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

Imagery Rescripting for Obsessive Compulsive Disorder and Body Dysmorphic Disorder: a Multiple-Baseline Single-Case Experimental Design.

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.

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder; Anxiety Disorders; Body Dysmorphic Disorders
• Intervention / Treatment: Behavioral: Imagery rescripting

Detailed Description

In a multiple baseline case series study the effectiveness of Imagery Rescripting (ImRs) as a treatment for Body Dysmorphic Disorder (BDD) and Obsessive Compulsive Disorder (OCD) will be researched. 18 participants with OCD and 18 participants with BDD will be randomized to a waiting list with variable length between 3-8 weeks. After this participants will enter a 1-3 session for preparation followed by 12 sessions with ImRs, given twice-weekly. Follow up assessment will take place 6 weeks after ending treatment. Primary outcome is schema of core beliefs and OCD or BDD symptoms, operationalized by daily measures with visual analogue scales. Also 4 times the investigator measures the OCD or BDD symptoms with the Yale Brown Obsessive Compulsive Scale (Y-BOCS), depression with the Hamilton Depression Rating Scale (HDRS) and 3 times the schema and mode questionnaires with the Young Schema Questionnaire (YSQ) and de Schema Mode Inventory (SMI). The hypothesis is that the primary outcomes will reduce more during the intervention phase compared to the baseline phase and remain stable or even further improve in the follow-up phase. For the secondary outcomes the investigator hypothesized a decrease in depressive symptoms, a decrease in the emotions guilt or shame and first an increase in sadness, fear and angriness followed by an decrease. The largest effect is expected from pre- to post treatment, with a relative stable little change during baseline and follow-up.

Results will be analyzed using visual inspection, repeated measures ANOVA and multilevel analysis, pooling the effects of the individual cases. Finally, participants will be interviewed post treatment about their experiences during treatment.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tibor van Verseveld; Phone Number: +31619624228; Email: t.r.vanverseveld@amsterdamumc.nl
• Study Contact Backup: Name: Judy Luigjes; Email: j.luigjes@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam-Zuidoost, Noord-Holland, Netherlands, 1105 AZ
      • Recruiting
      • Department of Psychiatry, AMC
      • Contact: Tibor van Verseveld; Phone Number: +31619624228; Email: t.r.vanverseveld@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imagery Rescripting; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core Emotions, affect strength, obtrusiveness of intrusion.	Rated on a Visual Analogue Scale. The mean of the scores is calculated, range 0-100. A higher score indicates symptom severity.	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))	Y-BOCS(-BDD) assesses severity of OCD or BDD symptoms. The minimum score is 0, the maximum score is 48. A higher score indicates symptom severity.	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)	The Hamilton Depression Rating Scale assesses severity of depression. The minimum score is 0, the maximum score is 52. A higher score indicates symptom severity.	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)	The Young Schema Questionnaire and the Schema Mode Inventory assesses severity of schemas and modi. The minimum score per scale is 0, the maximum score is 6. A higher score indicates symptom severity..	At start, after treatment (expected 6-7 weeks after start intervention), at follow up (6 weeks after ending treatment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interview	With an interview, participants will be interviewed after treatment. A qualitative analysis will be used.	Post treatment up to 8 months

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Damiaan Denys, Prof., Amsterdam UMC; Principal Investigator: Arnoud Arntz, Prof., Amsterdam UMC

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Somatoform Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Anxiety Disorders; Body Dysmorphic Disorders
• Other Study ID Numbers: NL83374.018.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to privacy regulations patient data will not be shared unless the European Union (EU) regulations on data protection are guaranteed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No