Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000954820
Ethics application status
Approved
Date submitted
4/09/2012
Date registered
6/09/2012
Date last updated
2/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An open trial of unguided internet delivered cognitive-behavioural therapy for obsessive-compulsive disorder (OCD): A replication and extension
Scientific title
An open trial of a self-guided internet-delivered CBT treatment program for adults with obsessive-compulsive disorder: A replication and extension
Secondary ID [1] 281145 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obsessive compulsive disorder 287313 0
Condition category
Condition code
Mental Health 287653 287653 0 0
Anxiety
Mental Health 287654 287654 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete 6 online lessons in 10 weeks. The online lessons take approximately 30 minutes to read through, with homework exercises taking a further hour per day. 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.
Intervention code [1] 285602 0
Behaviour
Comparator / control treatment
This is an open trial. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287900 0
Yale Brown Obsessive Compulsive Scale
Timepoint [1] 287900 0
Baseline
Weekly
Post-education (10 weeks)
3 month follow up
12 month follow up
Primary outcome [2] 287901 0
Dimensional Obsessive Compulsive Scale
Timepoint [2] 287901 0
Baseline
Weekly
Post-education (10 weeks)
3 month follow up
12 month follow up
Secondary outcome [1] 299026 0
Patient Health Questionnaire - 9 item (PHQ-9)
Timepoint [1] 299026 0
Baseline
Weekly
Post-education (10 weeks)
3 month follow up
12 month follow up

Eligibility
Key inclusion criteria
An Australian resident
Aged 18-65 years
Have access to a computer with internet access
Elevated symptoms of obsessive-compulsive disorder (score equal to or greater than 16 on the total YBOCS or 10 or more on either the obsessions or compulsions subscale).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of or current Psychosis/mania
Current Suicidal plans or severe depression
Score less than 16 on the YBOCS

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)
Participants will be recruited via the eCentreClinic website (www.ecentreclinic.org) and undergo screening online. If participants meet all inclusion/exclusion criteria they are allocated to the treatment group and notified via email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a non randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2012
Actual
10/09/2012
Date of last participant enrolment
Anticipated
Actual
9/02/2013
Date of last data collection
Anticipated
Actual
30/07/2013
Sample size
Target
40
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 285927 0
University
Name [1] 285927 0
Macquarie University
Country [1] 285927 0
Australia
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] 284748 0
None
Name [1] 284748 0
None
Address [1] 284748 0
Country [1] 284748 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287954 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 287954 0
Macquarie University
NSW 2109
Ethics committee country [1] 287954 0
Australia
Date submitted for ethics approval [1] 287954 0
Approval date [1] 287954 0
30/08/2012
Ethics approval number [1] 287954 0
5201200553

Summary
Brief summary
By conducting this project we hope to explore the short and long term benefits of a self-guided treatment for obsessive-compulsive disorder. We also hope to find out how acceptable the program is to consumers and how we can improve the program. The results will inform us about who is likely to benefit from this treatment protocol and how best to administer this program.
Trial website
http://www.ecentreclinic.org/index.php/our-courses/ocd
Trial related presentations / publications
Wootton, B.M., Dear, B.F., Titov, N., Johnston, L., & Terides, M. (2014). Self-guided internet administered treatment for obsessive-compulsive disorder: Results from two open trials. Journal of Obsessive Compulsive and Related Disorders. 3(2): 102-108.
Public notes

Contacts
Principal investigator
Name 34656 0
A/Prof Nick Titov
Address 34656 0
Director eCentreClinic Centre for Emotional Health Department of Psychology Macquarie University NSW 2109
Country 34656 0
Australia
Phone 34656 0
+61 2 9850 9901
Fax 34656 0
Email 34656 0
[email protected]
Contact person for public queries
Name 17903 0
Dr Bethany Wootton
Address 17903 0
Department of Psychology
University of Tasmania
Locked Bag 30
Hobart, TAS, 7001
Country 17903 0
Australia
Phone 17903 0
+61 3 6226 7124
Fax 17903 0
Email 17903 0
[email protected]
Contact person for scientific queries
Name 8831 0
A/Prof Nick Titov
Address 8831 0
Director
eCentreClinic
Centre for Emotional Health
Department of Psychology
Macquarie University
NSW 2109
Country 8831 0
Australia
Phone 8831 0
+61 2 9850 9901
Fax 8831 0
Email 8831 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.