- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04288609
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gilad Eger, PhD
- Phone Number: +972523520180
- Email: giladeg1@clalit.org.il
Study Contact Backup
- Name: Dovrat Cohen, BOT
- Phone Number: +972526763854
- Email: dovratco@clalit.org.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intendu FBT inpatient
Motion Based Cognitive Video Games Software
|
Cognitive remediation using VR adaptive platform for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
Other Names:
|
Active Comparator: paper and pencil tasks
|
Cognitive remediation using paper and pencil tasks for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Observed Tasks of Daily Living - Revised
Time Frame: 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)
|
3 weeks
|
Adults Subjective Assessment of Participation
Time Frame: 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)
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Neurobehavioral Cognitive Status Examination
Time Frame: 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
|
3 weeks
|
Trail Making Test A & B
Time Frame: 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
|
3 weeks
|
Category Fluency Test
Time Frame: 3 weeks
|
Assessment of language fluency, the score is a number of produced words, the higher the number, the better cognitive fluency
|
3 weeks
|
Hamilton Depression Rating Scale Questionnaire
Time Frame: 3 weeks
|
Assessment of the depressive symptoms, the higher score indicates more severe depressive symptoms.
|
3 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Geha Mental Health Center
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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