Experience sampling tijdens dosisreductie van antipsychotica

Rationale: 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.
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 aggregated-level trends in the effects of dose reduction.
Study design: Single-case trials.
Study population: Participants with a psychotic disorder (n=30), aged 16-65 years, who are in stable remission (first episode patients: minimally three months in remission, multiple episode patients: minimally six months in remission) and who have a clinical indication to reduce the dose of or discontinue their antipsychotic medication.
Intervention: 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 changes in momentary 1) psychotic experiences, 2) subjective well-being, 3) social functioning, 4) cognition, 5) sleep, 6) dopamine super-sensitivity, and (7) negative symptoms.
During the two-week baseline period, the dose reduction phase (approximately 12 weeks, depending on the dose reduction scheme that the treating physician has described), the two-weeks post-reduction, monthly follow-ups (7 days per month for a period of six months after dose reduction) and yearly follow-ups (in a three-year period), ESM will be completed daily, at eight semi-random moments during the day.
Main study parameters/endpoints: Primary study parameters are 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 study parameters include symptom severity, mental health and functioning, recovery, physical complaints/side effects, and quality of life.

We hypothesize that the subjective well-being of individual patients will show improvement after dose reduction compared with baseline, that is, patients will experience more positive affect, less negative affect and higher physical well-being during the flow of daily life. Social functioning and cognition of individual patients are also expected to improve. That is, patients will engage more in social activities, appraise these activities as more positive, and feel more able to concentrate in daily life. Dose reduction can be a risk for patients with dopamine super-sensitivity. Therefore, dopamine super-sensitivity will be closely monitored as well.

During the two-week baseline period, ESM will be completed daily, at eight semi-random moments during the day. Baseline assessment will also consist of the PANSS and OQ-45 or HoNOS. Additional questionnaires consist of the MANSA or KIDSCREEN-27, RAS-DS, somatic miniscreen, SHRS, CTQ-s, CIDI substance use, collection of demographic information, and a treatment inventory.
During the dose reduction phase (approximately 12 weeks, depending on the dose reduction scheme that the treating physician has described), the participant will engage in ESM self-monitoring, filling in the PsyMate for a minimum of five days a week. The trained clinician views the feedback together with the participant (as described in the next paragraph) in feedback sessions. During the first four weeks, these sessions take place weekly. After these initial four weeks, these sessions will take place once every two weeks.
After the dose reduction phase, the patient will continue with the ESM self-monitoring for two weeks (minimally five days a week), at the end of which the feedback in the web application is again discussed with the patient. During this session, PANSS, OQ-45 or HoNOS, MANSA or KIDSCREEN-27, RAS-DS, treatment inventory, SmS, and SHRS, CTQ-SF, and CIDI substance use will be assessed. Additionally, participants’ opinion about the feedback procedure will be evaluated at the post-reduction assessment as well.
During the monthly follow-ups (7 days per month for a period of six months after dose reduction), ESM will be completed daily, at eight semi-random moments during the day. These monthly follow-ups also include seven consecutive days of ESM monitoring beforehand on which feedback is provided. After these six months, we will again administer the PANSS, OQ-45 or HoNOS, MANSA or KIDSCREEN-27, RAS-DS, treatment inventory, SmS, SHRS, and CIDI substance use.
During the yearly follow-ups (in a three-year period), we will administer the PANSS, OQ-45 or HoNOS, RAS-DS, MANSA or KIDSCREEN-27, SmS, SHRS, CIDI substance use, and the treatment inventory. Before each yearly assessment, we will ask participants to engage in ESM monitoring for 14 consecutive days. The ESM data will be discussed with the participant (similar to the feedback sessions during the dose reduction phase).

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 changes in momentary 1) psychotic experiences, 2) subjective well-being, 3) social functioning, 4) cognition, 5) sleep, 6) dopamine super-sensitivity, and (7) negative symptoms.