Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000678796
Ethics application status
Not yet submitted
Date submitted
14/06/2013
Date registered
20/06/2013
Date last updated
20/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the addition of imagery work improve outcome in standard psychological treatment for Obsessive-Compulsive Disorder (OCD)?
Scientific title
A study evaluating Imagery Re-scripting and Exposure Response Prevention Therapy (IR-ERP) for Obsessive-Compulsive Disorder (OCD).
Secondary ID [1] 282681 0
Nil
Universal Trial Number (UTN)
U1111-1144-4762
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive-Compulsive Disorder (OCD) 289386 0
Condition category
Condition code
Mental Health 289716 289716 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two interventions used: (1) Exposure Response Prevention (ERP) and (2) Image Re-scripting (IR).
ERP is a standard evidence-based behavioural treatment for OCD. It involves a graded approach to expose clients to feared objects/stimulus. IR is an imagery technique which has been found to help build client confidence and improve treatment adherence. This study seeks to integrate the two intervention to better the treatment outcome for clients with OCD.
There will be a total of 10 sessions. The sessions will be once/week for 90 minutes each, to a total of 10 weeks till completion. There is no follow-up plan.
Intervention code [1] 287339 0
Behaviour
Comparator / control treatment
This study is a single case experimental design. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289807 0
Reduction of OCD symptoms as assessed by Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Timepoint [1] 289807 0
Pre-treatment or Baseline (1st session) and Post-treatment (on the 9th session out of 10)
Primary outcome [2] 289808 0
Willingness to engage in ERP treatment as measured by Therapy Evaluation Form
Timepoint [2] 289808 0
Pre-treatment or baseline (1st session) and post-treatment (9th session out of 10)
Secondary outcome [1] 303278 0
Depression, anxiety and stress level as measured by the Depression Anxiety Stress Scale (DASS)
Timepoint [1] 303278 0
Pre-treatment or Baseline (1st session) and Post-treatment (on the 9th session out of 10)
Secondary outcome [2] 303279 0
Self-efficacy as measured by General Self-Efficacy Scale
Timepoint [2] 303279 0
Pre-treatment or baseline (1st session) and Post treatment (9th session out of 10)

Eligibility
Key inclusion criteria
Inclusion criteria are a primary diagnosis of OCD, age between 18 to 65 years old and no history of suicidal ideation 6 months prior to the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with medication will be requested to provide their medication history and those with recent changes (within 3 months) to their medication will be excluded from the study.

Screening for suicidal risk will be done in accordance to standard clinic procedure, which involves the use of suicide screening section of the MINI done during the duty screening over the telephone. Anybody identified as risk will be referred to appropriate support services and not invited to take part in this study.

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)
The student therapist will coordinate with the Psychology Clinic manager at Curtin University to shortlist clients who have been referred for OCD treatment. The therapist will then contact these clients by telephone to do initial screening and clients who wish to proceed with treatment at the clinic will be offered an initial assessment session.
During the initial assessment, clients will be interviewed and assessed using standardized measures such as the SCID-IV and Y-BOCS to determine the nature of the OCD symptoms. Clients who are found to meet the inclusion criteria will be informed of the study by the therapist conducting the assessment session. An information sheet regarding IR-ERP and consent forms will be provided to them, and treatment will only proceed after all consent forms are explained, signed and collected. Clients will clearly be informed that they have the choice not to take part in the study and this will not affect their participation in treatment.
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
This study is planned to recruit 4 clients. This is an appropriate number as the hypotheses set up are a priori and they are based on existing theory.
To ensure the study findings generalizability, this study will run the single-subject studies in parallel. By randomly selecting 4 participants from the targeted population, and monitor each participant over time, the observed changes across the 4 participants would be statistically sufficient to suggest that the intervention effect is generalizable to other members of the target population.
In terms of analysis, this study plans to compare the changes (baseline vs post-treatment) and evaluate if these changes are of clinical significance. Clinical significance will be computed using the Jacobson-Truax method.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 6972 0
6845 - Perth

Funding & Sponsors
Funding source category [1] 287453 0
University
Name [1] 287453 0
Curtin University
Country [1] 287453 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987 Perth,
Western Australia 6845
Country
Australia
Secondary sponsor category [1] 286197 0
None
Name [1] 286197 0
Address [1] 286197 0
Country [1] 286197 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289429 0
Human Research Ethics Committee (HREC)
Ethics committee address [1] 289429 0
Ethics committee country [1] 289429 0
Australia
Date submitted for ethics approval [1] 289429 0
16/05/2013
Approval date [1] 289429 0
Ethics approval number [1] 289429 0
4466

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

Contacts
Principal investigator
Name 40798 0
A/Prof Clare Rees
Address 40798 0
Curtin University
GPO Box U1987 Perth,
Western Australia 6845
Country 40798 0
Australia
Phone 40798 0
+61 8 9266 3442
Fax 40798 0
Email 40798 0
[email protected]
Contact person for public queries
Name 40799 0
Desmond Ang
Address 40799 0
Curtin University
GPO Box U1987 Perth,
Western Australia 6845

Personal address: 4/2 Canning Parade Como WA 6152
Country 40799 0
Australia
Phone 40799 0
+61 424 168820
Fax 40799 0
Email 40799 0
[email protected]
Contact person for scientific queries
Name 40800 0
Clare Rees
Address 40800 0
Curtin University
GPO Box U1987 Perth,
Western Australia 6845
Country 40800 0
Australia
Phone 40800 0
+61 8 9266 3442
Fax 40800 0
Email 40800 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.