Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000687099
Ethics application status
Approved
Date submitted
19/08/2010
Date registered
19/08/2010
Date last updated
2/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An open trial evaluating the efficacy of an internet based education program for obsessive compulsive disorder
Scientific title
An open trial evaluating the efficacy of an internet based education program for obsessive compulsive disorder
Secondary ID [1] 252510 0
Nil
Universal Trial Number (UTN)
Trial acronym
The OCD Program: Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder 257997 0
Condition category
Condition code
Mental Health 258163 258163 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the educational group will complete 8 online lessons in 8 weeks. Lessons include an educational component in the form of a comic telling the story of 2 individuals who had previously undergone treatment for obsessive compulsive disorder. 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. 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] 257044 0
Behaviour
Intervention code [2] 257050 0
Treatment: Other
Comparator / control treatment
There was no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259025 0
Yale Brown Obsessive Compulsive Disorder Scale (YBOCS)
Timepoint [1] 259025 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Primary outcome [2] 259026 0
Obsessive Compulsive Inventory (OCI)
Timepoint [2] 259026 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Primary outcome [3] 259027 0
Obsessive Beliefs Questionnaire (OBQ)
Timepoint [3] 259027 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [1] 265259 0
Sheehan Disability Scale (SDS)
Timepoint [1] 265259 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [2] 265260 0
Kessler - 10 (K-10), a measure of nonspecific psychological distress.
Timepoint [2] 265260 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [3] 265261 0
Patient Health Questionnaire (PHQ-9)
Timepoint [3] 265261 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [4] 265262 0
Generalised Anxiety Disorder - 7 Item (GAD- 7)
Timepoint [4] 265262 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [5] 265263 0
Treatment Expectancy Questionnaire
Timepoint [5] 265263 0
Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up
Secondary outcome [6] 265264 0
Self Report OCD Severity
Timepoint [6] 265264 0
Baseline
Weekly throughout Education
Post Education
3 month follow up
Secondary outcome [7] 265278 0
OCD Diagnosis via Structured Interview - Mini International Neuropsychiatric Interview (MINI)
Timepoint [7] 265278 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
Medicated on a benzodiazepine
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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited via the VirtualClinic website (www.virtualclinic.org.au). 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
1/09/2010
Actual
3/05/2012
Date of last participant enrolment
Anticipated
Actual
6/06/2012
Date of last data collection
Anticipated
Actual
30/11/2012
Sample size
Target
25
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257491 0
University
Name [1] 257491 0
University of New South Wale
Country [1] 257491 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
CRUfAD, School of Psychiatry, University of New South Wales at St Vincent's Hospital
390 Victoria Street, Darlinghurst NSW2010
Country
Australia
Secondary sponsor category [1] 256726 0
Hospital
Name [1] 256726 0
St Vincents Hospital
Address [1] 256726 0
390 Victoria Street
Darlinghurst NSW 2010
Country [1] 256726 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259517 0
University of New South Wales Human Rights and Ethics Committee
Ethics committee address [1] 259517 0
Ethics committee country [1] 259517 0
Australia
Date submitted for ethics approval [1] 259517 0
Approval date [1] 259517 0
16/03/2011
Ethics approval number [1] 259517 0
10153

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

Contacts
Principal investigator
Name 31542 0
Address 31542 0
Country 31542 0
Phone 31542 0
Fax 31542 0
Email 31542 0
Contact person for public queries
Name 14789 0
Bethany Wootton
Address 14789 0
CRUfAD
Level 4, The O'Brien Centre
St Vincent's Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Country 14789 0
Australia
Phone 14789 0
+61 2 8382 1422
Fax 14789 0
Email 14789 0
[email protected]
Contact person for scientific queries
Name 5717 0
Dr. Nickolai Titov
Address 5717 0
CRUfAD
Level 4, The O'Brien Centre
St Vincent's Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Country 5717 0
Australia
Phone 5717 0
+61 2 8382 1406
Fax 5717 0
Email 5717 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.