Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000213640
Ethics application status
Approved
Date submitted
16/02/2023
Date registered
28/02/2023
Date last updated
11/08/2024
Date data sharing statement initially provided
28/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the efficacy of remote stepped care treatment for obsessive-compulsive disorder: A feasibility study.
Scientific title
Exploring the efficacy of remote stepped care treatment for obsessive-compulsive disorder in adults: A feasibility study.
Secondary ID [1] 309008 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obsessive compulsive disorder 329050 0
Condition category
Condition code
Mental Health 326031 326031 0 0
Anxiety
Mental Health 326032 326032 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In Step 1 of this stepped care treatment all participants will read a self-help book 'Stop Obsessing: How to Overcome Your Obsessions and Compulsions' by Edna Foa and Reid Wilson, which will be sent to them in the mail over an 8 week period, along with a suggested reading schedule. During these 8 weeks participants also receive weekly email support from a provisional psychologist or psychologist to answer any questions as they work through the book. Adherence to the readings will be monitored in the weekly emails to participants. We estimate that participants will spend approximately 1 hour per week reading the book and working on the skills.

After completing Step 1, participants symptoms of obsessive-compulsive disorder (OCD) will be re-assessed. Participants whose symptoms of OCD do not improve according to the response criteria (Yale Brown Obsessive Compulsive Scale (YBOCS) reduction of greater than or equal to 25% and a Clinical Global Impression Improvement Scale (CGI-I) score of less than or equal to 3) will go onto receive Step 2 of the remote stepped care treatment.

Step 2 of the stepped-care treatment consists of individually delivered internet-videoconferencing delivered CBT [(VCBT); 8 weekly 50-minute sessions)]. The VCBT will be manualised and will focus on the construction of an exposure hierarchy and graded exposure exercises to items on the exposure hierarchy, combined with refraining of engaging in compulsive behaviours (participants will be asked to cease their compulsions). Exposure hierarchy items will be individualised for each participant and may include items related to contamination/washing, responsibility/checking, unacceptable thoughts/mental rituals or symmetry obsessions/compulsions. The VCBT treatment will be provided by a provisional psychologist or psychologist with experience ranging from 1-5 years. Adherence to the treatment will be monitored by the clinician each week.
Intervention code [1] 325450 0
Behaviour
Intervention code [2] 325451 0
Treatment: Other
Comparator / control treatment
This is an open trial. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333891 0
OCD symptom severity assessed using the Yale Brown Obsessive Compulsive Scale
Timepoint [1] 333891 0
Pre-treatment Weekly in step 1 Mid-treatment (week 5 of step 1) Post step 1 (week 9 post-commencement of intervention) Weekly in step 2 Post step 2 (week 17 post-commencement of intervention; primary endpoint)
Primary outcome [2] 333892 0
OCD symptom severity assessed using the Dimensional Obsessive Compulsive Scale
Timepoint [2] 333892 0
Pre-treatment Mid-treatment (week 5 of step 1) Post step 1 (week 9 post-commencement of intervention) Post step 2 (week 17 post-commencement of intervention; primary endpoint)
Primary outcome [3] 333951 0
Acceptability will be measured with the Client Satisfaction Questionnaire
Timepoint [3] 333951 0
Post step 1 (week 9 post-commencement of intervention) Post step 2 (week 17 post-commencement of intervention; primary endpoint)
Secondary outcome [1] 418633 0
Depressive symptom severity assessed using the Patient Health Questionnaire - 9 item
Timepoint [1] 418633 0
Pre-treatment Weekly in step 1 Mid-treatment (week 5 of step 1) Post step 1 (week 9 post-commencement of intervention) Weekly in step 2 Post step 2 (week 17 post-commencement of intervention)
Secondary outcome [2] 418634 0
OCD symptom severity assessed using the Clinical Global Impression Scale - Severity
Timepoint [2] 418634 0
Pre-treatment Mid-treatment (week 5 of step 1) Post step 1 (week 9 post-commencement of intervention) Post step 2 (week 17 post-commencement of intervention)
Secondary outcome [3] 418635 0
OCD symptom improvement assessed using the Clinical Global Impression Scale - Improvement Scale
Timepoint [3] 418635 0
Mid-treatment (week 5 of step 1) Post step 1 (week 9 post-commencement of intervention) Post step 2 (week 17 post-commencement of intervention)
Secondary outcome [4] 418636 0
Obsessive Beliefs Questionnaire
Timepoint [4] 418636 0
Pre-treatment Mid-treatment (week 5 of step 1) Post step 1 (week 9 post-commencement of intervention) Post step 2 (week 17 post-commencement of intervention)
Secondary outcome [5] 418637 0
Core Beliefs Questionnaire
Timepoint [5] 418637 0
Pre-treatment Mid-treatment (week 5 of step 1) Post step 1 (week 9 post-commencement of intervention) Post step 2 (week 17 post-commencement of intervention)
Secondary outcome [6] 418821 0
Feasibility will be assessed by monitoring participant dropout rates through file audit. This is an additional primary outcome
Timepoint [6] 418821 0
Post step 1 (week 9 post-commencement of intervention) Post step 2 (week 17 post-commencement of intervention; primary endpoint)

