Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth

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, this information will be used to try to improve prevention of the development of depression, so that it can help more patients.

Study Overview

• Status: Completed
• Conditions: Depression; Subclinical Depressive Symptoms
• Intervention / Treatment: Device: Computerized cognitive training (CCT) using EndeavorRx

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study.
2. Males and females (age 9 - 17.99)
3. Participant is willing to engage in a technology-based intervention (technology will be provided to participants who live in the state of Michigan, if not already accessible to participant).
4. Self-reported depressive symptoms (Children's Depression Inventory [CDI] score between 3-19 at Assessment 1)
5. Participants will be required to maintain a stable dose of medications

EXCLUSION CRITERIA

1. Color blindness
2. Unable to play the video game for any reason
3. Current Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnosis of clinical depression, psychosis, or Autism Spectrum Disorder
4. Has enrolled in new psychotherapy (for the treatment of a mood or anxiety disorder) or had changes to their psychotherapy in the 4-weeks prior to study enrollment
5. Endorses items #1, #2, #3, #4, #5, or #6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screener (Past-Month); i.e., has present suicidal intention/behavior.
6. Has had any changes to their medication in the 4-weeks prior to study enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computerized cognitive training (CCT) using EndeavorRx; Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)	The CDI was a self-report, 27 item scale used to measure depressive symptoms. Total scores on the CDI ranged from 0 (no depressive symptoms) to 54 (extremely severe depressive symptoms). Higher scores indicated worse depressive symptoms. CDI scores were collected from participants at three timepoints: 1) baseline, 2) approximately 5 weeks after baseline, and 3) up to 4 months after baseline. Results reflect CDI scores collected at the first and second timepoints.	Baseline and approximately 5 weeks after
Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R)	The CDRS-R is a clinician-administered tool used to assess the severity of depression in children and adolescents based on a 17-item scale of depressive symptoms. Total raw scores on this scale range from 17-113, with 17 indicating no or minimal depressive symptoms and 113 indicating extremely severe symptoms of depression. CDRS-R scores were collected from participants at three timepoints: 1) baseline, 2) approximately 5 weeks after baseline, and 3) up to 4 months after baseline. Results reflect CDRS-R scores collected at the first and second timepoints.	Baseline and approximately 5 weeks after
Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop	The Stroop task assesses cognitive control and emotion regulation over emotional information processing by measuring how quickly individuals name the ink color of words that are emotionally-charged or neutral. For this measure, lower scores indicated better performance, i.e., better cognitive control and emotion regulation. Results reflect the average reaction time across all trials of the Stroop task that participants completed.	Baseline and approximately 5 weeks after
Change in Cognitive Control Capacity - Conflict RT Stroop	The Stroop task assesses cognitive control and emotion regulation over emotional information processing by measuring how quickly individuals name the ink color of words that are emotionally-charged or neutral. For this measure, lower scores indicated better performance, i.e., better cognitive control and emotion regulation. Results reflect the difference in the reaction time between incongruent trials and congruent trials on the Stroop task.	Baseline and approximately 5 weeks after
Change in Cognitive Control Capacity - Overall RT Flanker	The Flanker task is a psychological experiment that assesses a person's ability to focus on a target stimulus while ignoring distracting stimuli. For this measure, higher scores indicate better performance. Results reflect the average reaction time across all trials of the Flanker task that participants completed at this timepoint.	Baseline and approximately 5 weeks after
Change in Cognitive Control Capacity - Conflict RT Flanker	The Flanker task is a psychological experiment that assesses a person's ability to focus on a target stimulus while ignoring distracting stimuli. For this measure, higher scores indicate better performance. Results reflect the difference in the reaction time between incongruent trials and congruent trials of the Flanker task.	Baseline and approximately 5 weeks after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Depression Inventory (CDI) at Third Timepoint	The CDI was a self-report, 27 item scale used to measure depressive symptoms. Total scores on the CDI ranged from 0 (no depressive symptoms) to 54 (extremely severe depressive symptoms). Higher scores indicated worse depressive symptoms. CDI scores were collected from participants at three timepoints: 1) baseline, 2) approximately 5 weeks after baseline, and 3) up to 4 months after baseline. Results reflect CDI scores collected at the third timepoint.	Up to 4 months
Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint	The CDRS-R is a clinician-administered tool used to assess the severity of depression in children and adolescents based on a 17-item scale of depressive symptoms. Total raw scores on this scale range from 17-113, with 17 indicating no or minimal depressive symptoms and 113 indicating extremely severe symptoms of depression. CDRS-R scores were collected from participants at three timepoints: 1) baseline, 2) approximately 5 weeks after baseline, and 3) up to 4 months after baseline. Results reflect CDRS-R scores collected at the third timepoint.	Up to 4 months
Cognitive Control Capacity - Overall Reaction Time (RT) Stroop	The Stroop task assesses cognitive control and emotion regulation over emotional information processing by measuring how quickly individuals name the ink color of words that are emotionally-charged or neutral. For this measure, lower scores indicated better performance, i.e., better cognitive control and emotion regulation. Results reflect the average reaction time across all trials of the Stroop task that participants completed at this timepoint.	Up to 4 months
Cognitive Control Capacity - Conflict RT Stroop	The Stroop task assesses cognitive control and emotion regulation over emotional information processing by measuring how quickly individuals name the ink color of words that are emotionally-charged or neutral. For this measure, lower scores indicated better performance, i.e., better cognitive control and emotion regulation. Results reflect the difference in the reaction time between incongruent trials and congruent trials on the Stroop task.	Up to 4 months
Cognitive Control Capacity - Overall RT Flanker	The Flanker task is a psychological experiment that assesses a person's ability to focus on a target stimulus while ignoring distracting stimuli. For this measure, higher scores indicate better performance. Results reflect the average reaction time across all trials of the Flanker task that participants completed at this timepoint.	Up to 4 months
Cognitive Control Capacity - Conflict RT Flanker	The Flanker task is a psychological experiment that assesses a person's ability to focus on a target stimulus while ignoring distracting stimuli. For this measure, higher scores indicate better performance. Results reflect the difference in the reaction time between incongruent trials and congruent trials on the Flanker task.	Up to 4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility/Acceptability and Experimental Outcome	Outcome measures that indicate how much the video game was played and acceptability of the game as indicated by self-report ratings. Includes: gameplay metrics from the video game (total amount of missions completed across the 4-weeks of the intervention), Endeavor Satisfaction Survey Scores (Scale 1-5 (3 is neutral) on each item; parent and child report), and depressive symptoms at baseline (Children's Depression Inventory).	Up to 4 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Hannah Becker, M.S., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): August 5, 2024

Study Registration Dates

• First Submitted: January 7, 2023
• First Submitted That Met QC Criteria: January 21, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 14, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive Training Video Game
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: HUM00227345

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: contact

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes