Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06539780

Imagery Rescripting as a Treatment for Early Psychosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Psychosis Mental Disorders Neurocognitive Disorders Psychoses, Traumatic Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC

Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands

About this study

In a multiple baseline case series study the effectiveness of Imagery Rescripting (ImRs) as a treatment for Early Psychosis will be researched. 5-10 participants with a diagnosis of psychosis will be randomized to a waiting list with variable length between 1-3 weeks. After this participants will enter the ImRs (approximately 4-6 sessions), given twice-weekly. Follow up assessment will take place 3 weeks after ending treatment. Primary outcome is schema of core beliefs, wellbeing and self esteem, operationalized by daily measures with visual analogue scales and questionnaires 4 times like the MHQoL and the RSAS. Secondary outcomes are psychotic symptoms (PSYRATS) and trauma symptoms (PCL-5) (measured 4 times), strength of affect and obtrusiveness of image (measured daily with VAS scales).

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 psychotic and trauma symptoms and less strength of affect and obtrusiveness of image.

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 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.

Exclusion criteria

  • 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

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 60 minutes.

Primary outcomes

  1. Schema or core beliefs

    Time frame: 7-9 weeks

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

  2. Wellbeing

    Time frame: 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)

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

  3. Self Esteem

    Time frame: 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)

    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.

Secondary outcomes

  1. Psychotic symptoms

    Time frame: 2 times: at start and after ending treatment

    The PSYRATS measures psychotic symptoms. The total score ranges from 2 to 41, with higher scores indicating more severe symptoms. The Psychotic Symptom Rating Scale (PSYRATS) is comprised of 17 items on specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe).

  2. Trauma Symptoms

    Time frame: 2 times: at start and after ending treatment

    The PCL-5 measures traumatic symptoms. The PTSD Checklist for DSM-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Respondents are asked to rate how bothered they have been by each of 20 items in the past month on a 5- point Likert scale ranging from 0-4. Items are summed to provide a total severity score (range = 0-80).

  3. Strength of affect

    Time frame: 7-9 weeks

    Strength of affect is measured by a visual analogue scale (VAS scale) on a range of 0-100, measured daily, with higher scores indicating more severe symptoms

  4. Obtrusiveness of image

    Time frame: 7-9 weeks

    Obtrusiveness is measured by a visual analogue scale (VAS scale) on a range of 0-100, measured daily, with higher scores indicating more severe symptoms

  5. Emotions

    Time frame: 7-9 weeks

    Idiosyncratic emotions (e.g. shame of guilt) are measured by a visual analogue scale (VAS scale) on a range of 0-100, measured daily, with higher scores indicating more severe symptoms

Other outcomes

  1. Qualitative Interview

    Time frame: Post treatment up to 3 months

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Imagery Rescripting for Early Psychosis: a Multiple-Baseline Single-Case Experimental Design.

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 6, 2024
Registry last updated
Dec 4, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.