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Completed

NCT Number: NCT05697627

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.

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Key information

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study.
  • Males and females (age 9 - 17.99)
  • 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).
  • Self-reported depressive symptoms (Children's Depression Inventory [CDI] score between 3-19 at Assessment 1)
  • Participants will be required to maintain a stable dose of medications

Exclusion criteria

  • Color blindness
  • Unable to play the video game for any reason
  • Current Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnosis of clinical depression, psychosis, or Autism Spectrum Disorder
  • 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
  • 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.
  • Has had any changes to their medication in the 4-weeks prior to study enrollment

Treatment and study plan

Computerized cognitive training (CCT) using EndeavorRx

Device

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 outcomes

  1. Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)

    Time frame: Baseline and approximately 5 weeks after

    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.

  2. Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R)

    Time frame: Baseline and approximately 5 weeks after

    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.

  3. Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop

    Time frame: Baseline and approximately 5 weeks after

    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.

  4. Change in Cognitive Control Capacity - Conflict RT Stroop

    Time frame: Baseline and approximately 5 weeks after

    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.

  5. Change in Cognitive Control Capacity - Overall RT Flanker

    Time frame: Baseline and approximately 5 weeks after

    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.

  6. Change in Cognitive Control Capacity - Conflict RT Flanker

    Time frame: Baseline and approximately 5 weeks after

    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.

Secondary outcomes

  1. Children's Depression Inventory (CDI) at Third Timepoint

    Time frame: Up to 4 months

    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.

  2. Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint

    Time frame: Up to 4 months

    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.

  3. Cognitive Control Capacity - Overall Reaction Time (RT) Stroop

    Time frame: Up to 4 months

    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.

  4. Cognitive Control Capacity - Conflict RT Stroop

    Time frame: Up to 4 months

    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.

  5. Cognitive Control Capacity - Overall RT Flanker

    Time frame: Up to 4 months

    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.

  6. Cognitive Control Capacity - Conflict RT Flanker

    Time frame: Up to 4 months

    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.

Other outcomes

  1. Feasibility/Acceptability and Experimental Outcome

    Time frame: Up to 4 months

    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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2023
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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