Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000146998
Ethics application status
Approved
Date submitted
24/01/2020
Date registered
12/02/2020
Date last updated
28/09/2022
Date data sharing statement initially provided
12/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the effectiveness of a self-guided internet-administered cognitive behavioural treatment for obsessive-compulsive disorder
Scientific title
Exploring the effectiveness of a large self-guided internet-administered cognitive behavioural treatment for obsessive-compulsive disorder: A benchmarking study
Secondary ID [1] 300356 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive compulsive disorder 315969 0
Condition category
Condition code
Mental Health 314245 314245 0 0
Anxiety
Mental Health 314246 314246 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete 5 online lessons in 8 weeks. The online lessons take approximately 30 minutes to read through, with homework exercises taking a further hour per day. Participants are able to complete the lesson in their own time and participants are encouraged to log in to the site when a new lesson is available in order to complete the lesson.

The lessons are based on current best practice cognitive and behavioural techniques and include exposure and response prevention, and cognitive techniques. Exposure and response prevention involves gradually confronting feared situations whilst resisting the compulsive behaviours that would normally be used to reduce anxiety. The cognitive techniques are aimed at reducing the common cognitive biases seen in OCD and are aimed to help the participant to reduce their overestimation of threat and responsibility, reduce the need to control their thoughts and understand the misinterpretation of the meaning of these thoughts. The cognitive techniques also aim to help people to reduce their need for certainty and perfectionism.

Lessons are released according to a set timeline and participants are not able to read ahead of the timeline. This is a self-guided study and participants are not provided with any clinician support throughout the treatment. Adherence to the program (i.e., number of lessons completed, number of logins) is monitored in the system. To enhance treatment adherence participants will receive automated emails when a new lesson is released and when an available lesson has not been started by the participant.
Intervention code [1] 316634 0
Behaviour
Intervention code [2] 316720 0
Treatment: Other
Comparator / control treatment
This is an open trial. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322631 0
Yale Brown Obsessive Compulsive Scale
Timepoint [1] 322631 0
Baseline
Mid-treatment (5 weeks)
Post-education (8 weeks; primary endpoint)
3 month follow up
Secondary outcome [1] 379108 0
Dimensional Obsessive Compulsive Scale
Timepoint [1] 379108 0
Baseline
Mid-treatment (5 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [2] 379109 0
Patient Health Questionnaire - 9 item (PHQ-9)
Timepoint [2] 379109 0
Baseline
Mid-treatment (5 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [3] 379110 0
Clinical Global Impression (CGI) Scale
Timepoint [3] 379110 0
Baseline
Mid-treatment (5 weeks)
Post-treatment (8 weeks)
3 month follow up

Eligibility
Key inclusion criteria
(a) English speaking;
(b) 18 years of age or above;
(c) Have regular access to the internet;
(d) No suicidal plans or intention, or recent history of suicide attempts or deliberate self-harm;
(e) A score of at least 7 on one of the subscales of the Dimensional Obsessive Compulsive Scale (DOCS);
(f) A score of at least 14 on the Yale-Brown Obsessive Compulsive Scale (YBOCS).
(g) Meet criteria for OCD on the Diagnostic Interview for Anxiety, Mood, Obsessive-Compulsive, and other Neuropsychiatric Disorders (DIAMOND), administered in a self-report format.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Does not speak English;
(b) <18 years;
(c) Does not have regular access to the internet;
(d) Suicidal plans or intention, or recent history of suicide attempts or deliberate self-harm;
(e) Scored < 7 on all of the subscales of the Dimensional Obsessive Compulsive Scale (DOCS);
(f) Scored < 14 on the Yale-Brown Obsessive Compulsive Scale (YBOCS).
(g) Does not meet criteria for OCD based on the Diagnostic Interview for Anxiety, Mood, Obsessive-Compulsive, and other Neuropsychiatric Disorders (DIAMOND)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/02/2020
Actual
18/02/2020
Date of last participant enrolment
Anticipated
Actual
2/12/2021
Date of last data collection
Anticipated
5/06/2022
Actual
5/06/2022
Sample size
Target
300
Accrual to date
Final
324
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 22256 0
New Zealand
State/province [1] 22256 0
Country [2] 22257 0
United States of America
State/province [2] 22257 0
Country [3] 22258 0
Canada
State/province [3] 22258 0
Country [4] 22259 0
United Kingdom
State/province [4] 22259 0

Funding & Sponsors
Funding source category [1] 304779 0
Charities/Societies/Foundations
Name [1] 304779 0
International OCD Foundation
Country [1] 304779 0
United States of America
Primary sponsor type
University
Name
Macquarie University
Address
eCentreClinic
Centre for Emotional Health
Department of Psychology
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 305097 0
University
Name [1] 305097 0
University of Technology Sydney
Address [1] 305097 0
Graduate School of Health
Po Box 123
Broadway
NSW, 2007
Australia
Country [1] 305097 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305195 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 305195 0
Ethics committee country [1] 305195 0
Australia
Date submitted for ethics approval [1] 305195 0
Approval date [1] 305195 0
29/11/2019
Ethics approval number [1] 305195 0
52019274711156

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

Contacts
Principal investigator
Name 99566 0
A/Prof Blake Dear
Address 99566 0
Director eCentreClinic
Centre for Emotional Health
Department of Psychology
Macquarie University
NSW 2109
Country 99566 0
Australia
Phone 99566 0
+61 2 9850 9901
Fax 99566 0
Email 99566 0
[email protected]
Contact person for public queries
Name 99567 0
Bethany Wootton
Address 99567 0
Graduate School of Health
University of Technology Sydney
PO Box 123
Broadway
NSW, 2007
Country 99567 0
Australia
Phone 99567 0
+61 2 9514 3942
Fax 99567 0
Email 99567 0
[email protected]
Contact person for scientific queries
Name 99568 0
Bethany Wootton
Address 99568 0
Graduate School of Health
University of Technology Sydney
PO Box 123
Broadway
NSW, 2007
Country 99568 0
Australia
Phone 99568 0
+61 2 9514 3942
Fax 99568 0
Email 99568 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This has not been approved by our HREC


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.