Clinical trial NCT06539780: Imagery Rescripting as a Treatment for Early Psychosis
Official title: Imagery Rescripting for Early Psychosis: a Multiple-Baseline Single-Case Experimental Design.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Psychotic Disorders
Schizophrenia
Psychoses, Traumatic
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 8
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Schema or core beliefs
timeFrame: 7-9 weeks
measure: Wellbeing
timeFrame: 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)
measure: Self Esteem
timeFrame: 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:
measure: Psychotic symptoms
timeFrame: 2 times: at start and after ending treatment
measure: Trauma Symptoms
timeFrame: 2 times: at start and after ending treatment
measure: Strength of affect
timeFrame: 7-9 weeks
measure: Obtrusiveness of image
timeFrame: 7-9 weeks
measure: Emotions
timeFrame: 7-9 weeks
Other outcomes:
measure: Qualitative Interview
timeFrame: Post treatment up to 3 months
Locations:
city: Amsterdam-Zuidoost
country: Netherlands
facility: Amsterdam UMC
state: Noord Holland
Study officials:
affiliation: Amsterdam UMC
name: Damiaan Denys, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC
name: Arnoud Arntz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: