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Active Not RecruitingNCT06539780

Imagery Rescripting as a Treatment for Early Psychosis

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
8 (estimated)
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
Sex
All
Age
16 Years – 45 Years
Healthy volunteers
Not accepted

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALImagery RescriptingIn 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.

Timeline

Start date
2024-12-20
Primary completion
2025-12-01
Completion
2026-02-01
First posted
2024-08-06
Last updated
2025-12-04

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT06539780. Inclusion in this directory is not an endorsement.

Imagery Rescripting as a Treatment for Early Psychosis (NCT06539780) · Clinical Trials Directory