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Trial registered on ANZCTR


Registration number
ACTRN12613001130752
Ethics application status
Approved
Date submitted
8/10/2013
Date registered
10/10/2013
Date last updated
25/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Bias Modification (CBM) and Obsessive Compulsive Beliefs
Scientific title
A randomised controlled trial comparing Internet based cognitive bias modification (Active version) for obsessive compulsive disorder vs. Internet based cognitive bias modification (Control version) on negative interpretation bias.
Secondary ID [1] 283374 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive compulsive disorder 290270 0
Condition category
Condition code
Mental Health 290659 290659 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Internet-based cognitive bias modification intervention with 4 sessions
(1 x 20 minute session/day) of written scenarios delivered over 1 week.

Each CBM session consists of delivery of 41 initially ambiguous scenarios that 100% of the time terminate with a positive resolution.

Adherence to the daily CBM sessions will be automatically tracked by the computer program. Standardised email reminders will be sent to a participant if more than 2 days lapse between logins.

Each of the 164 training scenarios is followed by a comprehension question to ascertain compliance with the training instructions.

Intervention code [1] 288101 0
Other interventions
Comparator / control treatment
Internet-based cognitive bias modification intervention with 4 sessions
(1 x 20 minute session/day) of written scenarios delivered over 1 week.

Each CBM session consists of delivery of 41 initially ambiguous scenarios that terminate 50% of the time with a positive resolution and 50% of the time with a negative resolution.


Adherence to the daily CBM sessions will be automatically tracked by the computer program. Standardised email reminders will be sent to a participant if more than 2 days lapse between logins.

Each of the 164 training scenarios is followed by a comprehension question to ascertain compliance with the training instructions.
Control group
Active

Outcomes
Primary outcome [1] 290678 0
Change in score on the OC Bias Measure
Timepoint [1] 290678 0
Administered at Baseline (T1), Post-CBM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).
Primary outcome [2] 290679 0
Change in score on the Ambiguous Scenarios Test for OCD (AST-OCD)
Timepoint [2] 290679 0
Administered at Baseline (T1), Post-CBM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).
Primary outcome [3] 290680 0
Change in score on the OBQ-TRIP
Timepoint [3] 290680 0
Administered at Baseline (T1), Post-CBM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).
Secondary outcome [1] 305020 0
Change in score on the Dimensional Obsessive-Compulsive Scale (DOCS)
Timepoint [1] 305020 0
Administered at Baseline (T1), Post-CBM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).
Secondary outcome [2] 305021 0
Change in score on the Patient Health Questionnaire (PHQ-9)
Timepoint [2] 305021 0
Administered at Baseline (T1), Post-CBM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).
Secondary outcome [3] 305022 0
Change in score on the Kessler-10 (K10) Psychological Distress Scale
Timepoint [3] 305022 0
Administered at Baseline (T1), Post-CBM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).
Secondary outcome [4] 305023 0
Change in score on the Word Sentence Association Test for OCD (WSAO)
Timepoint [4] 305023 0
Administered at Baseline (T1), Post-CBM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).
Secondary outcome [5] 305024 0
Treatment Expectancy and Outcomes Questionnaire
Timepoint [5] 305024 0
Administered at Baseline (T1), Post-CBM intervention (T2, 1 week after baseline), and at 1 month follow-up (T3).

Eligibility
Key inclusion criteria
Meet Lifetime diagnostic criteria for Obsessive Compulsive Disorder (DSM-IV and DSM 5 criteria will be assessed). Internet 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
Presence of severe depression and/or suicidal ideation;
lifetime psychotic symptoms or bipolar disorder; current substance abuse; current or planned psychological treatment during study
duration; change in medication during last 1 month or intended change during study duration, use of Benzodiazepines; not fluent in written and spoken English.

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), 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, opaque 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
Statistical methods / analysis
Sample size calculations were informed by effect sizes (ESs) reported in the most comparable study design (Clerkin & Teachman, 2011) of a moderate between-group ES of training on interpretive bias of Cohen’s d = .76.
We therefore estimated each condition to require a minimum of 22 participants per group (alpha = .05; power = .80), but at least 20% more will be recruited to hedge against potential data loss.


Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
14/10/2013
Actual
25/10/2013
Date of last participant enrolment
Anticipated
Actual
22/09/2014
Date of last data collection
Anticipated
Actual
24/10/2014
Sample size
Target
70
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288101 0
Hospital
Name [1] 288101 0
St Vincent's Hospital Sydney
Country [1] 288101 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria St Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 286821 0
University
Name [1] 286821 0
University of New South Wales
Address [1] 286821 0
Faculty of Medicine UNSW Sydney NSW 2052
Country [1] 286821 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290024 0
St. Vincent's Hospital HREC
Ethics committee address [1] 290024 0
St. Vincent's Hospital
394-404 Victoria St
Darlinghurst, 2010
NSW
Ethics committee country [1] 290024 0
Australia
Date submitted for ethics approval [1] 290024 0
Approval date [1] 290024 0
13/06/2013
Ethics approval number [1] 290024 0
13/123

Summary
Brief summary
This RCT will evaluate the acceptability and efficacy of a multi-day online CBM program targeting obsessive compulsive beliefs by comparing an active CBM
intervention with a control comparator.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43542 0
Dr Alishia Williams
Address 43542 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 43542 0
Australia
Phone 43542 0
+61283821434
Fax 43542 0
Email 43542 0
[email protected]
Contact person for public queries
Name 43543 0
Alishia Williams
Address 43543 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 43543 0
Australia
Phone 43543 0
+61283821434
Fax 43543 0
Email 43543 0
[email protected]
Contact person for scientific queries
Name 43544 0
Alishia Williams
Address 43544 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 43544 0
Australia
Phone 43544 0
+61283821434
Fax 43544 0
Email 43544 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
SourceTitleYear of PublicationDOI
Dimensions AIInternet-based cognitive bias modification for obsessive compulsive disorder: study protocol for a randomized controlled trial2014https://doi.org/10.1186/1745-6215-15-193
N.B. These documents automatically identified may not have been verified by the study sponsor.