Imagery Rescripting as a Treatment for Early Psychosis

NCT06539780 | Active Not Recruiting

• 1 other identifier: A2023.0217.0001
• Study Type: interventional
• Target: 8
• 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 early psychosis. Primary objective :The course of schema or core beliefs, wellbeing and self-esteem in early psychosis. Secondary objective: The change in psychotic and trauma symptoms (full questionnaire), core emotions, strength of affect and obtrusiveness of image. 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 8 patients with early psychosis. After a variable baseline period of 1-3 weeks participants will start twice weekly with imagery rescripting for 4-6 sessions, followed by a 3 week follow up. Participants will rate schema- or core beliefs on a visual analogue scale. Wellbeing and selfesteem will be measured 4 times with questionnaires. In addition . Secondary we will asses four times questionnaires about psychotic and trauma symptoms and daily measures of core emotions, affect and obtrusiveness of the intrusion. After treatment participants will be interviewed about their experiences.

Conditions

Psychotic Disorders; Schizophrenia; Psychoses, Traumatic; Psychosis

Outcome Measures

Primary Outcomes (3)

• Schema or core beliefs

  Idiosyncratic schema- or core beliefs related to the early psychosis, VAS scales with range 0-100. A higher score indicates symptom severity.

  7-9 weeks

• Wellbeing

  The MHQoL measures wellbeing. The minimum score is 1 and the maximum score is 21. A higher score indicates more wellbeing.

  4 times: at start, end baseline (up to 3 weeks), after treatment (expected 3 weeks after start of intervention), at follow up (3 weeks after ending treatment)

• Self Esteem

  The Rosenberg Self-Esteem Scale (RSAS) measures self esteem. The minimum score is 0 and the maximum score is 30. A higher score indicates more self esteem.

  4 times: at start, end baseline (up to 3 weeks), after treatment (expected 3 weeks after start of intervention), at follow up (3 weeks after ending treatment)

Secondary Outcomes (5)

• Psychotic symptoms

  2 times: at start and after ending treatment

• Trauma Symptoms

  2 times: at start and after ending treatment

• Strength of affect

  7-9 weeks

• Obtrusiveness of image

  7-9 weeks

• Emotions

  7-9 weeks

Other Outcomes (1)

• Qualitative Interview

  Post treatment up to 3 months

Study Arms (1)

Imagery Rescripting

EXPERIMENTAL

Baseline consists of a random assigned period of 1-3 weeks with measurements and no intervention. Intervention consists of a maximum of 6 sessions of imagery rescripting, provided twice-weekly. Post treatment follow up consists of 3 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 60 minutes.

Imagery Rescripting

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Meet the criteria for schizophrenia spectrum disorder, a primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (5th ed; American Psychiatric Association, 2013)
• Preferably Dutch literacy, as exception English literacy is allowed if the practitioner is able to provide treatment
• Preferably stable in medication at start.

You may not qualify if:

• Current mania
• Active suicidal plans
• Current alcohol or drugs abuse as diagnosed by DSM-5, use is permitted if not significantly influencing treatment outcomes.
• Neurological disorder

Sponsors & Collaborators

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

Study Sites (1)

Amsterdam UMC

Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Damiaan Denys, Prof

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

• Arnoud Arntz, Prof.

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

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, wellbeing and self esteem. Also psychotic and trauma symptoms will be measured.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: December 20, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)