Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000521820
Ethics application status
Approved
Date submitted
16/05/2012
Date registered
16/05/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An open trial of a self-guided internet-delivered treatment program for obsessive-compulsive disorder
Scientific title
An open trial of a self-guided internet-delivered CBT treatment program for adults with obsessive-compulsive disorder
Secondary ID [1] 280482 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obsessive compulsive disorder 286462 0
Condition category
Condition code
Mental Health 286719 286719 0 0
Anxiety
Mental Health 286734 286734 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete 6 online lessons in 8 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] 284849 0
Behaviour
Comparator / control treatment
This is an open trial. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287116 0
Yale Brown Obsessive Compulsive Scale
Timepoint [1] 287116 0
Baseline
Weekly
Post-education (8 weeks)
3 month follow up
Primary outcome [2] 287117 0
Dimensional Obsessive Compulsive Scale
Timepoint [2] 287117 0
Baseline
Mid-treatment (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [1] 297417 0
Patient Health Questionnaire - 9 item (PHQ-9)
Timepoint [1] 297417 0
Baseline
Weekly
Post-education (8 weeks)
3 month follow up
Secondary outcome [2] 297452 0
Acceptability Questionnaire - This questionnaire has been developed specifically for this study
Timepoint [2] 297452 0
Post-education (8 weeks)

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?
Yes
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
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
14/05/2012
Actual
9/09/2012
Date of last participant enrolment
Anticipated
Actual
9/02/2013
Date of last data collection
Anticipated
Actual
9/04/2014
Sample size
Target
40
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 285240 0
University
Name [1] 285240 0
Macquarie University
Country [1] 285240 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] 284105 0
None
Name [1] 284105 0
Address [1] 284105 0
Country [1] 284105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287248 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 287248 0
Macquarie University
NSW 2109
Ethics committee country [1] 287248 0
Australia
Date submitted for ethics approval [1] 287248 0
Approval date [1] 287248 0
Ethics approval number [1] 287248 0
5201100547

Summary
Brief summary
The aim of this study is to evaluate the use of a self-guided internet treatment program for OCD. It is hypothesized that: 1. The treatment group will show significant improvement on primary measures of OCD symptoms relative to baseline and 2. The treatment will be deemed as acceptable by participants
Trial website
http://www.ecentreclinic.org/index.php/our-courses/ocd
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34173 0
Prof Nick Titov
Address 34173 0
Director eCentreClinic Centre for Emotional Health Department of Psychology Macquarie University NSW 2109
Country 34173 0
Australia
Phone 34173 0
+61 2 9850 9901
Fax 34173 0
Email 34173 0
[email protected]
Contact person for public queries
Name 17420 0
Dr Bethany Wootton
Address 17420 0
Graduate School of Health
University of Technology Sydney
Po Box 123
Broadway
NSW 2007
Country 17420 0
Australia
Phone 17420 0
+61 2 9514 3942
Fax 17420 0
Email 17420 0
[email protected]
Contact person for scientific queries
Name 8348 0
Prof Nick Titov
Address 8348 0
Director
eCentreClinic
Centre for Emotional Health
Department of Psychology
Macquarie University
NSW 2109
Country 8348 0
Australia
Phone 8348 0
+61 2 9850 9901
Fax 8348 0
+61 2 9850 8062
Email 8348 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.