- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06944366
Comparing Exposure v Imagery Rescripting in People With OCD: a SCED
Comparing Exposure v Imagery Rescripting in People With Obsessive Compulsive Disorder (OCD): a Single Case Experimental Design (SCED)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Talana Adams
- Phone Number: +44 20 7848 0002
- Email: talana.e.adams@kcl.ac.uk
Study Locations
-
-
-
London, United Kingdom
- Recruiting
- Centre for Anxiety Disorders and Trauma
-
Contact:
- Talana Adams
- Phone Number: +44 20 7848 0002
- Email: talana.e.adams@kcl.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or over
- Main diagnosis of OCD (assessed by the Structured Clinical Interview for ICD11)
- Must report future orientated images that are distressing and ego-dystonic
Exclusion Criteria:
- Psychosis, bipolar disorder, or trauma disorder
- Current stimulant or hallucinogenic misuse, alcohol or substance misuse or dependence
- Intellectual disability, dementia, serious cognitive impairment, or organic brain disorder
- Personality Disorder as the main problem
- Active suicidality
- Concurrent engagement in other psychotherapy
- A patient may be taking anti-depressant medication so long as the dose has been stable for 6 weeks and there is no plan to increase the dose.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ImR
ImR completed as first intervention then ImExp
|
Imagery rescripting or imaginal exposure
|
|
Experimental: ImExp
ImExp completed then ImR
|
Imagery rescripting or imaginal exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Obsessive Compulsive Inventory (OCI).
Time Frame: From the start of treatment until the end of treatment at 12 weeks.
|
A 42-item self-report scale to assess the severity and type of OCD symptoms; the OCI uses a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely) and measures distress relating to 7 different subscales (washing, checking, doubting, ordering, obsessions, hoarding, and mental neutralizing).
The total summed score of all items ranged between zero and 168.
This measure will be completed at the beginning and end of each phase.
Higher scores suggest more severe OCD symptomology.
|
From the start of treatment until the end of treatment at 12 weeks.
|
|
Yale-Brown Obsessive-Compulsive scale (Y-BOCS).
Time Frame: From the start of treatment until the end of treatment at 12 weeks.
|
A 10-item self-rated scale used to measure the severity of obsessive-compulsive symptoms and response to treatment; each item is scored from 0 (no symptoms) to 4 (extreme symptoms), with a total ranging from zero to 40.
It will be completed at the beginning and end of each phase.
Higher scores suggest more severe OCD symptomatology.
|
From the start of treatment until the end of treatment at 12 weeks.
|
|
The Impact of Future Events Scale (IFES).
Time Frame: From the start of treatment until the end of treatment at 12 weeks.
|
A 24-item self-rating scale used to measure the impact of intrusive prospective, personally relevant imagery.
Each item is scored from 0 (no symptoms) to 4 (extreme symptoms), with a total ranging from zero to 96.
Higher scores indicate greater symptomatology.
This will be completed at the beginning and end of each phase.
|
From the start of treatment until the end of treatment at 12 weeks.
|
|
The Florida Obsessive Compulsive Inventory (FOCI).
Time Frame: From the start of treatment until the end of treatment at 12 weeks.
|
Designed to measure the severity and frequency of obsessive-compulsive symptoms in individuals.
The severity scale (Part B) of the FOCI was used in the project.
Part B is a 5-item self-rating scale used to measure the frequency, severity, and impact of obsessive-compulsive symptoms; each item is scored from 0 (no symptoms) to 4 (extreme symptoms), with a total ranging from zero to 20.
Higher scores indicate greater symptomology.
|
From the start of treatment until the end of treatment at 12 weeks.
|
|
Visual Analogue Scales (VAS).
Time Frame: From the start of treatment until the end of treatment at 12 weeks.
|
Five daily self-report scales to be designed by the researchers using fixed scale (0=not at all; 10=extremely) answers to measure the following: Frequency of future orientated imagery Severity of future orientated imagery Vividness of future orientated imagery Degree of distress and aversive emotions associated with such imagery The urge to engage in compulsions/to neutralise the imagery. |
From the start of treatment until the end of treatment at 12 weeks.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS Project ID: 342003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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