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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Psychotic symptoms | 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 times: at start and after ending treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Interview | With an interview, participants will be interviewed after treatment. A qualitative analysis will be used. | Post treatment up to 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damiaan Denys, Prof | Amsterdam UMC | Principal Investigator |
| Arnoud Arntz, Prof. | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Amsterdam-Zuidoost | North Holland | 1105 AZ | Netherlands |
No Due to privacy regulations patient data will not be shared unless the European Union (EU) regulations on data protection are guaranteed.
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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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.
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| Trauma Symptoms | 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). | 2 times: at start and after ending treatment |
| Strength of affect | 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 | 7-9 weeks |
| Obtrusiveness of image | 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 | 7-9 weeks |
| Emotions | 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 | 7-9 weeks |