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Trial registered on ANZCTR


Registration number
ACTRN12618000843257p
Ethics application status
Submitted, not yet approved
Date submitted
9/05/2018
Date registered
18/05/2018
Date last updated
18/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of group Cognitive-Behavioural Therapy for Obsessive-Compulsive Disorder
Scientific title
Effectiveness of group Cognitive-Behavioural Therapy in reducing the symptom severity of Obsessive-Compulsive Disorder
Secondary ID [1] 294839 0
None
Universal Trial Number (UTN)
U1111-1213-7856
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder 307785 0
Condition category
Condition code
Mental Health 306828 306828 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is exposure and response (ERP) therapy delivered in a group format. ERP is the gold-standard treatment for obsessive-compulsive disorder. Each session involves the review of homework exercises, provision of psych education regarding the maintenance of OCD, setting up hierarchies and exposure exercises. Group numbers will not exceed 10 per group. All sessions administered by two clinical psychologists trained in ERP. Adherence to the treatment occurs at the beginning of each session when homework tasks are reviewed. Homework exercises include planned exposure exercises, reading and monitoring mood and anxiety levels. The intervention will consist of 1 group session every week of 2 hours duration conducted over 10 consecutive weeks. A final follow-up session will be held one-month post-treatment
Intervention code [1] 301149 0
Treatment: Other
Intervention code [2] 301230 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305824 0
OCD severity measured using the Obsessive Compulsive Inventory - Revised.
Obsessive Compulsive InventoryRevised (Foa et al. 2002) is a self report inventory for measuring symptom severity of OCD. The inventory contains 18 items and six subscales that
measure: washing, checking, ordering, obsessing, hoarding, and neutralizing.
Timepoint [1] 305824 0
Pre-intervention (within 24 hours of first session), mid-intervention (5 weeks post-commencement of intervention), post-intervention (10 weeks post-commencement of intervention), and follow-up (one-month post-completion of 10 week intervention).
Primary outcome [2] 305825 0
Composite Outcome:
Depression, Anxiety and StressDepression Anxiety Stress Scale [DASS21] (P. F. Lovibond & Lovibond, 1995) is a 21 item instrument that measures an individual’s feelings of stress, anxiety and depression over the previous week. Shorter than the original 42 item scale, the DASS21 contains three 7 item subscales (stress; anxiety; and depression) that are each summed to obtain a total subscale score with higher scores indicating more negative symptoms.
Timepoint [2] 305825 0
Pre-intervention (within 24 hours of first session), mid-intervention (5 weeks post-commencement of intervention), post-intervention (10 weeks post-commencement of intervention), and follow-up (one-month post-completion of 10 week intervention).
Secondary outcome [1] 346686 0
Obsessive Beliefs
Measured using the Obsessive Beliefs Questionnaire -20 items.
Timepoint [1] 346686 0
Pre-intervention (within 24 hours of first session), mid-intervention (5 weeks post-commencement of intervention), post-intervention (10 weeks post-commencement of intervention), and follow-up (one-month post-completion of 10 week intervention).
Secondary outcome [2] 346687 0
Well-being: The WHO Five Well-being index
Timepoint [2] 346687 0
Pre-intervention (within 24 hours of first session), mid-intervention (5 weeks post-commencement of intervention), post-intervention (10 weeks post-commencement of intervention), and follow-up (one-month post-completion of 10 week intervention).

Eligibility
Key inclusion criteria
Individuals over the age of 18 who are diagnosed with OCD
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active psychosis, intellectual disability

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will use repeated measures ANCOVA where time (Pre, mid, post, F/up) is the independent variable and symptom outcome is the dependent variable. We will control for pre-treatment OC symptom severity in the analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/07/2018
Actual
Date of last participant enrolment
Anticipated
29/06/2020
Actual
Date of last data collection
Anticipated
2/11/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 299436 0
University
Name [1] 299436 0
Curtin University
Country [1] 299436 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of Psychology
Curtin University
Kent Street
Bentley WA 6848
Country
Australia
Secondary sponsor category [1] 298725 0
None
Name [1] 298725 0
Address [1] 298725 0
Country [1] 298725 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300334 0
Curtin University Ethics committee
Ethics committee address [1] 300334 0
Curtin University
GPO Box U1987
Bentley
6845
Ethics committee country [1] 300334 0
Australia
Date submitted for ethics approval [1] 300334 0
09/05/2018
Approval date [1] 300334 0
Ethics approval number [1] 300334 0

Summary
Brief summary
Exposure and Response Prevention (ERP), delivered individually, is the gold-standard treatment for Obsessive-Compulsive Disorder (OCD). However, there are significant barriers
to accessing this form of treatment such as a limited number of specialists skilled in the
provision of the treatment and long wait-lists. As such,attention has been given to exploring alternative modes of delivery of ERP. These alternatives include provision of ERP via the Internet and provision of ERP in a group format. A recent meta-analysis (Schwartz et al., 2016) found that ERP provided in a group format has equivalent effect sizes to individually administered ERP. The 12 studies in the meta-analysis were controlled trials comparing group ERP to wait-list and to individual ERP. The results of this meta-analysis lend support for the provision of ERP in group formats in clinical practice. However, most studies to date have been conducted in highly controlled settings (e.g. university clinics) and so little is known about how effective group ERP is in typical clinical settings. The aim of this study is to evaluate the effectiveness of group ERP in a ‘real-world’ clinical setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83330 0
Prof Clare Rees
Address 83330 0
School of Psychology
Curtin University
Kent Street
Bentley WA 6845
Country 83330 0
Australia
Phone 83330 0
+61 8 9266 3442
Fax 83330 0
Email 83330 0
[email protected]
Contact person for public queries
Name 83331 0
Clare Rees
Address 83331 0
School of Psychology
Curtin University
Kent Street
Bentley WA 6845
Country 83331 0
Australia
Phone 83331 0
+61 8 9266 3442
Fax 83331 0
Email 83331 0
[email protected]
Contact person for scientific queries
Name 83332 0
Clare Rees
Address 83332 0
School of Psychology
Curtin University
Kent Street
Bentley WA 6845
Country 83332 0
Australia
Phone 83332 0
+61 8 9266 3442
Fax 83332 0
Email 83332 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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