Imagery Rescripting as a Stand-alone Treatment for OCD and BDD.

NCT06346301 | Recruiting

• 1 other identifier: NL83374.018.23
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this multiple baseline case series study is to test the effect of imagery rescripting (ImRs) in Obsessive Compulsive Disorder (OCD) and Body Dysmorphic Disorder (BDD). Primary objective :The course of schema or core beliefs and change in OCD and BDD. To investigate the effectiveness of imagery rescripting on factors presumed to underlie the disorder, according to schema theory, and on OCD and BDD symptoms. Secondary objective: The change in OCD and BDD symptoms (full questionnaire), schemata and modes, core emotions, mood, affect and obtrusiveness of intrusion. Other objectives are research into the working mechanisms of imagery rescripting by collecting qualitative data from patients and their practitioner in a qualitative interview. For this study, a multiple-baseline single-case experimental design (SCED) is used testing different outcome variables in 18 OCD patients and 18 BDD patients. After a variable baseline period of 3-8 weeks participants will start twice weekly with imagery rescripting for 12 sessions, followed by a 6 week follow up. Participants will rate schema- or core beliefs and OCD or BDD severity on a visual analogue scale. In addition participants will rate core emotions, affect and obtrusiveness of the intrusion. Secondary we will asses four times questionnaires about OCD of BDD symptoms, depression and schemas en modes. After treatment participants will be interviewed about their experiences.

Conditions

Obsessive-Compulsive Disorder; Body Dysmorphic Disorders; Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• Schema of core beliefs

  Idiosyncratic schema- or core beliefs related to Obsessive Compulsive Disorder (OCD) or Body Dysmorphic Disorder (BDD) are daily rated on a Visual Analogue Scales (VAS). The mean of the scores is calculated, range 0-100. A higher score indicates symptom severity.

  15-22 weeks

• Obsessive Compulsive (OCD) and Body Dysmorphic (BDD)symptoms

  OCD and BDD severity is assessed with items based on the Yale Brown Obsessive Compulsive Scale (Y-BOCS(-BDD)) rated on a Visual Analogue Scale. The mean of the scores is calculated, range 0-100. A higher score indicates symptom severity.

  15-22 weeks

Secondary Outcomes (4)

• Core Emotions, affect strength, obtrusiveness of intrusion.

  4 times: at start, end baseline (up to 8 weeks), after treatment (expected 6-7 weeks after start intervention), at follow up (6 weeks after ending treatment)

• Yale Brown Obsessive Compulsive Scale (Y-BOCS(-BDD))

  4 times: at start, end baseline (up to 8 weeks), after treatment (expected 6-7 weeks after start intervention), at follow up (6 weeks after ending treatment)

• Hamilton Depression Rating Scale (HDRS)

  4 times: at start, end baseline (up to 8 weeks), after treatment (expected 6-7 weeks after start intervention), at follow up (6 weeks after ending treatment)

• Young Schema Questionnaire (YSQ) and Schema Mode Inventory (SMI)

  At start, after treatment (expected 6-7 weeks after start intervention), at follow up (6 weeks after ending treatment)

Other Outcomes (1)

• Qualitative interview

  Post treatment up to 8 months

Study Arms (1)

Imagery Rescripting

EXPERIMENTAL

Baseline consists of a random assigned period of 3-8 weeks with measurements and no intervention. Intervention consists of a maximum of 12 sessions of imagery rescripting, provided twice-weekly. Post treatment follow up consists of 6 weeks with only measurements and no intervention.

Behavioral: Imagery rescripting

Interventions

Imagery rescripting BEHAVIORAL

In Imagery Rescripting participants imagine a different sequence of events based on missed emotional needs and rescript until needs are fulfilled. Duration of sessions is up to 90 minutes.

Imagery Rescripting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the criteria for OCD or BDD, a primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
• Are aged 18 and beyond
• Dutch literacy
• Cut-off Y-BOCS of 20
• No change in medication. Stable dose at least 6 weeks prior to study.

You may not qualify if:

• Current (hypo)mania
• Active suicidal plans
• Current psychosis (excluding delusional symptoms related to disorder)
• Alcohol or drugs abuse as diagnosed by Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
• Electroconvulsive therapy in last 6 months
• Neurological disorder or Intelligence Quotient \< 80

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Department of Psychiatry, AMC

Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Body Dysmorphic Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Somatoform Disorders

Study Officials

• Damiaan Denys, Prof.

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

• Arnoud Arntz, Prof.

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tibor van Verseveld

CONTACT

+31619624228; t.r.vanverseveld@amsterdamumc.nl

Judy Luigjes

CONTACT

j.luigjes@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multiple baseline case series design: Patients wil be randomized to different lengths of baseline period and the effectiveness of the treatment is tested by comparing means and slopes of daily reported schema- or core beliefs and OCD and BDD severity,

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: April 4, 2024
• Study Start: April 21, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)