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Imagery Rescripting as a Treatment for Early Psychosis

Not Applicable
Recruiting
Conditions
Psychosis
Psychotic Disorders
Schizophrenia
Psychoses, Traumatic
Interventions
Behavioral: Imagery Rescripting
Registration Number
NCT06539780
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
8
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Imagery RescriptingImagery RescriptingBaseline 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.
Primary Outcome Measures
NameTimeMethod
Wellbeing4 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.

Schema or core beliefs7-9 weeks

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

Self Esteem4 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 Outcome Measures
NameTimeMethod
Psychotic symptoms2 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).

Trauma Symptoms2 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).

Obtrusiveness of image7-9 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

Strength of affect7-9 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

Emotions7-9 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

Trial Locations

Locations (1)

Amsterdam UMC

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Amsterdam-Zuidoost, Noord Holland, Netherlands

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