801 0
Generalised anxiety disorder is measured by the Penn State Worry Questionnaire (PSWQ)
Timepoint [5] 264801 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [6] 264802 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [6] 264802 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
Non-randomised 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).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/07/2010
Actual
5/07/2010
Date of last participant enrolment
Anticipated
Actual
5/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257263 0
Government body
Name [1] 257263 0
National Health and Medical Research Council (NHMRC)
Country [1] 257263 0
Australia
Primary sponsor type
University
Name
Clinical Research Unit for Anxiety and Depression (CRUfAD), School of Psychiatry, University of New South Wales
Address
CRUfAD, Level 4, O’Brien Center, 390 Victoria Street, Darlinghurst
NSW 2010, Australia
Country
Australia
Secondary sponsor category [1] 256507 0
Individual
Name [1] 256507 0
Dr Peter McEvoy
Address [1] 256507 0
Centre for Clinical Interventions (CCI) 223 James St Northbridge Western Australia 6003
Country [1] 256507 0
Australia
Other collaborator category [1] 251377 0
Individual
Name [1] 251377 0
Professor Michelle Craske
Address [1] 251377 0
Department of Psychology, University of California at Los Angeles (UCLA) 405 Hilgard Ave., Los Angeles, CA 90095-1563
Country [1] 251377 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259281 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 259281 0
Ethics committee country [1] 259281 0
Australia
Date submitted for ethics approval [1] 259281 0
Approval date [1] 259281 0
05/02/2010
Ethics approval number [1] 259281 0

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

Contacts
Principal investigator
Name 31373 0
Prof Nickolai Titov
Address 31373 0
Department of Psychology, Human Sciences, Macquarie University, Sydney, Australia
Country 31373 0
Australia
Phone 31373 0
+61 2 98509901
Fax 31373 0
Email 31373 0
[email protected]
Contact person for public queries
Name 14620 0
Dr Nickolai Titov
Address 14620 0
CRUfAD, Level 4, O’Brien Center, 390 Victoria Street, Darlinghurst
NSW 2010, Australia
Country 14620 0
Australia
Phone 14620 0
+61 2 8382 1732
Fax 14620 0
+61 2 8382 1721
Email 14620 0
[email protected]
Contact person for scientific queries
Name 5548 0
Dr Nickolai Titov
Address 5548 0
CRUfAD, Level 4, O’Brien Center, 390 Victoria Street, Darlinghurst
NSW 2010, Australia
Country 5548 0
Australia
Phone 5548 0
+61 2 8382 1732
Fax 5548 0
+61 2 8382 1721
Email 5548 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.