The primary aim is to assess the feasibility of using PsyMate by emergency psychiatric patients and their partners. The secondary objective is to obtain observational data to design future ESM studies to be carried out within our department.
ID
Source
Brief title
Condition
- Suicidal and self-injurious behaviours NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters/ endpoints will be:
1)The number and percentage of participants completing the study;
2) the percentage of PsyMate beeps followed (i.e. questionnaires filled out)
per participant;
3) the participants* experiences with the PsyMate.
The secondary endpoints will be the outcomes on the test-battery, and daily ESM
questionnaires.
Secondary outcome
- psychiatric symptoms (as assessed by the brief psychiatric rating scale, BPRS
and the health of the nations outcomes scale, HONOS, mean +/- standard
deviation)
- relationship quality (as assessed by the relationship assessment scale, RAS,
mean +/ standard deviation)
- Quality of sleep (likert scale, mean +/- standard deviation)
- Positive affect (average of cheerful, satisfied, enthusiastic, relaxed)
(likert scale, mean +/- standard deviation)
- Negative affect (average of down, suspicious, guilty, irritated, lonely and
anxious) (likert scale, mean +/- standard deviation)
- View of self (likert scale, mean +/- standard deviation)
- (social) activities (percentage of time per option)
- Stress during activity (likert scale, mean +/- standard deviation)
General patient information will be reported as follows:
- Age (mean +/- standard deviation)
- Sex (number and % female)
- educational level (low * middle * high, number and percentage in each
category);
- work (none / part-time / full-time, number and percentage in each category);
- participants with children (number and percentage)
- of participants with children: number of children (mean and standard
deviation)
- past diagnosis (depression / bipolar disorder / schizophrenia / cluster a/b/c
personality disorder, number and percentage of each category);
- current psychiatric condition (depression / bipolar disorder / schizophrenia
/ anxiety disorder / cluster a/b/c personality disorder, number and percentage
of each category)
- current use of benzodiazepines / antidepressants / antipsychotics / mood
stabilizer (number and percentage of each category);
- current psychotherapy (number and percentage).
Background summary
Patients are typically referred to the Psychiatric Emergency Service Amsterdam
(SPA) because of a sudden start or increase of psychiatric symptoms resulting
in a risk of serious harm to the patient or his/her surroundings. The SPA aims
to provide personalized treatment, and include and support the patients* social
network.
Experience Sampling Method (ESM) strategies nudge patients to fill out
questionnaires multiple times per day, to obtain information on mood,
psychological complaints, activities, and social and environmental context.
PsyMate is a smartphone-based ESM app specifically designed for psychiatric
care and research.
Until now, ESM has not been used at the Psychiatric Emergency Service Amsterdam
(SPA). We expect that use of PsyMate by patients and their partners at the SPA
will be feasible. Also, we hypothesize that the resulting data could be used
for scientific research and personalization of (network-oriented) treatment.
Study objective
The primary aim is to assess the feasibility of using PsyMate by emergency
psychiatric patients and their partners. The secondary objective is to obtain
observational data to design future ESM studies to be carried out within our
department.
Study design
The current study is an observational pilot study.
Intervention (if applicable): All participants (patients and their partners)
will use PsyMate four days per week for four weeks. On these days, they will
fill out a morning questionnaire, an evening questionnaire and a repeating
questionnaire. The morning questionnaire will cover sleep quality, the evening
questionnaire general experiences during the day and with PsyMate. The
repeating questionnaire will be filled out at semi-random moments and will
cover positive and negative affect, psychiatric symptoms, time spent on
(social) activities, stress during (social) activities, social and
environmental context
Moreover, all participants will be subjected to a modest test battery at
baseline and end-of-study (week 5). Questionnaires will evaluate general
psychiatric symptoms, relationship quality between the patient and his/ her
partner. At end-of-study, a questionnaire on the PsyMate user experiences will
be filled out.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Based on previous studies and clinical
experience, the risk of using PsyMate is regarded low. Burden mostly consists
of repeatedly filling out the questionnaires, but previous studies indicate
that the burden is low as well. This study does not offer financial rewards or
other specific incentives.
Eerste Constantijn Huygensstraat 38
Amsterdam 1054 BR
NL
Eerste Constantijn Huygensstraat 38
Amsterdam 1054 BR
NL
Listed location countries
Age
Inclusion criteria
Population
15 patients who are referred to our department because of suicidal thoughts or
behavior and accepted for out-patient treatment and their 15 live-in partners
will be enrolled upon the start of treatment.
criteria for all 30 participants:
- To be mentally competent to decide about participating in the study
- Written informed consent has been provided
- Mastery of Dutch Language in speech and writing;
- In possession of an electronic device, e.g. smart-phone, i-pad, which
supports the PsyMate app;
- Ability to use the PsyMate app and comply with the study protocol (clinical
judgment treating physician).
Exclusion criteria
- Participation in another study that is ongoing at our department;
- Homelessness;
- Primary addiction problem
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 | NL71906.068.20 |