search
Back to results

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

Primary Purpose

Affective Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intendu
Paper and Pencil cognitive remediation training
Sponsored by
Geha Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Affective Disorder focused on measuring affective disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intendu FBT inpatient

    paper and pencil tasks

    Arm Description

    Motion Based Cognitive Video Games Software

    paper and pencil tasks

    Outcomes

    Primary Outcome Measures

    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)
    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)

    Secondary Outcome Measures

    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
    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
    Category Fluency Test
    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
    Assessment of the depressive symptoms, the higher score indicates more severe depressive symptoms.

    Full Information

    First Posted
    February 10, 2020
    Last Updated
    February 26, 2020
    Sponsor
    Geha Mental Health Center
    Collaborators
    Tel Aviv University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04288609
    Brief 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
    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

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2020 (Anticipated)
    Primary Completion Date
    November 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Geha Mental Health Center
    Collaborators
    Tel Aviv University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Affective Disorder
    Keywords
    affective disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    single
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intendu FBT inpatient
    Arm Type
    Experimental
    Arm Description
    Motion Based Cognitive Video Games Software
    Arm Title
    paper and pencil tasks
    Arm Type
    Active Comparator
    Arm Description
    paper and pencil tasks
    Intervention Type
    Other
    Intervention Name(s)
    Intendu
    Other Intervention Name(s)
    Motion Based Cognitive Video Games Software
    Intervention Description
    Cognitive remediation using VR adaptive platform for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
    Intervention Type
    Other
    Intervention Name(s)
    Paper and Pencil cognitive remediation training
    Other Intervention Name(s)
    Low-Tech remedial training
    Intervention Description
    Cognitive remediation using paper and pencil tasks for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
    Primary Outcome Measure Information:
    Title
    The Observed Tasks of Daily Living - Revised
    Description
    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)
    Time Frame
    3 weeks
    Title
    Adults Subjective Assessment of Participation
    Description
    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)
    Time Frame
    3 weeks
    Secondary Outcome Measure Information:
    Title
    The Neurobehavioral Cognitive Status Examination
    Description
    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
    Time Frame
    3 weeks
    Title
    Trail Making Test A & B
    Description
    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
    Time Frame
    3 weeks
    Title
    Category Fluency Test
    Description
    Assessment of language fluency, the score is a number of produced words, the higher the number, the better cognitive fluency
    Time Frame
    3 weeks
    Title
    Hamilton Depression Rating Scale Questionnaire
    Description
    Assessment of the depressive symptoms, the higher score indicates more severe depressive symptoms.
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gilad Eger, PhD
    Phone
    +972523520180
    Email
    giladeg1@clalit.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dovrat Cohen, BOT
    Phone
    +972526763854
    Email
    dovratco@clalit.org.il

    12. IPD Sharing Statement

    Learn more about this trial

    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

    We'll reach out to this number within 24 hrs