The aim of the study is to gain insight, based on 30 N=1 trials, into whether intensive ESM monitoring can be used to evaluate the consequences of dose reduction of antipsychotic medication by detecting meaningful within-subject changes in daily…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Momentary mental states and behaviour in terms of psychotic experiences,
subjective well-being (positive affect, negative affect, physical well-being),
social interactions, sleep, cognition, dopamine super-sensitivity and negative
symptoms in the context of daily life.
Secondary outcome
Clinical symptoms, mental health and functioning, recovery, physical
complaints/side effects, quality of life
Background summary
In 2013, there were 290.000 users of antipsychotic medication in the
Netherlands. The multidisciplinary guideline Schizophrenia recommends to aim at
treatment with the lowest effective dose of antipsychotic medication. Often,
the prescribed dose is higher than necessary, with negative consequences for
health, motivation and functioning. While there is a knowledge gap in the
domain of antipsychotics use and its consequences, research with the ultimate
goal of improving quality of life for people with psychotic illness by
responsible medication use and (dis)continuation is necessary. Many
antipsychotic medication trials have been conducted, but this has not resulted
in guidelines for the optimal dose for the individual so far. There is evidence
that dose optimization of antipsychotic medication has a positive effect on
subjective wellbeing. Personalized dose-optimization is predicated on the
assumption that the average appropriate dose is not necessarily the optimal
dose for the individual. Therefore, N=1 trials to self-manage functional
outcome by titrating dose changes are necessary. The experience sampling method
(ESM) offers opportunities for intensive monitoring of symptoms during
discontinuation of antipsychotics because intensive sampling of daily life
experiences allows for the detection of early changes in affective and mental
states. This may contribute to responsible medication use and dose
reduction/(dis)continuation.
Study objective
The aim of the study is to gain insight, based on 30 N=1 trials, into whether
intensive ESM monitoring can be used to evaluate the consequences of dose
reduction of antipsychotic medication by detecting meaningful within-subject
changes in daily life mental states that occur during and after dose reduction.
The present study also aims to determine the clinical effects of dose reduction
of antipsychotic medication under longitudinal ESM self-monitoring by
meta-analyzing these 30 N=1 trials to investigate group-level trends in the
effects of dose reduction.
Study design
Single-case trials.
Study burden and risks
Participation entails that patients will receive extra questionnaires at
baseline, after dose reduction, and at four follow-up moments over a total time
period of approximately four years to evaluate the effects of antipsychotic
dose reduction under intensive monitoring with the PsyMate app. Participants
will also be asked to engage in additional monitoring with the PsyMate app at
the three yearly follow-ups to evaluate the long term effects of dose reduction
on daily mental states and behaviour.
Doctor Poletlaan 39
Eindhoven 5626 ND
NL
Doctor Poletlaan 39
Eindhoven 5626 ND
NL
Listed location countries
Age
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 are kept as few as possible. Only when the safety of the
participant is at risk, exclusion will follow.
Patients will be excluded from the trial if patients are not in remission (at
least 3 months for first episode patients and at least 6 months for multiple
episodes) .
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66325.068.18 |