The objective of this pilot study is to collect data in psychotic patients to design a subsequent larger randomised control study. An applied game using biofeedback has been developed by an independent game studio based. This game will be used to…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate whether psychotic patients are able to play the game, reach the
target level and improve over time, the game results will be evaluated
(duration to reach/maintain the target level and improvement over time). User
experience will be evaluated with short questionnaires.
Secondary outcome
User feedback will be used to improve the game or adapt game settings. Results
will also be used to choose which conditions will be used in a subsequent study
and to calculate sample size for a larger randomized control study.
Background summary
There is a need for cost-effective treatment approaches in mental health care.
Applied computer games have been found promising additional training tools for
patients with medical or psychiatric diseases (DeShazo et al., 2010; Oord,
Ponsioen, Geurts, Brink, Prins, 2012). In the present pilot study we aim to
investigate the usability of an applied game as a training tool to decrease
stress and increase attentional focussing in psychotic patients.
Study objective
The objective of this pilot study is to collect data in psychotic patients to
design a subsequent larger randomised control study. An applied game using
biofeedback has been developed by an independent game studio based. This game
will be used to investigate whether psychotic patients are able to play the
game, reach the target level (relaxation, concentration or attentiveness), and
whether playing the game repeatedly, improves their performance. User
experience will be evaluated to investigate usability, as well as positive or
negative effects of playing the game.
Study design
The game comprises three training conditions (relaxation, concentration and
attentiveness) teaching individuals to relax, to regulate heart rate and to
focus attention. Patients will consecutively be assigned to one of the three
conditions.
Intervention
A training period of 10 days will be offered. The game will be played for 10
minutes twice a day. The patient is seated behind a computer, wearing a
lightweight, wireless headset with one dry sensor on the forehead or an earclip
attached to the earlobe. Biofeedback is used to play the game: e.g. the
computer game reacts to the biological state of the player (level of
concentration, attentiveness or relaxation) so that the player reaches a higher
level in the game.
Study burden and risks
There are no known risks associated with playing the game. However, since
psychotic patients are vulnerable, they may experience stress, tiredness or
increase of positive symptoms during or just after playing the game. Therefore,
the study is conducted in the clinic and a research assistant is present to
help the patient in case of questions or distress. Benefits may be positive
feelings during or after playing the game.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Signed informed consent form
- DSM-IV diagnosis schizofrenia, schizofreniform disorder, schizoaffective disorder or psychose NAO.
- Age 18-30 years
Exclusion criteria
- patients who are not capable to understand the study outline and/or provide written informed consent.
- patients who are coercively admitted to the ward will not be invited to participate
- Conditions placing patients at risk according to the judgment of the clinical staff, such as severe anxiety, behavioral problems, medical conditions, etc.
- patients who use more than 6 mg lorazepam a day (or equivalent dosage of other benzodiazepines)
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 | NL44946.041.13 |