DepressionNCT05697627
Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
A study testing Computerized cognitive training (CCT) using EndeavorRx in people with Depression and Subclinical Depressive Symptoms, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Depression, Subclinical Depressive Symptoms
- What is being tested?
- Computerized cognitive training (CCT) using EndeavorRx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2023to 5 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The primary study investigator acknowledges contributions from Kate Fitzgerald, Emily Bilek, Christopher Monk, and Adriene Beltz.
- Conditions
- Depression, Subclinical Depressive Symptoms
- Being tested
- Computerized cognitive training (CCT) using EndeavorRx
- Keywords
- Cognitive Training Video Game
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive training (CCT) using EndeavorRxDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Computerized cognitive training (CCT) using EndeavorRx | Experimental | Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory. Receives: Device: Computerized cognitive training (CCT) using EndeavorRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and approximately 5 weeks after
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start3 May 2023
- Primary completion1 Jul 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Becker, MS, University of Michigan
- Investigators
- Hannah Becker, M.S., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697627
- Sponsor's protocol ID
- HUM00227345
- Status last verified
- Jun 2025
- First submitted
- 7 Jan 2023
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: contact
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
- ClinicalTrials.gov ID
- NCT05697627
- Acronym / sponsor ID
- HUM00227345
- Conditions
- Depression, Subclinical Depressive Symptoms
- Keywords
- Cognitive Training Video Game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Posted 18 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary study investigator acknowledges contributions from Kate Fitzgerald, Emily Bilek, Christopher Monk, and Adriene Beltz.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerized cognitive training (CCT) using EndeavorRx | Experimental | Device: Computerized cognitive training (CCT) using EndeavorRxExciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized cognitive training (CCT) using EndeavorRxThe 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 | Device | Computerized cognitive training (CCT) using EndeavorRx |
Primary outcome
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Children's Depression Inventory (CDI) at Third Timepoint
Time frame: Up to 4 months
Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint
Time frame: Up to 4 months
Cognitive Control Capacity - Overall Reaction Time (RT) Stroop
Time frame: Up to 4 months
Cognitive Control Capacity - Conflict RT Stroop
Time frame: Up to 4 months
Cognitive Control Capacity - Overall RT Flanker
Time frame: Up to 4 months
Cognitive Control Capacity - Conflict RT Flanker
Time frame: Up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. contact
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Becker, M.S. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized cognitive training (CCT) using EndeavorRx in people with Depression and Subclinical Depressive Symptoms, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI) (time frame: Baseline and approximately 5 weeks after). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.