Eligibility
Key inclusion criteria
(a) English speaking;
(b) Australian resident;
(c) 18 years-of-age or above;
(d) Have regular access to the internet;
(e) No suicidal plans or intention, or recent history of suicide attempts or deliberate self-harm;
(f) A score of at least 16 on the Yale-Brown Obsessive Compulsive Scale (YBOCS);
(g) A score of at least 7 on the Dimensional Obsessive Compulsive Scale (DOCS);
(h) Meet criteria for OCD as primary on the Diagnostic Interview for Anxiety, Mood, Obsessive-Compulsive and other Neuropsychiatric Disorders (DIAMOND).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
31/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313221 0
University
Name [1] 313221 0
University of Technology Sydney
Country [1] 313221 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Discipline of Clinical Psychology. Graduate School of Health. PO Box 123. Broadway. NSW 2007.
Country
Australia
Secondary sponsor category [1] 314942 0
None
Name [1] 314942 0
Address [1] 314942 0
Country [1] 314942 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312451 0
University of Technology Sydney Human Research Ethics Committee
Ethics committee address [1] 312451 0
Ethics committee country [1] 312451 0
Australia
Date submitted for ethics approval [1] 312451 0
Approval date [1] 312451 0
15/02/2023
Ethics approval number [1] 312451 0

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

Contacts
Principal investigator
Name 124714 0
A/Prof Bethany Wootton
Address 124714 0
Discipline of Clinical Psychology. Graduate School of Health.University of Technology Sydney PO Box 123. Broadway. NSW 2007
Country 124714 0
Australia
Phone 124714 0
+61 2 9514 3942
Fax 124714 0
Email 124714 0
[email protected]
Contact person for public queries
Name 124715 0
Bethany Wootton
Address 124715 0
Discipline of Clinical Psychology. Graduate School of Health.University of Technology Sydney PO Box 123. Broadway. NSW 2007
Country 124715 0
Australia
Phone 124715 0
+61 2 9514 3942
Fax 124715 0
Email 124715 0
[email protected]
Contact person for scientific queries
Name 124716 0
Bethany Wootton
Address 124716 0
Discipline of Clinical Psychology. Graduate School of Health.University of Technology Sydney PO Box 123. Broadway. NSW 2007
Country 124716 0
Australia
Phone 124716 0
+61 2 9514 3942
Fax 124716 0
Email 124716 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Any academic who has expertise in the field of obsessive compulsive disorder

Conditions for requesting access:
• -

What individual participant data might be shared?
• Non-identifiable individual participant data of published results for primary outcome measures.

What types of analyses could be done with individual participant data?
• Any

When can requests for individual participant data be made (start and end dates)?
From:
At the completion of the study and after all relevant manuscripts are published for a period of 5 years.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• From the Chief Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Study protocol Study-related document.doc
Informed consent form    Participant Information Sheet and Consent Form Study-related document.doc
Ethical approval    Ethical approval letter Study-related document.pdf


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.