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Trial registered on ANZCTR


Registration number
ACTRN12611001221943
Ethics application status
Approved
Date submitted
28/11/2011
Date registered
29/11/2011
Date last updated
25/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Bias Modification (CBM) and 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) vs. Internet based cognitive behavioural therapy for major depressive disorder vs. a waitlist control on symptoms of depression and negative interpretation bias.
Secondary ID [1] 273471 0
Nil
Universal Trial Number (UTN)
Trial acronym
CBM and iCBT for Depression - A Randomised Controlled Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 279261 0
Condition category
Condition code
Mental Health 279459 279459 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be assigned to one of two groups: 1) CBM intervention (OxIGen) plus Internet based Cognitive Behavioural Therapy (iCBT) for depression, or 2) Waitlist control.
All participants will meet Diagnostic and Statistical Manual for Mental Disorders 4th edition (DSM-IV) criteria for Major Depressive Disorder. Group 1 participants will first complete a 1 week online computer CBM program, called OxIGen (Oxford Imagery Generation). The OxIGen program consists of a series of auditory stimuli that Group 1 participants will listen to and make ratings in response to. Group 1 participants will login 1 time per day for a period of 7 consecutive days to complete a new module. Each module will take between 13-20 minutes to complete. Group 1 and participants will then complete 6 lessons of Internet based treatment about the management of symptoms of depression. One lesson will be completed every 7-14 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 approximately 15 minutes to complete. Group 1 participants will have access to summaries of each lesson, homework exercises, extra resources, weekly reminder emails, and contact with a Clinician as required. The duration of the program will be 8-10 weeks. Group 2 participants will receive the same iCBT treatment as Group 2 (without the additional Oxigen Program) after 11 weeks.
Intervention code [1] 283788 0
Behaviour
Intervention code [2] 283796 0
Other interventions
Comparator / control treatment
Waitlist control group. These participants remain on the waitlist until Group 1 has completed treatment (11 weeks). At that time (11 weeks) the waitlist group will receive iCBT.
Control group
Active

Outcomes
Primary outcome [1] 286019 0
Change in score on the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [1] 286019 0
Administered at application, pre-intervention (Group 1 OxIGen), post-intervention (Group 1 OxIGen)/pre-treatment (iCBT), mid-treatment (iCBT), post-treatment (iCBT).
Primary outcome [2] 286020 0
Change in score on the Beck Depression Inventory - second edition (BDI-II).
Timepoint [2] 286020 0
Administered at pre-intervention (Group 1 OxIGen), post-intervention (Group 1 OxIGen)/pre-treatment (iCBT), mid-treatment (iCBT), post-treatment (iCBT).
Secondary outcome [1] 295001 0
Change on the Scrambled Sentences Task (SST)- electronic version.
Timepoint [1] 295001 0
Administered at pre-intervention (Group 1 OxIGen), post-intervention (Group 1 OxIGen).
Secondary outcome [2] 295002 0
Change on Prospective Imagery Test (PIT)
Timepoint [2] 295002 0
Administered at pre-intervention (Group 1 OxIGen), post-intervention (Group 1 OxIGen).
Secondary outcome [3] 295003 0
Change in distress on the Kessler-10 (K10).
Timepoint [3] 295003 0
Administered at pre-intervention (Group 1 OxIGen), post-intervention (Group 1 OxIGen)/pre-treatment (iCBT), before each iCBT lesson, post-treatment (iCBT).
Secondary outcome [4] 295004 0
Change on WHO Disability Assessment Scale (WHO-DAS).
Timepoint [4] 295004 0
Administered at pre-intervention/treatment and post-treatment.
Secondary outcome [5] 295005 0
Change on the Repetitive Thinking Questionnaire (RTQ)
Timepoint [5] 295005 0
Administered at pre-intervention/treatment and post-treatment.
Secondary outcome [6] 295006 0
Change on the State Trait Anxiety Inventory (STAI).
Timepoint [6] 295006 0
Administered at pre-intervention/treatment and post-treatment.
Secondary outcome [7] 295007 0
Change on the Ambiguous Sentence Task (AST).
Timepoint [7] 295007 0
Administered at pre-intervention and post-intervention.

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
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 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. 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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization 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
1/12/2011
Actual
6/12/2011
Date of last participant enrolment
Anticipated
Actual
28/03/2012
Date of last data collection
Anticipated
Actual
28/09/2012
Sample size
Target
153
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 284265 0
Hospital
Name [1] 284265 0
St Vincent's Hospital Sydney
Country [1] 284265 0
Australia
Funding source category [2] 284270 0
University
Name [2] 284270 0
UNSW
Country [2] 284270 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria St
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 283217 0
University
Name [1] 283217 0
The University of New South Wales
Address [1] 283217 0
UNSW Sydney NSW 2052
Country [1] 283217 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286225 0
St Vincent's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 286225 0
Ethics committee country [1] 286225 0
Australia
Date submitted for ethics approval [1] 286225 0
19/05/2011
Approval date [1] 286225 0
31/10/2011
Ethics approval number [1] 286225 0
1/11/0055

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

Contacts
Principal investigator
Name 33441 0
Prof Gavin Andrews
Address 33441 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 33441 0
Australia
Phone 33441 0
+61283821400
Fax 33441 0
Email 33441 0
gavina@unsw.edu.au
Contact person for public queries
Name 16688 0
Professor Gavin Andrews
Address 16688 0
St Vincent's Hospital, Sydney
390 Victoria St
Darlinghurst NSW 2010
Country 16688 0
Australia
Phone 16688 0
+61283821400
Fax 16688 0
+61283821401
Email 16688 0
gavina@unsw.edu.au
Contact person for scientific queries
Name 7616 0
Professor Gavin Andrews
Address 7616 0
St Vincent's Hospital, Sydney
390 Victoria St
Darlinghurst NSW 2010
Country 7616 0
Australia
Phone 7616 0
+61283821400
Fax 7616 0
+61283821401
Email 7616 0
gavina@unsw.edu.au

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.