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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12611000116921
• Date of registration: 01/02/2011
• Prospective Registration: Yes
• Primary sponsor: Macquarie University
• 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
• Date of first enrolment: 01/07/2011
• Target sample size: 90
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12611000116921.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;

Countries of recruitment

Australia

Contacts

• Name: Prof Prof Nickolai Titov

• Name: Dr Bethany Wootton

Key inclusion & exclusion criteria

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
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)

Age minimum: 18 Years
Age maximum: 79 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Anxiety

Obsessive compulsive disorder;
Obsessive compulsive disorder

Intervention(s)

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

Primary Outcome(s)

Obsessive Beliefs Questionnaire (OBQ)[Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up]

Obsessive Compulsive Inventory (OCI)[Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up]

Yale Brown Obsessive Compulsive Disorder Scale (YBOCS)[Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up]

Secondary Outcome(s)

Kessler - 10 (K-10)[Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up]

Treatment Expectancy Questionnaire[Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up]

Generalised Anxiety Disorder - 7 Item (GAD- 7)[Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up]

OCD Diagnosis via Structured Interview - Mini International Neuropsychiatric Interview (MINI)[Baseline
Post-education (8 weeks)
3 month follow up]

Patient Health Questionnaire (PHQ-9)[Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up]

Sheehan Disability Scale (SDS)[Baseline
Mid-education (4 weeks)
Post-education (8 weeks)
3 month follow up]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Macquarie University

Secondary Sponsor(s)

St Vincents Hospital

Ethics review

Status: Approved
Approval date:
Contact:

University of New South Wales Human Rights and Ethics Committee