The main objective is to measure activity levels using an accelerometer in healthy participants, patients with schizophrenia scoring low or average on apathy (< 27 on the apathy items of the Apathy Evaluation Scale (clinician rated; AES-C), Morch…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are activity level (Acti-meter) and the degree of
apathy (AES).
Secondary outcome
Secondary study parameters are negative symptoms, general psychopathology,
depression and the ability to experience pleasure (PANSS, SANS, CDSS and TEPS).
Background summary
Apathy concerns a quantitative reduction of voluntary, goal-directed behaviour
that impairs daily functioning. It is a prominent and severely debilitating
aspect of several psychiatric disorders, most notably schizophrenia. However,
measuring apathy is still a challenge (Clarke et al., 2011). There are a number
of reliable and valid clinical instruments, mainly questionnaires, available to
quantify apathy in terms of core aspects of apathy, including a lack of
initiative and reduction of motivation and goal-directed behavior (Clarke et
al., 2011). However, in order to evaluate the presence of apathy, a certain
degree of knowledge of the clinician or the informant into the patients*
functioning, or insight of the patient in daily activities is required. This
hampers the objectivity of a measurement. Moreover, the clinicians* judgment of
the severity of apathy of a certain patient is possibly influenced by the
average level of apathy in their patient cohort, which could lead to
underestimation of apathy in severely ill cohorts. Therefore, more objective
measures of apathy are warranted (Clarke et al., 2011). Since apathy has been
associated with reduced initiative and goal-directed behavior, measuring
physical activity in patients might be informative on the presence or severity
of apathy (Konig et al., 2014).
Study objective
The main objective is to measure activity levels using an accelerometer in
healthy participants, patients with schizophrenia scoring low or average on
apathy (< 27 on the apathy items of the Apathy Evaluation Scale (clinician
rated; AES-C), Morch-Johnsen et al., 2015) and patients with schizophrenia
scoring high on apathy (* 27 on the AES-C) to investigate whether actigraphy
can be used as an objective measure to designate the presence or severity of
apathy in patients with schizophrenia. Activity levels are already being
measured in a schizophrenia group scoring high on apathy as part of the Apathy
study (Randomized controlled trial of neurostimulation treatment for apathy in
schizophrenia, METC2013.137). The two reference groups (healthy group and the
schizophrenia group scoring low or average on apathy) will be added in this
add-on study to answer two questions: 1) is there a difference in activity
levels between healthy individuals and schizophrenia patients, 2) can
actigraphy be used to separate schizophrenia patients that score low/average on
apathy from patients that score high on apathy?
Study design
Activity levels will be measured during two consecutive weekend days, wherein
participants are free from work, by means of an accelerometer that is worn
(continuously) around the wrist. Before wearing the accelerometer, the
schizophrenia reference group will be interviewed to confirm diagnosis and
evaluate the presence and severity of apathy and other apathy and schizophrenia
related symptoms using the MINI, AES, TEPS, SANS and PANSS measures. Apathy and
anhedonia will also be evaluated in the healthy reference group using a
self-rated questionnaire (AES-S and TEPS). Furthermore, the healthy reference
group will fill in the SCL-90 to evaluate symptoms of psychopathology.
Study burden and risks
Actigrahy is well-tolerated, feasible, ambulatory, and non-invasive and will be
of no harm or bother to the participants (Walther et al., 2015). The
schizophrenia reference group will receive ¤15,- as a compensation for the
interviews. The healthy reference group will receive ¤10,- (the amount is less
because less time is spent on clinical evaluation). Furthermore, the interviews
and questionnaires are not expected to be a high burden to the participants.
Ant. Deusinglaan 2
Groningen 9713AW
NL
Ant. Deusinglaan 2
Groningen 9713AW
NL
Listed location countries
Age
Inclusion criteria
Patients:
- At least 18 y.o.a.
- Diagnosis schizophrenia
- Maximum score AES (27)
- Stable medication use (at least 4 weeks prior to inclusion)
- Written informed consent
- Participants should have a normal level of exercise tolerance and no physical
handicaps that limit their radius of action
- Participants should have weekends, wherein they are free from work (i.e. do
not have to work weekend shifts), Healthy subjects:
- At least 18 y.o.a.
- Maximum score AES (27)
- Written informed consent
- Participants should have a normal level of exercise tolerance and no physical
handicaps that limit their radius of action
- Participants should have weekends, wherein they are free from work (i.e. do
not have to work weekend shifts)
Exclusion criteria
Patients:
- An apathy score above 27 on the apathy subscale of the AES-C
- Current disorder of substance abuse (excluding nicotine addiction)
- Insufficient Dutch language abilities, Healthy subjects:
- History of or current psychiatric or neurological illness
- An apathy score above 27 on the apathy subscale of the AES-S
- Insufficient Dutch language abilities
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 | NL59980.042.16 |