An interventional study of Intendu and Paper and Pencil cognitive remediation training in Affective Disorder, sponsored by Geha Mental Health Center. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-02-28.
Sponsored by Geha Mental Health Center · Not applicable, Interventional, and Treatment
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.
584 studies on the registry are indexed under Mood Disorders; 117 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 429 interventional studies indexed under Mood Disorders.
Browse Mood Disorders studies →Geha Mental Health Center is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Motion Based Cognitive Video Games Software
Other: Intendu
paper and pencil tasks
Other: Paper and Pencil cognitive remediation training
Cognitive remediation using VR adaptive platform for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
Also known as: Motion Based Cognitive Video Games Software
Cognitive remediation using paper and pencil tasks for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
Also known as: Low-Tech remedial training
The Observed Tasks of Daily Living - Revised
Assessment of Functional capacity, score range 1 (dependent in the performance of daily life activities) up to 26 (fully independent in the performance of the daily life activities)
Time frame: 3 weeks
Adults Subjective Assessment of Participation
Questionnaire for assessment of participation in daily life activities: number of participated activities (from 1 to 52, the higher number indicates higher number of participated activities) and frequency of the participation (range from 1 indicates low frequency of participation up to 7 - higher frequency of the participation)
Time frame: 3 weeks
The Neurobehavioral Cognitive Status Examination
Examination cognitive components of attention language, spatial skills, memory, calculations and reasoning. The score range for different sub-tests from 1 up to 4, 6, 8 or 12, with higher score indicates better cognitive functioning
Time frame: 3 weeks
Trail Making Test A & B
Measure of cognitive flexibility and psycho-motor processing speed, the score is a time needed for the test completion, less time that needed indicates better cognitive functioning
Time frame: 3 weeks
Category Fluency Test
Assessment of language fluency, the score is a number of produced words, the higher the number, the better cognitive fluency
Time frame: 3 weeks
Hamilton Depression Rating Scale Questionnaire
Assessment of the depressive symptoms, the higher score indicates more severe depressive symptoms.
Time frame: 3 weeks
No study locations are listed for this record.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Geha Mental Health Center