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APATHY AND ACTIGRAPHY


- candidate number27535
- NTR NumberNTR6588
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jul-2017
- Secondary IDs2016/635 METC University Medical Center Groningen (UMCG)
- Public TitleAPATHY AND ACTIGRAPHY
- Scientific TitleACTIGRAPHY AS A NEW OBJECTIVE MEASURE FOR APATHY IN SCHIZOPHRENIA
- ACRONYMNA
- hypothesisThe main objective is to investigate whether actigraphy can be used as an objective measure to designate the presence or severity of apathy in patients with schizophrenia. To this end, we will measure activity levels using an accelerometer (i.e. Acti-meter) in i) healthy participants, ii) patients with schizophrenia scoring low or average on clinical instruments measuring apathy (<27 on the apathy items of the Apathy Evaluation Scale (clinician rated; AES-C, Morch-Johnsen et al., 2015) and iii) patients with schizophrenia scoring high on clinical instruments measuring apathy (≥27 on the AES-C). 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?
- Healt Condition(s) or Problem(s) studiedSchizophrenia, Apathy, Actigraphy
- Inclusion criteriaParticipants in the schizophrenia reference group should be at least 18 years of age. Sex, age, medication use, season of actigraphy measurement and education will be matched to the schizophrenia patients scoring high on apathy recruited in the Apathy study (Randomized controlled trial of neurostimulation treatment for apathy in schizophrenia, METC2013.137). Patients Participants are included if they score below 27 on the Apathy subscale of the AES-C. The Mini International Neuropsychiatry Interview- plus (MINI-plus) will be used to confirm the diagnosis of schizophrenia or schizoaffective disorder. At least four weeks prior to the start of the treatment the pharmacological treatment should be stable. ParticipantsThe patients should remain on their regular medication for the complete duration of the study. Furthermore, participants should have a normal level of exercise tolerance and no physical handicaps that limit their radius of action. Moreover, participants should have weekends, wherein they are free from work (i.e. do not have to work weekend shifts)
Participants in the healthy reference group should be at least 18 years of age. Sex, age, season of actigraphy measurement and education will be matched to the schizophrenia patients scoring high on apathy recruited in the Apathy study (Randomized controlled trial of neurostimulation treatment for apathy in schizophrenia, METC2013.137). Healthy controls are included if they score below 27 on the Apathy subscale of the AES-S. Furthermore, participants should have a normal level of exercise tolerance and no physical handicaps that limit their radius of action. Moreover, participants should have weekends, wherein they are free from work (i.e. do not have to work weekend shifts)
- Exclusion criteriaExclusion criteria for the schizophrenia reference group:
• 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

Exclusion criteria for the healthy reference group:
• History of or current psychiatric or neurological illness, based on the report of the subject whether he/she had contact with psychiatrist/neurologist in the past.
• An apathy score above 27 on the apathy subscale of the AES-S
• Insufficient Dutch language abilities
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 15-jul-2017
- planned closingdate15-jul-2018
- Target number of participants80
- InterventionsNA
- Primary outcomeFirst, descriptives are calculated on (e.g. mean, median, maximum, minimum, standard deviation) and plotted for (e.g. histograms and normality plots) abovementioned motor behavior measures. Second, aA factorial ANCOVA is applied performed to investigate differences in the quantity, variability, and initiation of motor behavior between patients with schizophrenia that score high on apathy, patients with schizophrenia that score low/average on apathy and healthy controls, while controlling for age, BMI, illness duration, medication, and depression. Furthermore, a backward stepwise multiple regression is applied to investigate the predictive value of the quantity, variability, and initation of motor behavior for apathy severity. The motor behavior measures are entered separately into the stepwise multiple regression (backward) models as dependent variables and the apathy symptom measure AES-C is entered as a predictor. In a subsequent step, age, Body Mass Index (BMI), illness duration, medication use and depression are entered into the three separate regression models to evaluate if variations in motor behavior could be explained by these variables (Kos et al., submitted). If necessary, we will correct for multiple testing using the SISA Bonferroni correction.
- Secondary outcomeNA
- TimepointsNA
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES m.n. servaas
- CONTACT for SCIENTIFIC QUERIES m.n. servaas
- Sponsor/Initiator European Research Council (ERC)
- Funding
(Source(s) of Monetary or Material Support)
NWO - grant no. 453.11.004, ERC consolidator grant, project no. 312787
- Publications
- Brief summaryBackground of the study:
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).
Objective of the study:
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 population:
The reference groups will be matched to the schizophrenia patients scoring high on apathy that have already been recruited in the Apathy study (Randomized controlled trial of neurostimulation treatment for apathy in schizophrenia, METC2013.137). In each reference group, 40 participants will be included.
Primary study parameters/outcome of the study:
The main study parameters are activity level (Acti-meter) and the degree of apathy (AES).
Secundary study parameters/outcome of the study (if applicable):
Secondary study parameters are negative symptoms, general psychopathology, depression and the ability to experience pleasure (PANSS, SANS, CDSS and TEPS).
- Main changes (audit trail)
- RECORD11-jul-2017 - 12-aug-2017


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