Back to resultsCognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
Primary Purpose
Depression, Subclinical Depressive Symptoms
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized cognitive training (CCT) using EndeavorRx
Sponsored by
About this trial
This is an interventional supportive care trial for Depression focused on measuring Cognitive Training Video Game
Eligibility Criteria
Inclusion Criteria: Participant is willing to engage in a technology-based intervention (technology will be provided if not already accessible to participant). Self-reported depressive symptoms Participants will be required to maintain a stable dose of medications for 4 weeks prior to the first assessment Exclusion Criteria: Color blindness Unable to play the video game for any reason The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnosis of clinical depression, psychosis, or Autism Spectrum Disorder Enrolled in current psychotherapy Endorses any item on the Columbia Suicide Severity Rating Scale (C-SSRS) (has present suicidal ideation) Has had any changes to their medication in the 4-weeks prior to study enrollment
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Computerized cognitive training (CCT) using EndeavorRx
Arm Description
Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory.
Outcomes
Primary Outcome Measures
Change in depressive symptoms as measured by Children's Depression Inventory (CDI)
Self-report, 28 item scale on depressive symptoms. Total scores on this measure range from 0 to 54. Higher scores indicate worse depressive symptoms.
Change in cognitive control capacity NIH toolbox cognition composite score
Secondary Outcome Measures
Depressive symptoms as measured by CDI
Self-report, 28 item scale on depressive symptoms. Total scores on this measure range from 0 to 54. Higher scores indicate worse depressive symptoms.
Cognitive control capacity as measured by NIH toolbox (NIHTB) cognition composite score
The NIHTB (NIHTB) cognitive battery consists of 10 tasks and can be administered in 40 min. The scores can be evaluated separately, or they can be combined into composite scores: crystallized cognition composite (reflecting the ability to access information from long-term memory and general knowledge), fluid cognition composite (reflecting the processing ability to adapt to novel environment and solve problems), and overall cognitive function composite (a combination of both crystallized and fluid scores).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05697627
Brief Title
Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
Official Title
Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
The purpose of the study is to determine how cognitive control training (CCT) changes behavior in youth with subclinical depressive symptoms. This research will show what types of behavior changes are important for CCT to help reduce depressive symptoms. In the future, we will use this information to try to improve how we prevent the development of depression, so that it can help more patients.
Detailed Description
The primary study investigator acknowledges contributions from Kate Fitzgerald, Emily Bilek, Christopher Monk, and Adriene Beltz.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Subclinical Depressive Symptoms
Keywords
Cognitive Training Video Game
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Computerized cognitive training (CCT) using EndeavorRx
Arm Type
Experimental
Arm Description
Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory.
Intervention Type
Device
Intervention Name(s)
Computerized cognitive training (CCT) using EndeavorRx
Intervention Description
The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management.
~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks
Primary Outcome Measure Information:
Title
Change in depressive symptoms as measured by Children's Depression Inventory (CDI)
Description
Self-report, 28 item scale on depressive symptoms. Total scores on this measure range from 0 to 54. Higher scores indicate worse depressive symptoms.
Time Frame
Baseline, following intervention (approximately 5 weeks)
Title
Change in cognitive control capacity NIH toolbox cognition composite score
Time Frame
Baseline, following intervention (approximately 5 weeks)
Secondary Outcome Measure Information:
Title
Depressive symptoms as measured by CDI
Description
Self-report, 28 item scale on depressive symptoms. Total scores on this measure range from 0 to 54. Higher scores indicate worse depressive symptoms.
Time Frame
Up to 5 months
Title
Cognitive control capacity as measured by NIH toolbox (NIHTB) cognition composite score
Description
The NIHTB (NIHTB) cognitive battery consists of 10 tasks and can be administered in 40 min. The scores can be evaluated separately, or they can be combined into composite scores: crystallized cognition composite (reflecting the ability to access information from long-term memory and general knowledge), fluid cognition composite (reflecting the processing ability to adapt to novel environment and solve problems), and overall cognitive function composite (a combination of both crystallized and fluid scores).
Time Frame
Up to 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant is willing to engage in a technology-based intervention (technology will be provided if not already accessible to participant).
Self-reported depressive symptoms
Participants will be required to maintain a stable dose of medications for 4 weeks prior to the first assessment
Exclusion Criteria:
Color blindness
Unable to play the video game for any reason
The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnosis of clinical depression, psychosis, or Autism Spectrum Disorder
Enrolled in current psychotherapy
Endorses any item on the Columbia Suicide Severity Rating Scale (C-SSRS) (has present suicidal ideation)
Has had any changes to their medication in the 4-weeks prior to study enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Becker, M.S.
Phone
734-764-2580
Email
hcbecker@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah Becker, M.S.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Becker, M.S.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
contact
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Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
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