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

NCT04288609 | Unknown

• 1 other identifier: Geha Mental Health Center
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Affective Disorder

Keywords

affective disorder

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  3 weeks

Secondary Outcomes (4)

• The Neurobehavioral Cognitive Status Examination

  3 weeks

• Trail Making Test A & B

  3 weeks

• Category Fluency Test

  3 weeks

• Hamilton Depression Rating Scale Questionnaire

  3 weeks

Study Arms (2)

Intendu FBT inpatient

EXPERIMENTAL

Motion Based Cognitive Video Games Software

Other: Intendu

paper and pencil tasks

ACTIVE COMPARATOR

paper and pencil tasks

Other: Paper and Pencil cognitive remediation training

Interventions

Intendu OTHER

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

Intendu FBT inpatient

Paper and Pencil cognitive remediation training OTHER

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

paper and pencil tasks

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60,
• Diagnosis of Major Depression or Bipolar disorder based on DSM-5;
• Mood stabilizing medication for at least 2 weeks,

You may not qualify if:

• 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

Sponsors & Collaborators

• Geha Mental Health Center: lead
• Tel Aviv University: collaborator

MeSH Terms

Conditions

Mood Disorders

Interventions

Paper

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Gilad Eger, PhD

CONTACT

+972523520180; giladeg1@clalit.org.il

Dovrat Cohen, BOT

CONTACT

+972526763854; dovratco@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 28, 2020
• Study Start: March 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02