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NCT Number: NCT06346301

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

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Body Dysmorphic Disorders Mental Disorders Somatoform Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, AMC

Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands

Location status: Recruiting

Location contact

Tibor van Verseveld

CONTACT

[email protected]

+31619624228

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Schema of core beliefs

    Time frame: 15-22 weeks

    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.

  2. Obsessive Compulsive (OCD) and Body Dysmorphic (BDD)symptoms

    Time frame: 15-22 weeks

    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.

Secondary outcomes

  1. Core Emotions, affect strength, obtrusiveness of intrusion.

    Time frame: 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)

    Rated on a Visual Analogue Scale. The mean of the scores is calculated, range 0-100. A higher score indicates symptom severity.

  2. Yale Brown Obsessive Compulsive Scale (Y-BOCS(-BDD))

    Time frame: 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)

    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.

  3. Hamilton Depression Rating Scale (HDRS)

    Time frame: 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)

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

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

    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..

Other outcomes

  1. Qualitative interview

    Time frame: Post treatment up to 8 months

    With an interview, participants will be interviewed after treatment. A qualitative analysis will be used.

Study contacts

Contact information is provided by the study sponsor or research team.

Judy Luigjes

CONTACT

[email protected]

Tibor van Verseveld

CONTACT

[email protected]

+31619624228

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 4, 2024
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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