Clinical trial NCT04288609: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Affective Disorder
Keywords: affective disorder
Lead sponsor: Geha Mental Health Center
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2020-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 neuro-developmental conditions in addition to mental health diagnosis;
* Physical disability in addition to mental health conditions;
* Psychotic state;
* active substance abuse;
* custodian

Primary outcomes:
measure: The Observed Tasks of Daily Living - Revised
timeFrame: 3 weeks
measure: Adults Subjective Assessment of Participation
timeFrame: 3 weeks
Secondary outcomes:
measure: The Neurobehavioral Cognitive Status Examination
timeFrame: 3 weeks
measure: Trail Making Test A & B
timeFrame: 3 weeks
measure: Category Fluency Test
timeFrame: 3 weeks
measure: Hamilton Depression Rating Scale Questionnaire
timeFrame: 3 weeks
Other outcomes:
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