Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000321943
Ethics application status
Approved
Date submitted
24/03/2011
Date registered
25/03/2011
Date last updated
25/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet-based cognitive-behavioural therapy for Obsessive-Compulsive Disorder
Scientific title
Evaluation of an internet-based cognitive-behavioural treatment program for Obsessive-Compulsive Disorder
Secondary ID [1] 259853 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive-Compulsive Disorder 265430 0
Condition category
Condition code
Mental Health 265590 265590 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a therapist-assisted, 12-week internet-based treatment adapted from a manualised face-to face CBT program (Systematic Treatment for Obsessive-compulsive Phenomena or STOP Therapy). OCD STOP consists of 12 modules where users complete one module per week for the duration of treatment. Each module takes approximately 1 hour to complete. Modules 1-3 provide information about OCD, anxiety, and an introduction to CBT, along with anxiety and depression management strategies (e.g., relaxation, activity scheduling). In Modules 4-6, Exposure and Response Prevention (ERP) strategies are introduced through the construction of hierarchies. These teach the participant to plan and implement an ERP program suited to their individual problem. Due to heterogeneity of the disorder, participants are provided with a range of examples to correspond to various presentations. Modules 7-9 include cognitive therapy techniques (e.g., cognitive restructuring) targeting OCD specific cognitive styles (such as inflated responsibility/overestimation of threat, importance/control of thoughts). As part of this, cognitive misappraisals are identified and alternatives developed and practiced; and more advanced ERP, integrating cognitive strategies is undertaken. Modules 10-12 include relapse preventions strategies (e.g., problem solving, risk identification, contingency management, and mindfulness techniques). The importance of daily practice is emphasised and discussions focus on enablers of and barriers to maintenance of CBT.

Therapist assistance for OCD STOP is in the form of weekly emails communication from a registered psychologist. All therapists will strictly adhere to the Australian Psychological Society Code of Ethics and the state registration board in providing online services.
Intervention code [1] 264270 0
Treatment: Other
Comparator / control treatment
This is a 12-week internet-based Progressive Relaxation Training for anxiety. Participants complete one module per week, which takes approximately 1 hour to complete. Individuals receive basic information about OCD, the relationship of OCD to anxiety, and the use of relaxation as a treatment for anxiety. Individuals are taught to relax specific muscle groups while paying attention to the feelings associated with both the tensed and relaxed stages. It permits the individual to achieve a state of deep relaxation in increasingly shorter periods and to control excess tension in stress-inducing situations. Participants work through the sequential tensing and releasing of 16 muscle groups (Modules 1 to 3). These are reduced to seven (Modules 4 and 5) and to four (Modules 6 to 7). The tension component is then withdrawn (Modules 8 to 11) in what is called “relaxation through recall,” and the final stage (Module 12) consists of a mental summary of the previously learned techniques. Participants will have access to downloadable audiovisual and written material on-site to guide their progressive relaxation training.

Upon completing the PRT and post-treatment measures, individuals will complete the therapist-assisted OCD STOP free of charge.
Control group
Active

Outcomes
Primary outcome [1] 262383 0
Primary Outcome 1: Mean Yale-Brown Obsessive-Compulsive Scale score
Timepoint [1] 262383 0
Baseline, and at 12 weeks, and at 6 months after intervention commencement
Primary outcome [2] 262384 0
Primary Outcome 2: Mean Hamilton Depression Rating Scale score
Timepoint [2] 262384 0
Baseline, and at 12 weeks, and at 6 months after intervention commencement
Primary outcome [3] 262385 0
Primary Outcome 3: Mean Hamilton Anxiety Rating Scale score
Timepoint [3] 262385 0
Baseline, and at 12 weeks, and at 6 months after intervention commencement
Secondary outcome [1] 273671 0
Secondary Outcome 1: Mean Australian Quality of Life Scale score
Timepoint [1] 273671 0
Baseline, and at 12 weeks, and at 6 months after intervention commencement
Secondary outcome [2] 273672 0
Secondary Outcome 2: Mean Revised Obsessional Beliefs Questionnaire score
Timepoint [2] 273672 0
Baseline, and at 12 weeks, and at 6 months after intervention commencement
Secondary outcome [3] 273673 0
Secondary Outcome 3: Mean Brief Disability Questionnaire scores
Timepoint [3] 273673 0
Baseline, and at 12 weeks, and at 6 months after intervention commencement
Secondary outcome [4] 273674 0
Secondary Outcome Measure 3: Mean Self-Ambivalence Measure score
Timepoint [4] 273674 0
Baseline, and at 12 weeks, and at 6 months after intervention commencement

Eligibility
Key inclusion criteria
Individuals must be 18 years or older and must reside in Australia.

Individuals with a primary diagnosis of OCD and/or secondary diagnoses with symptoms not in the severe range are considered to fulfil participation criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with psychotic symptoms, acute distress, or suicidal risk are considered ineligible for participation and will be referred for appropriate treatment to a mental health professional.

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)
Randomisation will be done via computer software and entered by an independent researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using computer software will be used to ensure that the number males/females is similar for the groups
independent researcher.
Masking / blinding
Blinded (masking 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
212
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3879 0
2000
Recruitment postcode(s) [2] 3880 0
3000
Recruitment postcode(s) [3] 3881 0
0800
Recruitment postcode(s) [4] 3882 0
4000
Recruitment postcode(s) [5] 3883 0
5000
Recruitment postcode(s) [6] 3884 0
6000
Recruitment postcode(s) [7] 3885 0
2600

Funding & Sponsors
Funding source category [1] 264730 0
Government body
Name [1] 264730 0
National Medical and Health Research Council
Country [1] 264730 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John Street
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 263857 0
None
Name [1] 263857 0
Address [1] 263857 0
Country [1] 263857 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266720 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 266720 0
Ethics committee country [1] 266720 0
Australia
Date submitted for ethics approval [1] 266720 0
Approval date [1] 266720 0
16/06/2010
Ethics approval number [1] 266720 0
SUHREC Project 2010/104

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

Contacts
Principal investigator
Name 32382 0
Address 32382 0
Country 32382 0
Phone 32382 0
Fax 32382 0
Email 32382 0
Contact person for public queries
Name 15629 0
Sam Mancuso
Address 15629 0
Swinburne University of Technology
PO Box 218 (Mail H99)
Hawthorn VIC 3122
Country 15629 0
Australia
Phone 15629 0
+61 3 9214 4628
Fax 15629 0
Email 15629 0
[email protected]
Contact person for scientific queries
Name 6557 0
Michael Kyrios
Address 6557 0
Swinburne University of Technology
PO Box 218 (Mail H99)
Hawthorn VIC 3122
Country 6557 0
Australia
Phone 6557 0
+61 3 9214 4886
Fax 6557 0
Email 6557 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.