Trial Outcomes & Findings for Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth (NCT NCT05697627)

NCT ID: NCT05697627

Last Updated: 2025-06-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Baseline and approximately 5 weeks after
• Results posted on: 2025-06-18

Participant Flow

31 participants signed consent forms. During the pre-assignment phase of the study, participants completed several diagnostic and clinical assessments to see if they met eligibility criteria. 11 of these 31 individuals were not assigned to the intervention because of the following: did not meet eligibility criteria (n=9); lost to follow-up during pre-assignment (n=1); the study concluded prior to the assignment phase for this individual (n=1).

Participant milestones

Measure	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. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Overall Study Adverse Event	1

Baseline Characteristics

Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth

Baseline characteristics by cohort

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=20 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants were instructed to engage in approximately 25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Age, Continuous	11.9 years STANDARD_DEVIATION 1.92 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and approximately 5 weeks after

Population: One participant dropped out of the study before the follow-up assessment.

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.

Outcome measures

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=20 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI) Baseline CDI scores	8.85 score on a scale Standard Deviation 3.65
Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI) Approximately 5 weeks	5.84 score on a scale Standard Deviation 4.37

PRIMARY outcome

Timeframe: Baseline and approximately 5 weeks after

Population: One participant dropped out of the study before the 5-week assessment.

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.

Outcome measures

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=20 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) Baseline - Raw CDRS-R scores	30.00 score on a scale Standard Deviation 5.69
Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) Approximately 5 weeks - Raw CDRS-R scores	24.05 score on a scale Standard Deviation 3.29

PRIMARY outcome

Timeframe: Baseline and approximately 5 weeks after

Population: 1 person did not complete the baseline cognitive assessment and also withdrew prior to follow-up assessment.

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.

Outcome measures

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=19 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop Overall RT on Stroop Task pre-intervention	1019.44 milliseconds Standard Deviation 131.07
Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop Overall RT on Stroop Task post-intervention	1018.28 milliseconds Standard Deviation 140.31

PRIMARY outcome

Timeframe: Baseline and approximately 5 weeks after

Population: 1 person did not complete the baseline cognitive assessment and also withdrew prior to follow-up assessment.

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.

Outcome measures

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=19 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Change in Cognitive Control Capacity - Conflict RT Stroop Conflict RT (Incongruent Trial RT - Congruent Trial RT) on Stroop Task pre-intervention	65.95 milliseconds Standard Deviation 58.60
Change in Cognitive Control Capacity - Conflict RT Stroop Conflict RT (Incongruent Trial RT - Congruent Trial RT) on Stroop Task post-intervention	62.32 milliseconds Standard Deviation 96.70

PRIMARY outcome

Timeframe: Baseline and approximately 5 weeks after

Population: Only 19 participants completed any of the cognitive tasks at baseline or follow up. From the 19, 2 participants at pre-intervention did not complete the Flanker task. From the 19, 1 participant at post-intervention did not complete the Flanker task.

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.

Outcome measures

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=18 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Change in Cognitive Control Capacity - Overall RT Flanker Overall RT on Flanker Task pre-intervention	785.93 milliseconds Standard Deviation 266.25
Change in Cognitive Control Capacity - Overall RT Flanker Overall RT on Flanker Task post-intervention	778.62 milliseconds Standard Deviation 435.33

PRIMARY outcome

Timeframe: Baseline and approximately 5 weeks after

Population: Only 19 participants completed any of the cognitive tasks at baseline or follow up. From the 19, 2 participants at pre-intervention did not complete the Flanker task. From the 19, 1 participant at post-intervention did not complete the Flanker task.

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.

Outcome measures

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=18 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Change in Cognitive Control Capacity - Conflict RT Flanker Conflict RT (Incongruent Trial RT - Congruent Trial RT) on Flanker Task post-intervention	311.82 milliseconds Standard Deviation 970.06
Change in Cognitive Control Capacity - Conflict RT Flanker Conflict RT (Incongruent Trial RT - Congruent Trial RT) on Flanker Task pre-intervention	151.31 milliseconds Standard Deviation 188.11

SECONDARY outcome

Timeframe: Up to 4 months

Population: The third timepoint was offered as optional to participants and then eventually removed from the protocol altogether. 10 participants returned and completed the CDI at the optional third time point.

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.

Outcome measures

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=10 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Children's Depression Inventory (CDI) at Third Timepoint	6.30 score on a scale Standard Deviation 6.48

SECONDARY outcome

Timeframe: Up to 4 months

Population: The third timepoint was offered as optional to participants and then eventually removed from the protocol altogether. 11 participants returned to complete the CDRS-R for the optional 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.

Outcome measures

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=11 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint	23.27 score on a scale Standard Deviation 3.82

SECONDARY outcome

Timeframe: Up to 4 months

Population: The third timepoint was offered as optional to participants and then eventually removed from the protocol altogether. 11 participants completed the third timepoint assessment, and 6 participants completed the cognitive tasks at this timepoint (including 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.

Outcome measures

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=6 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Cognitive Control Capacity - Overall Reaction Time (RT) Stroop	982.60 milliseconds Standard Deviation 70.39

SECONDARY outcome

Timeframe: Up to 4 months

Population: The third timepoint was offered as optional to participants and then eventually removed from the protocol altogether. 11 participants completed the third timepoint assessment, and 6 participants completed the cognitive tasks at this timepoint (including 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.

Outcome measures

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=6 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Cognitive Control Capacity - Conflict RT Stroop	58.45 milliseconds Standard Deviation 76.85

SECONDARY outcome

Timeframe: Up to 4 months

Population: The third timepoint was offered as optional to participants and then eventually removed from the protocol altogether. 11 participants completed the third timepoint assessment, and 6 participants completed the cognitive tasks at this timepoint (including 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.

Outcome measures

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=6 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Cognitive Control Capacity - Overall RT Flanker	597.31 milliseconds Standard Deviation 93.90

SECONDARY outcome

Timeframe: Up to 4 months

Population: The third timepoint was offered as optional to participants and then eventually removed from the protocol altogether. 11 participants completed the third timepoint assessment, and 6 participants completed the cognitive tasks at this timepoint (including 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.

Outcome measures

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=6 Participants The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants engage in approximately \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Cognitive Control Capacity - Conflict RT Flanker	122.58 milliseconds Standard Deviation 39.81

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

Adverse Events

Computerized Cognitive Training (CCT) Using EndeavorRx

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Computerized Cognitive Training (CCT) Using EndeavorRx n=20 participants at risk The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. Participants were instructed to engage in approximately 25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.
Musculoskeletal and connective tissue disorders Minor neck pain	5.0% 1/20 • Number of events 1 • Up to 6 months
Respiratory, thoracic and mediastinal disorders Common cold	5.0% 1/20 • Number of events 1 • Up to 6 months
Respiratory, thoracic and mediastinal disorders Flu	10.0% 2/20 • Number of events 2 • Up to 6 months
Psychiatric disorders Increase of depressive symptoms >25% on CDI from T1 to T2	5.0% 1/20 • Number of events 1 • Up to 6 months
Psychiatric disorders Increase of depression symptoms >25% on CDI from T1 to T3	10.0% 2/20 • Number of events 2 • Up to 6 months

Additional Information

Hannah Becker

University of Michigan

Phone: (734) 764-2580

Email: hcbecker@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place