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Trial registered on ANZCTR


Registration number
ACTRN12612001073897
Ethics application status
Approved
Date submitted
5/10/2012
Date registered
8/10/2012
Date last updated
23/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Obsessive Compulsive Disorder (OCD) Program - A Randomised Controlled Trial comparing clinician-assisted Internet based treatment for OCD vs. a waitlist control condition on severity of symptoms of OCD.
Scientific title
A randomised controlled trial comparing clinician-assisted Internet based treatment for Obsessive Compulsive Disorder (OCD) vs. a waitlist control condition on severity of symptoms of OCD.
Secondary ID [1] 281351 0
Nil
Universal Trial Number (UTN)
Trial acronym
The OCD Program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder 287573 0
Condition category
Condition code
Mental Health 287898 287898 0 0
Other mental health disorders

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) Waitlist control. All participants will meet Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for OCD. All group 1 participants will separately complete 6 lessons of 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). Each lesson will take about 15 minutes to complete. 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 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] 285811 0
Treatment: Other
Intervention code [2] 285812 0
Behaviour
Comparator / control treatment
Waitlist control group. These participants remain on the waitlist until the treatment groups have completed their treatment (10 weeks). At that time (10 weeks) the waitlist group will receive the same treatment as Treatment Group 1.
Control group
Active

Outcomes
Primary outcome [1] 288113 0
Obsessive Beliefs Questionnaire (OBQ)
Timepoint [1] 288113 0
Administered at application, pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Primary outcome [2] 288114 0
Dimensional Obsessive Compulsive Scale (DOCS)
Timepoint [2] 288114 0
Administered at application, pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [1] 299447 0
Psychological distress is measured by the Kessler-10 (K-10).
Timepoint [1] 299447 0
Administered before each lesson, at pre-treatment, mid-treatment, post-treatment, and at 3 months post-treatment.
Secondary outcome [2] 299448 0
Symptoms and severity of depression is measured by the Patient Health Questionnaire-9 (PHQ-9).
Timepoint [2] 299448 0
Administered at pre-treatment and post-treatment.
Secondary outcome [3] 299449 0
Generalised Anxiety Disorder is measured by the Generalized Anxiety Disorder - 7 Item (GAD-7) questionnaire.
Timepoint [3] 299449 0
Administered at pre-treatment and post-treatment.
Secondary outcome [4] 299450 0
Sheehan Disability Scale (SDS)
Timepoint [4] 299450 0
Administered at pre-treatment and post-treatment.
Secondary outcome [5] 299451 0
Credibility/Expectancy Questionnaire (CEQ)
Timepoint [5] 299451 0
Administered at pre-treatment and post-treatment.
Secondary outcome [6] 299452 0
Adherence to lessons and homework.
Timepoint [6] 299452 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.

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.
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)
Participants apply on line, followed by a telephone interview to confirm diagnosis via the Mini-International Neuropsychiatric Interview (MINI 5.0.0), a structured diagnostic interview. Participants will be randomized using a list generated prior to the study. Allocation concealment will occur in the following way: A staff member not involved in the clinical trial will generate the sequence using computer software, and place each choice in a sequentially numbered, opaque, sealed and stapled envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation list will be generated prior to the study using computer software.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/10/2012
Actual
11/10/2012
Date of last participant enrolment
Anticipated
Actual
4/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 286110 0
Hospital
Name [1] 286110 0
St Vincent's Hospital, Sydney
Country [1] 286110 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] 284922 0
None
Name [1] 284922 0
Address [1] 284922 0
Country [1] 284922 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288157 0
St Vincent's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 288157 0
Ethics committee country [1] 288157 0
Australia
Date submitted for ethics approval [1] 288157 0
Approval date [1] 288157 0
05/10/2012
Ethics approval number [1] 288157 0
12/SVH/239

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

Contacts
Principal investigator
Name 34794 0
Prof Gavin Andrews
Address 34794 0
Level 4, O'Brien Centre
390-394 Victoria Street
St Vincent's Hospital
Darlinghurst
NSW
2010
Country 34794 0
Australia
Phone 34794 0
+612 8382 1400
Fax 34794 0
Email 34794 0
[email protected]
Contact person for public queries
Name 18041 0
Professor Gavin Andrews
Address 18041 0
St Vincent's Hospital, Sydney
390 Victoria St
Darlinghurst NSW 2010
Country 18041 0
Australia
Phone 18041 0
+612 8382 1400
Fax 18041 0
+612 8382 1401
Email 18041 0
[email protected]
Contact person for scientific queries
Name 8969 0
Professor Gavin Andrews
Address 8969 0
St Vincent's Hospital, Sydney
390 Victoria St
Darlinghurst NSW 2010
Country 8969 0
Australia
Phone 8969 0
+612 8382 1400
Fax 8969 0
+612 8382 1401
Email 8969 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.