Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001055998
Ethics application status
Approved
Date submitted
15/09/2011
Date registered
10/10/2011
Date last updated
25/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Wellbeing6 Program for Anxiety and Depression - A Randomised Controlled Trial
Scientific title
A randomised controlled trial comparing clinician-assisted Internet based treatment for Generalised Anxiety Disorder (GAD) and/or depression vs. a waitlist control condition on severity of symptoms of GAD and depression.
Secondary ID [1] 263047 0
Nil
Universal Trial Number (UTN)
Trial acronym
The Wellbeing6 Program - A Randomised Controlled Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 270779 0
Generalised Anxiety Disorder 270780 0
Condition category
Condition code
Mental Health 270963 270963 0 0
Depression
Mental Health 270964 270964 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: 1) Treatment with clinician-assisted Internet based Cognitive Behavioural Therapy for Generalised Anxiety Disorder (GAD) and/or depression, or 2) Waitlist control. All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for GAD and/or Major Depressive Disorder. All group 1 participants will separately complete 6 lessons of Internet based treatment about the management of symptoms of GAD and depression. One lesson will be completed every 7 to 14 days (it will become available after the preceding lesson has been completed, with a minimum of 7 days between lessons and a maximum of 14 days). Each lesson will take about 15 minutes to complete. Group 1 participants will have access to summaries of each lesson, homework exercises, extra resources, weekly reminder emails, and one-on-one contact with the Clinician (Clinical Psychologist) by telephone or email in the first 2 weeks, then as required. The duration of the program is 8-10 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-treatment, mid-treatment, post-treatment, at 3 months post-treatment, and the K10 pre-each lesson. These will take about 20 minutes to complete. The treatment materials are based on cognitive behavioural techniques.
Intervention code [1] 269392 0
Other interventions
Intervention code [2] 269510 0
Behaviour
Comparator / control treatment
Waitlist control group. These participants remain on the waitlist until the treatment groups have completed their treatment (10 weeks). At that time (10 weeks) the waitlist group will receive the same treatment as Treatment Group 1.
Control group
Active

Outcomes
Primary outcome [1] 279629 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [1] 279629 0
Administered at application, pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Primary outcome [2] 279631 0
Generalised Anxiety Disorder is measured by the Generalized Anxiety Disorder - 7 Item (GAD-7) questionnaire.
Timepoint [2] 279631 0
Administered at application, pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [1] 294093 0
Psychological distress is measured by the Kessler-10 (K-10).
Timepoint [1] 294093 0
Administered before each lesson, at pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [2] 294094 0
Symptoms and severity of depression is measured by the Beck Depression Inventory - II (BDI-II).
Timepoint [2] 294094 0
Administered at pre-treatment and post-treatment.
Secondary outcome [3] 294096 0
Temperament is measured by the NEO-Five Factor Inventory, Neuroticism scale (NEO-FF-I, N scale).
Timepoint [3] 294096 0
Administered at pre-treatment and post-treatment.
Secondary outcome [4] 294097 0
Anxiety is also measured by the Penn State Worry Questionnaire (PSWQ).
Timepoint [4] 294097 0
Administered at pre-treatment and post-treatment.
Secondary outcome [5] 294098 0
Disability is measured by the WHO Disability Assessment Scale (WHODASS-II).
Timepoint [5] 294098 0
Administered at pre-treatment and post-treatment.
Secondary outcome [6] 294099 0
Rumination (or repetitive thinking) is measured by the Repetitive Thinking Questionnaire (RTF) and the Positive Beliefs about Rumination Scale-Adapted Version (PSRS-A).
Timepoint [6] 294099 0
Administered at pre-treatment and post-treatment.
Secondary outcome [7] 294102 0
Patient satisfaction questionnaire.
Timepoint [7] 294102 0
Administered at pre-treatment and post-treatment.
Secondary outcome [8] 294103 0
Adherence to lessons and homework.
Timepoint [8] 294103 0
Pre- each lesson (lesson must be completed and homework downloaded before patient advances to next lesson).

The slides of a lesson must be clicked through from start to finish before the homework for that lesson can be downloaded, and the next lesson will not become available until the homework has been downloaded. Our admin system will notify us whether or not the homework has been downloaded.

Eligibility
Key inclusion criteria
Meet Diagnostic and Statistical Manual of the American Psychiatric Association-4th Edition (DSM-IV) criteria for Generalised Anxiety Disorder and/or Major Depressive Disorder, Internet access + printer access, Australian citizen.
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 mental illness (Bipolar or Schizophrenia), Current or planned psychological treatment during study duration, Change in medications during last 1 month or intended change during study duration, use of Benzodiazepines, 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 on line, followed by a telephone interview to confirm diagnosis via the Mini-International Neuropsychiatric Interview (MINI 5.0.0), a structured diagnostic interview. Participants will be randomized using a list generated prior to the study. Allocation concealment will occur in the following way: A staff member not involved in the clinical trial will generate the sequence using computer software, and place each choice in a sequentially numbered, opaque, sealed and stapled envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation list will be generated prior to the study using computer software.
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
Completed
Date of first participant enrolment
Anticipated
10/10/2011
Actual
10/10/2011
Date of last participant enrolment
Anticipated
Actual
18/03/2012
Date of last data collection
Anticipated
Actual
18/09/2012
Sample size
Target
100
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 269858 0
Hospital
Name [1] 269858 0
St Vincent's Hospital, Sydney
Country [1] 269858 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 268882 0
None
Name [1] 268882 0
Address [1] 268882 0
Country [1] 268882 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271832 0
St Vincent's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 271832 0
Ethics committee country [1] 271832 0
Australia
Date submitted for ethics approval [1] 271832 0
Approval date [1] 271832 0
18/08/2011
Ethics approval number [1] 271832 0
11/SVH/95

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

Contacts
Principal investigator
Name 33161 0
Prof Professor Gavin Andrews
Address 33161 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 33161 0
Australia
Phone 33161 0
+612 8382 1400
Fax 33161 0
Email 33161 0
[email protected]
Contact person for public queries
Name 16408 0
Professor Gavin Andrews
Address 16408 0
St Vincent's Hospital, Sydney
390 Victoria St
Darlinghurst NSW 2010
Country 16408 0
Australia
Phone 16408 0
+612 8382 1400
Fax 16408 0
+612 8382 1401
Email 16408 0
[email protected]
Contact person for scientific queries
Name 7336 0
Professor Gavin Andrews
Address 7336 0
St Vincent's Hospital, Sydney
390 Victoria St
Darlinghurst NSW 2010
Country 7336 0
Australia
Phone 7336 0
+612 8382 1400
Fax 7336 0
+612 8382 1401
Email 7336 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.