The primary objective of this study is to investigate in a randomized controlled trial (RCT) if AquaSnap can improve cognitive functioning in patients with DSM-IV-TR diagnosis of schizophrenia/schizoaffective disorder, OCD or MDD who have cognitive…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure of this research is cognitive functioning at 12
weeks.
Secondary outcome
The secondary outcome measures include the severity of symptoms, blood marker
abnormalities, electro-encephalogram (EEG), level of functioning and cortisol
level.
Background summary
A majority of patients with a psychiatric disorder such as major depressive
disorder (MDD), schizophrenia or obsessive-compulsive disorder (OCD), suffers
from cognitive dysfunction (e.g. in attention, memory, and planning ability).
Cognitive dysfunction can play a major role in functional capacity and
independence in everyday activities. Improving cognitive functioning in
patients with psychiatric disorders may lead to being alble to keep or earlier
return to employment and independent living and therefore to reduced healthcare
and economic costs.
Availability of interventions to improve cognitive dysfunction is limited. The
companies MyCognition and Preloaded have developed thegame Aquasnap designed to
enhance and sustain performance leading to reduction in cognitive deficits. A
potential advantage of tAquaSnap over and above existing cognitive remediation
test batteries is that more subjects comply with treatment because playing the
game is enjoyable.
Study objective
The primary objective of this study is to investigate in a randomized
controlled trial (RCT) if AquaSnap can improve cognitive functioning in
patients with DSM-IV-TR diagnosis of schizophrenia/schizoaffective disorder,
OCD or MDD who have cognitive deficits. Secondary objectives are to investigate
1) the usability and acceptability of AquaSnap 2) the association of changes
in cognitive functioning with biological, psychosocial and clinical parameters.
Study design
The design is a randomized controlled trial. Subjects will be randomized at
entry to one of two treatment groups: Current management (TAU) or Current
management plus AquaSnap.
Intervention
Subjects will receive either Treatment as Usual (TAU) or TAU plus a link with
which they can play AquaSanp at home, at least three times a week for at least
half an hour for 12 weeks.
Study burden and risks
Subjects will be assessed at baseline, week 4, week 8 and week 12 with the
MyCognition Cognitive Power Score (MYCQ). At baseline and week 12 they will
also be assessed with the CANTAB, clinical self report scales, EEG hair
cortisol and blood markers. Subjects in the treatment condition can play
AquaSnap. Side effects of playing AquaSnap are not expected. Benefit for the
patient may be improved cognitive functions.
Moorgate 25
London EC2R 6AY
GB
Moorgate 25
London EC2R 6AY
GB
Listed location countries
Age
Inclusion criteria
- DSM-IV-TR diagnosis of schizophrenia/schizo-affective disorder, obsessive compulsive disorder or major depressive disorder
- Fluent in Dutch
- Clinically stable
- Male or female 16 to 55 years
Exclusion criteria
- High risk of suicide (score of 2 or more on HAM-D suicide item)
- Unstable medical disorder
- Current substance abuse disorder
- History of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
- Premorbid IQ < 70
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 | NL46634.018.13 |