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
NCT ID: NCT04288609
Last Updated: 2020-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-03-31
2020-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intendu FBT inpatient
Motion Based Cognitive Video Games Software
Intendu
Cognitive remediation using VR adaptive platform for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
paper and pencil tasks
paper and pencil tasks
Paper and Pencil cognitive remediation training
Cognitive remediation using paper and pencil tasks for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
Interventions
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Intendu
Cognitive remediation using VR adaptive platform for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
Paper and Pencil cognitive remediation training
Cognitive remediation using paper and pencil tasks for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Major Depression or Bipolar disorder based on DSM-5;
* Mood stabilizing medication for at least 2 weeks,
Exclusion Criteria
* Physical disability in addition to mental health conditions;
* Psychotic state;
* active substance abuse;
* custodian
18 Years
60 Years
ALL
No
Sponsors
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Tel Aviv University
OTHER
Geha Mental Health Center
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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Geha Mental Health Center
Identifier Type: -
Identifier Source: org_study_id