Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth

Depression Clinical Trial

Official title:

Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05697627
• Other study ID #: HUM00227345
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Hannah Becker, M.S.
• Phone: 734-764-2580
• Email: hcbecker[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The primary study investigator acknowledges contributions from Kate Fitzgerald, Emily Bilek, Christopher Monk, and Adriene Beltz.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Device:
• Computerized cognitive training (CCT) using EndeavorRx
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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, following intervention (approximately 5 weeks)
Primary	Change in cognitive control capacity NIH toolbox cognition composite score		Baseline, following intervention (approximately 5 weeks)
Secondary	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.	Up to 5 months
Secondary	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).	Up to 5 months