Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000116921
Ethics application status
Approved
Date submitted
27/01/2011
Date registered
1/02/2011
Date last updated
2/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of a clinician-guided education program for Obsessive Compulsive Disorder comparing the efficacy of administration via the Internet with administration via Bibliotherapy
Scientific title
A randomised controlled trial of a clinician-guided education program for Obsessive Compulsive Disorder comparing the efficacy of administration via the Internet with administration via Bibliotherapy
Secondary ID [1] 253490 0
Nil
Universal Trial Number (UTN)
Trial acronym
The OCD Program: RCT 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive compulsive disorder 261039 0
Condition category
Condition code
Mental Health 259180 259180 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the treatment groups will complete 5 lessons in 8 weeks of a guided program for OCD. The internet group will complete these lessons online, the bibliotherapy group will complete these lessons from a hard copy self help workbook. Both groups receive the same information. The lessons for both groups 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. The participant is phoned twice weekly by a clinical psychologist (these days are determined by the participant) and may also be contacted at other times by the participant by email or phone. A printable information summary will also be provided, and some homework assignments will be set
Intervention code [1] 257923 0
Behaviour
Intervention code [2] 257924 0
Treatment: Other
Comparator / control treatment
The waitlist control group receive their choice of the two methods of administration (Internet or Bibliotherapy) with weekly contact from a clinical psychologist once the other groups have completed the program (week 9).
Control group
Active

Outcomes
Primary outcome [1] 262029 0
Yale Brown Obsessive Compulsive Disorder Scale (YBOCS)
Timepoint [1] 262029 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Primary outcome [2] 262030 0
Obsessive Compulsive Inventory (OCI)
Timepoint [2] 262030 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Primary outcome [3] 262031 0
Obsessive Beliefs Questionnaire (OBQ)
Timepoint [3] 262031 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [1] 268991 0
Sheehan Disability Scale (SDS)
Timepoint [1] 268991 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [2] 268992 0
Kessler - 10 (K-10)
Timepoint [2] 268992 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [3] 268993 0
Patient Health Questionnaire (PHQ-9)
Timepoint [3] 268993 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [4] 268994 0
Generalised Anxiety Disorder - 7 Item (GAD- 7)
Timepoint [4] 268994 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [5] 268995 0
Treatment Expectancy Questionnaire
Timepoint [5] 268995 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [6] 268996 0
OCD Diagnosis via Structured Interview - Mini International Neuropsychiatric Interview (MINI)
Timepoint [6] 268996 0
Baseline
Post-education (8 weeks)
3 month follow up

Eligibility
Key inclusion criteria
An Australian resident
Aged 18-79 years
Have access to a computer with internet access
Primary diagnosis of obsessive compulsive disorder
YBOCS score greater than 16
Fear based obsessions
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently participating in a cognitive and behavioural therapy (CBT) intervention for obsessive compulsive disorder (OCD)
Current Drug and/or Alcohol abuse or dependence
History of or current Psychosis/mania
Current Suicidal plans or severe depression
Commenced or changed dose of medication over past 3 months
Primary hoarding concerns
Suitable trial of CBT for OCD in the past (Exposure and Response Prevention (ERP) performed in a graded fashion of at least once a week with in-session exposure)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited via the eCentreClinic website (www.ecentreclinic.org). The undergo preliminary screening online. If participants meet all preliminary screening they will undergo a telephone assessment where structured clinical assessment will be administered. Once a formal diagnosis of OCD is assigned then participants will be randomised to one of two groups according to a randomly generated list obtained from www.random.org
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation list will be completed by a third party, using the website www.random.org
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/02/2011
Actual
1/07/2011
Date of last participant enrolment
Anticipated
1/02/2012
Actual
1/02/2012
Date of last data collection
Anticipated
Actual
30/07/2012
Sample size
Target
90
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 258397 0
University
Name [1] 258397 0
Macquarie University
Country [1] 258397 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] 257540 0
None
Name [1] 257540 0
St Vincents Hospital
Address [1] 257540 0
390 Victoria Street
Darlinghurst NSW 2010
Country [1] 257540 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260370 0
University of New South Wales Human Rights and Ethics Committee
Ethics committee address [1] 260370 0
Ethics committee country [1] 260370 0
Australia
Date submitted for ethics approval [1] 260370 0
Approval date [1] 260370 0
16/12/2010
Ethics approval number [1] 260370 0
10392

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

Contacts
Principal investigator
Name 32139 0
Prof Nick Titov
Address 32139 0
ecentreclinic, Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109
Country 32139 0
Australia
Phone 32139 0
+61 2 9850 9901
Fax 32139 0
Email 32139 0
[email protected]
Contact person for public queries
Name 15386 0
Bethany Wootton
Address 15386 0
ecentreclinic, Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109
Country 15386 0
Australia
Phone 15386 0
+21 2 9580 9971
Fax 15386 0
Email 15386 0
[email protected]
Contact person for scientific queries
Name 6314 0
Prof Nickolai Titov
Address 6314 0
ecentreclinic, Centre for Emotional Health, Department of Psychology, Macquarie University, NSW, 2109
Country 6314 0
Australia
Phone 6314 0
+61 2 9850 9901
Fax 6314 0
Email 6314 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.