Comparing Exposure v Imagery Rescripting in People With OCD: a SCED

April 22, 2025 updated by: King's College London

Comparing Exposure v Imagery Rescripting in People With Obsessive Compulsive Disorder (OCD): a Single Case Experimental Design (SCED)

Individuals with OCD may experience intrusive future orientated thoughts and images, which are extremely distressing and interfering in life. This project aims to explore whether imagery rescripting or exposure may be a more effective intervention for individuals with OCD experiencing such images.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ImR
ImR completed as first intervention then ImExp
Other: Imagery intervention
Imagery rescripting or imaginal exposure
Experimental: ImExp
ImExp completed then ImR
Other: Imagery intervention
Imagery rescripting or imaginal exposure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRAS Project ID: 342003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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