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

Affective Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04288609
• Other study ID #: Geha Mental Health Center
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2020
• Source: Geha Mental Health Center
• Contact: Gilad Eger, PhD
• Phone: +972523520180
• Email: giladeg1[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Affective Disorder
• Disease
• Mood Disorders

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Geha Mental Health Center	Tel Aviv University

Outcome

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