NCT06944366

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

April 25, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

April 3, 2025

Last Update Submit

April 22, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Obsessive Compulsive Inventory (OCI).

    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).

    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).

    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).

    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).

    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.

Study Arms (2)

ImR

EXPERIMENTAL

ImR completed as first intervention then ImExp

Other: Imagery intervention

ImExp

EXPERIMENTAL

ImExp completed then ImR

Other: Imagery intervention

Interventions

Imagery rescripting or imaginal exposure

ImExpImR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Anxiety Disorders and Trauma

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 25, 2025

Study Start

August 30, 2024

Primary Completion

April 30, 2025

Study Completion

May 20, 2025

Last Updated

April 25, 2025

Record last verified: 2025-01

Locations