Experience sampling tijdens dosisreductie van antipsychotica

Experience sampling for detection of early clinical changes during dose reduction of antipsychotics in patients with a psychotic disorder

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23844

Enrollment

Registered

2018-12-19

Start date

2019-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychosis

Interventions

Thirty patients will use an e-health application (self-monitoring app ‘PsyMate’) based on the experience sampling method (ESM) to evaluate consequences of reduction of antipsychotic medication on chan

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints are ESM measures of: 1. Psychotic experiences 2. Subjective wellbeing (positive affect, negative affect, physical well-being) 3. Social functioning 4. Cognition 5. Sleep 6. Dopamine super-sensitivity (indicator of risk for psychotic relapse) 7. Negative symptoms	—

Secondary

Measure	Time frame
1. Symptom severity as assessed with the Positive and Negative Symptom Scale (PANSS; (Kay et al., 1987)) 2. Mental health and functioning as assessed with the OQ-45 (Lambert et al., 2004) or HoNOS 3. Recovery as assessed with the Recovery Assessment Schedule – Domains and Stages (RAS-DS; (Hancock et al., 2016)) 4. Physical complaints/side effects as assessed with the Somatic miniscreen (SmS; (de Ruiter, 2015)) and SHRS 5. Quality of life as assessed with the MANSA (van Nieuwenhuizen et al., 2000) or KIDSCREEN-27 (The KIDSCREEN Group Europe, 2004).	—

Measure

Time frame

1. Symptom severity as assessed with the Positive and Negative Symptom Scale (PANSS; (Kay et al., 1987)) 2. Mental health and functioning as assessed with the OQ-45 (Lambert et al., 2004) or HoNOS 3. Recovery as assessed with the Recovery Assessment Schedule – Domains and Stages (RAS-DS; (Hancock et al., 2016)) 4. Physical complaints/side effects as assessed with the Somatic miniscreen (SmS; (de Ruiter, 2015)) and SHRS 5. Quality of life as assessed with the MANSA (van Nieuwenhuizen et al., 2000) or KIDSCREEN-27 (The KIDSCREEN Group Europe, 2004).

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Contacts

Public ContactMachteld Marcelis

GGzE

machteld.marcelis@ggze.nl040-2970302

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)