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

Not Applicable

• Conditions: Affective Disorder
• Interventions: Other: Paper and Pencil cognitive remediation training; Other: Intendu

• Registration Number: NCT04288609
• Lead Sponsor: Geha Mental Health Center

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.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-26
• Last Update Submitted: 2020-02-26
• Study First Posted: 2020-02-28
• Last Update Posted: 2020-02-28
• Study Start: 2020-03
• Primary Completion: 2020-11-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paper and pencil tasks	Paper and Pencil cognitive remediation training	paper and pencil tasks
Intendu FBT inpatient	Intendu	Motion Based Cognitive Video Games Software

Primary Outcome Measures

Name	Time	Method
Adults Subjective Assessment of Participation	3 weeks	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)
The Observed Tasks of Daily Living - Revised	3 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Category Fluency Test	3 weeks	Assessment of language fluency, the score is a number of produced words, the higher the number, the better cognitive fluency
Hamilton Depression Rating Scale Questionnaire	3 weeks	Assessment of the depressive symptoms, the higher score indicates more severe depressive symptoms.
Trail Making Test A & B	3 weeks	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
The Neurobehavioral Cognitive Status Examination	3 weeks	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