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

Geha Mental Health Center

Status: Unknown

Conditions: Affective Disorder

Treatments: Other: Intendu; Other: Paper and Pencil cognitive remediation training

Study type: Interventional

Funder types: Other

Identifiers

NCT04288609

Geha Mental Health Center

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intendu FBT inpatient

Experimental group

Description:

Motion Based Cognitive Video Games Software

Treatment:

Other: Intendu

paper and pencil tasks

Active Comparator group

Description:

paper and pencil tasks

Treatment:

Other: Paper and Pencil cognitive remediation training