Affective Disorder Clinical Trial
Official title:
Effectiveness of a Cognitive Remediation Intervention Based on Virtual Reality for Promotion of Cognitive Functioning and Participation in Daily Life Among Persons With Affective Disorder
The purpose of this study is to test the efficacy of remedial cognitive intervention using The Functional Brain Trainer VR (FBT, Intendo ©) to improve cognitive functioning, participation in daily life occupations, and functional capacity in the field of IADL among people with affective disorders receiving inpatient and daycare mental-health services.
This study is an experimental study, in a pre-post design with a control group, the sampling
is convenience. The study will include 40 people aged 18-60 with a diagnosis of Affective
disorder based on DSM-5.
Inclusion criteria: age 18-60, Diagnosis of Major Depression or Bipolar disorder based on
DSM-5; Mood stabilizing medication for at least 2 weeks, Exclusion criteria: Neurological
disorders and neurodevelopmental conditions in addition to mental health diagnosis; Physical
disability in addition to mental health conditions; Psychotic state; active substance abuse;
custodian.
They will be recruited from active inpatient and daycare wards of the "Geha Mental Health
Center", Israel and will be randomly allocated into two groups: experimental and control. An
experimental group will attend 6 VR based cognitive remediation sessions of 30 minutes for
training response inhibition, self-initiation, cognitive flexibility, sustained attention,
divided attention, working memory, planning, persistence. The control group will complete 6
sessions of 30 minutes of low-tech (paper and pencil tasks) remedial training of the same
cognitive components. These in addition to routine care. The evaluation for symptoms
severity, cognition, functional capacity and participation in daily life activities will be
conducted at the beginning of the study and after about 4 weeks.
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