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Trial registered on ANZCTR


Registration number
ACTRN12613000139774
Ethics application status
Approved
Date submitted
4/02/2013
Date registered
5/02/2013
Date last updated
25/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of two different versions of Cognitive Bias Modification (CBM) plus Internet Cognitive Behavioural Therapy (iCBT) for Depression- A Randomised Controlled Trial
Scientific title
A randomised controlled trial comparing Internet based cognitive behavioural therapy for major depressive disorder plus a cognitive bias modification intervention (OxIGen) version A vs. Internet based cognitive behavioural therapy for major depressive disorder plus a cognitive bias modification intervention (OxIGen) version B on symptoms of depression and negative interpretation bias.
Secondary ID [1] 281893 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 288292 0
Condition category
Condition code
Mental Health 288636 288636 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CBM (OxIGen) Active Version:
Internet-based cognitive bias modification intervention with 7 sessions (1 x 20 minute session/day) of auditory scenarios delivered over 1 week. Each CBM session consists of delivery of 64 initially ambiguous scenarios that terminate with a positive resolution.

+ ThisWayUp Sadness Program: a 6-lesson internet-based cognitive behavioural therapy program for depression. The Sadness Program includes evidence-based content for managing depression and anxiety. Each lesson (approximately 30 minutes) must be completed prior to advancing to the subsequent lesson. Patients are given 8 weeks to complete all 6 lessons.

Patients first commence the 1 week CBM component followed by the 8 week iCBT component.
Intervention code [1] 286457 0
Treatment: Other
Intervention code [2] 286464 0
Behaviour
Comparator / control treatment
CBM (OxIGen) Control Version ( identical to CBM active, but with putative active components removed):
Internet-based cognitive bias modification intervention with 7 sessions (1 x 20 minute session/day) of auditory scenarios delivered over 1 week. Each CBM session consists of delivery of 64 initially ambiguous scenarios that terminate 50% of the time with a positive resolution and 50% of the time with a negative resolution.

+ ThisWayUp Sadness Program: a 6-lesson internet-based cognitive behavioural therapy program for depression. The Sadness Program includes evidence-based content for managing depression and anxiety. Each lesson (approximately 30 minutes) must be completed prior to advancing to the subsequent lesson. Patients are given 8 weeks to complete all 6 lessons.

Patients first commence the 1 week CBM component followed by the 8 week iCBT component.
Control group
Active

Outcomes
Primary outcome [1] 288790 0
Change in score on the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [1] 288790 0
Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Primary outcome [2] 288791 0
Change in score on the Beck Depression Inventory - second edition (BDI-II).
Timepoint [2] 288791 0
Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Primary outcome [3] 288792 0
Change on the Ambiguous Sentence Task (AST).
Timepoint [3] 288792 0
Administered at baseline (T1) and post-CBM intervention (T2, 1 week after baseline).
Secondary outcome [1] 300994 0
Change in distress on the Kessler-10.
Timepoint [1] 300994 0
Administered at baseline (T1), post-CBM intervention (T2, 1 week after baseline), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up.
Secondary outcome [2] 300995 0
Change on WHO Disability Assessment Scale (WHO-DAS).
Timepoint [2] 300995 0
Administered at baseline (T1) post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Secondary outcome [3] 300996 0
Change on the Repetitive Thinking Questionnaire (RTQ).
Timepoint [3] 300996 0
Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Secondary outcome [4] 300997 0
Change on the State Trait Anxiety Inventory (STAI).
Timepoint [4] 300997 0
Administered at baseline (T1) post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Secondary outcome [5] 300998 0
Change in score on the Clinical Perfectionism Scale (CPS).
Timepoint [5] 300998 0
Administered at baseline (T1), post iCBT intervention (8-10 weeks after baseline), and at 3 month follow-up (T4).
Secondary outcome [6] 300999 0
Change in diagnostic status on the MINI Depression Module
Timepoint [6] 300999 0
Administered at baseline (T1) and 3-month follow-up (T4).

Eligibility
Key inclusion criteria
Meet Diagnostic and Statistical Manual of the American Psychiatric Association - 4th edition (DSM-IV) criteria for Major Depressive Disorder, Internet access + printer access, Australian resident, Fluent in written and spoken English.
Minimum age
18 Years
Maximum age
65 Years
Gender
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 medication 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 online, followed by a telephone interview to confirm diagnosis via the Mini-International Neuropsychiatric Interview (MINI 5.0.0), a structured clinical interview.
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.
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, sealed and stapled envelope.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 286676 0
Hospital
Name [1] 286676 0
St Vincent's Hospital Sydney
Address [1] 286676 0
390 Victoria St Darlinghurst NSW 2010
Country [1] 286676 0
Australia
Funding source category [2] 286677 0
University
Name [2] 286677 0
CRUfAD Departmental funds
Address [2] 286677 0
University of New South Wales
High St, Kensington NSW 2052
Country [2] 286677 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria St Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 285451 0
University
Name [1] 285451 0
University of New South Wales
Address [1] 285451 0
Faculty of Medicine UNSW Sydney NSW 2052
Country [1] 285451 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288745 0
St. Vincent's Hospital HREC
Ethics committee address [1] 288745 0
St. Vincent's Hospital
394-404 Victoria St
Darlinghurst, 2010
NSW
Ethics committee country [1] 288745 0
Australia
Date submitted for ethics approval [1] 288745 0
Approval date [1] 288745 0
31/01/2013
Ethics approval number [1] 288745 0
HREC/12/SVH/326

Summary
Brief summary
This RCT will evaluate the acceptability and efficacy of a combined CBM + internet-based CBT program for depression by comparing an active CBM intervention with a control comparator.
Trial website
Trial related presentations / publications
Williams, A.D., O'Moore, K., Blackwell, S., Smith, J., Holmes, E.A., Andrews, G (2015). Positive imagery cognitive bias modification (CBM) and internet-based cognitive behavioral therapy (iCBT): A randomized controlled tria. Journal of Affective Disorders
Public notes

Contacts
Principal investigator
Name 37622 0
Prof Gavin Andrews
Address 37622 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 37622 0
Australia
Phone 37622 0
+61283821405
Fax 37622 0
Email 37622 0
gavina@unsw.edu.au
Contact person for public queries
Name 37623 0
Dr Alishia Williams
Address 37623 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 37623 0
Australia
Phone 37623 0
+61283821434
Fax 37623 0
Email 37623 0
alishia.williams@unsw.edu.au
Contact person for scientific queries
Name 37624 0
Dr Alishia Williams
Address 37624 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 37624 0
Australia
Phone 37624 0
+61283821434
Fax 37624 0
Email 37624 0
alishia.williams@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary