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Trial registered on ANZCTR


Registration number
ACTRN12612001306808
Ethics application status
Approved
Date submitted
14/12/2012
Date registered
17/12/2012
Date last updated
25/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Obsessive Compulsive Disorder (OCD) Program - A Randomised Controlled Trial of online versus face-to-face Cognitive Behavioural Therapy (CBT)
Scientific title
A randomised controlled trial comparing clinician-assisted Internet based treatment for Obsessive Compulsive Disorder (OCD) vs. face to face treatment of OCD.
Secondary ID [1] 281686 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder (OCD) 287974 0
Condition category
Condition code
Mental Health 288356 288356 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two groups: 1) Treatment with clinician-assisted Internet based Cognitive Behavioural Therapy for Obsessive Compulsive Disorder (OCD), or 2) Face to face treatment for OCD at the Anxiety Disorders Clinic, St Vincent's Hospital, Sydney.

All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for OCD.

Group 1: The online treatment group will have 6 online lessons to complete over the 12 week period. We recommend approximately 1 hour per week reading the lessons (total approximately 12 hours). All group 1 participants will separately complete the Internet based treatment about the management of symptoms of OCD. One lesson will be completed every 7 to 14 days (it will become available after the preceding lesson has been completed, with a minimum of 7 days between lessons and a maximum of 14 days). Group 1 participants will have access to summaries of each lesson, homework exercises, extra resources, weekly reminder emails, and one-on-one contact with the Clinician (Clinical Psychologist) by telephone or email in the first 2 weeks, then as required. The duration of the program is 8-10 weeks, but participants will be contacted 3 months post program and asked to complete follow-up questionnaires.

Study questionnaires for both groups will be administered at application, pre-treatment, mid-treatment, post-treatment, at 3 months post-treatment, and the K10 pre-each lesson. These will take about 20 minutes to complete. The treatment materials are based on cognitive behavioural techniques.
Intervention code [1] 286222 0
Behaviour
Intervention code [2] 286223 0
Treatment: Other
Comparator / control treatment
Group 2: The face-to-face group will have 12, weekly one hour sessions (total 12 hours) at St Vincent’s Hospital, Sydney. Patients will be provided with a standardised Patient Treatment Manual and the clinical psychologist will guide participants through exercises designed to help patients gradually confront feared situations until their anxiety reduces.
Control group
Active

Outcomes
Primary outcome [1] 288524 0
Obsessive Beliefs Questionnaire (OBQ)
Timepoint [1] 288524 0
Administered at application, pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Primary outcome [2] 288525 0
Dimensional Obsessive Compulsive Scale (DOCS)
Timepoint [2] 288525 0
Administered at application, pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [1] 300388 0
Psychological distress is measured by the Kessler-10 (K-10).
Timepoint [1] 300388 0
Administered before each lesson, at pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [2] 300389 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [2] 300389 0
Administered at pre-treatment and post-treatment.
Secondary outcome [3] 300390 0
Generalised Anxiety Disorder is measured by the Generalized Anxiety Disorder - 7 Item (GAD-7) questionnaire.
Timepoint [3] 300390 0
Administered at pre-treatment and post-treatment.
Secondary outcome [4] 300391 0
Sheehan Disability Scale (SDS)
Timepoint [4] 300391 0
Administered at pre-treatment and post-treatment.
Secondary outcome [5] 300392 0
Credibility/Expectancy Questionnaire (CEQ)
Timepoint [5] 300392 0
Administered at pre-treatment and post-treatment.
Secondary outcome [6] 300393 0
Adherence to lessons and homework.
Timepoint [6] 300393 0
Before each lesson (lesson must be completed and homework downloaded before patient advances to next lesson). The slides of a lesson must be clicked through from start to finish before the homework for that lesson can be downloaded, and the next lesson will not become available until the homework has been downloaded. Our admin system will notify us whether or not the homework has been downloaded.
For face-to-face patients this will be assessed in each session.

Eligibility
Key inclusion criteria
Meet Diagnostic and Statistical Manual of the American Psychiatric Association-4th Edition (DSM-IV) criteria for Obsessive Compulsive Disorder, Internet access + printer access, Australian citizen, can access face-to-face sessions in Sydney for 12 weeks and referred to the Anxiety Disorders Clinic, St Vincent's Hospital, Sydney.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current substance abuse/dependence, Psychotic mental illness (Bipolar or Schizophrenia), Current or planned psychological treatment during study duration, previous iCBT for OCD, Change in medications during last 1 month or intended change during study duration, use of Benzodiazepines, Suicidal.

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)
There are already people on the waitlist for the Anxiety Disorders Clinic at St Vincent's Hospital, Sydney. When people attend the Anxiety Disorders Clinic, they will be offered participation in the study. People will read the information about the study and elect to continue or not. If they choose to apply for the study they will undergo a brief phone interview with a clinician from the program explaining the program, will read the information sheet and return an electronic consent form to the investigators. The phone interview will continue in which the diagnosis will be confirmed using the Mini International Neuropsychiatric Interview Version 5.0.0 (Appendix A). Questions about the study will be answered and an offer of treatment made. Patients will be randomly allocated to CaCCBT group (n=25), or face-to-face cognitive behaviour therapy (n=25). Randomisation will be done via www.random.org and allocation will be concealed (in opaque sealed envelopes) until the offer of treatment is made and accepted.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sequence will be generated on www.random.org
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be undertaken using mixed-model repeated measures (MMRM) ANOVA with measurement occasion as a within-groups factor and intervention as a between-groups factor. Relationships between observations at different occasions will be modelled with an unstructured covariance matrix. For each experimental group, planned contrasts will be used to compare changes from baseline to post-test and 3 month follow-up.

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
2/01/2013
Actual
2/01/2013
Date of last participant enrolment
Anticipated
1/12/2015
Actual
30/09/2013
Date of last data collection
Anticipated
Actual
30/09/2013
Sample size
Target
50
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 322 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 6127 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 286476 0
Hospital
Name [1] 286476 0
St Vincent's Hospital, Sydney
Country [1] 286476 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 285267 0
None
Name [1] 285267 0
Address [1] 285267 0
Country [1] 285267 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288554 0
St Vincent's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 288554 0
St Vincent's Hospital HREC 390 Victoria Street Darlinghurst NSW 2010
Ethics committee country [1] 288554 0
Australia
Date submitted for ethics approval [1] 288554 0
Approval date [1] 288554 0
04/12/2012
Ethics approval number [1] 288554 0
HREC/12/SVH/299

Summary
Brief summary
The purpose is to investigate the value of a new internet therapy for people troubled by OCD compared to participants who receive face-to-face clinician-delivered cognitive behavioural therapy (CBT). We hypothesise there will be no difference in treatment outcomes between the groups.
Trial website
www.virtualclinic.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36658 0
Prof Gavin Andrews
Address 36658 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 36658 0
Australia
Phone 36658 0
+612 8382 1400
Fax 36658 0
Email 36658 0
[email protected]
Contact person for public queries
Name 36659 0
Gavin Andrews
Address 36659 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 36659 0
Australia
Phone 36659 0
+612 8382 1400
Fax 36659 0
Email 36659 0
[email protected]
Contact person for scientific queries
Name 36660 0
Gavin Andrews
Address 36660 0
St Vincent's Hospital, Sydney 390 Victoria St Darlinghurst NSW 2010
Country 36660 0
Australia
Phone 36660 0
+612 8382 1400
Fax 36660 0
Email 36660 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

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