Experience sampling tijdens dosisreductie van antipsychotica
- Conditions
- psychosis
- Registration Number
- NL-OMON23844
- Lead Sponsor
- GGzE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
1. The participant has a diagnosis of a psychotic disorder.
2. Psychotic symptoms are in remission for at least three months for first episode psychosis and at least six months for multiple episode psychosis.
3. Age 16-65 years.
4. The participant understands the study and is able to provide written informed consent.
5. The participant is not participating in a medication study.
6. The participant is currently using antipsychotic medication and participant and his/her treating clinician agree to discontinuation/dose reduction. Patients with depot medication can also participate.
7. Sufficient command of the Dutch language.
8. Sufficient vision to read the questions in the PsyMate app and sufficient hearing to hear the PsyMate signals.
Exclusion criteria are kept as few as possible. Only when the safety of the participant is at risk, exclusion will follow. Patients with comorbidity, drug- and alcohol abuse or low IQ will be able to participate, so that the sample will reflect the general population of patients with psychosis and the study’s outcomes will be generalizable.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main study parameters/endpoints are ESM measures of:<br>1. Psychotic experiences<br>2. Subjective wellbeing (positive affect, negative affect, physical well-being)<br>3. Social functioning<br>4. Cognition<br>5. Sleep<br>6. Dopamine super-sensitivity (indicator of risk for psychotic relapse)<br>7. Negative symptoms
- Secondary Outcome Measures
Name Time Method 1. Symptom severity as assessed with the Positive and Negative Symptom Scale (PANSS; (Kay et al., 1987))<br>2. Mental health and functioning as assessed with the OQ-45 (Lambert et al., 2004) or HoNOS<br>3. Recovery as assessed with the Recovery Assessment Schedule – Domains and Stages (RAS-DS; (Hancock et al., 2016))<br>4. Physical complaints/side effects as assessed with the Somatic miniscreen (SmS; (de Ruiter, 2015)) and SHRS<br>5. Quality of life as assessed with the MANSA (van Nieuwenhuizen et al., 2000) or KIDSCREEN-27 (The KIDSCREEN Group Europe, 2004).