Depression Clinical Trial
Official title:
Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
NCT number | NCT05697627 |
Other study ID # | HUM00227345 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 3, 2023 |
Est. completion date | August 2024 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 17 Years |
Eligibility | 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 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 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. #6 on the 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in depressive symptoms as measured by Children's Depression Inventory (CDI) | Self-report, 27 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 scores on several cognitive tasks administered through Inquisit Millisecond. These individual tasks are not part of a composite battery with standard scoring. | There are six different tasks in the non-standardized battery that assess different aspects of cognitive control and emotion regulation. Several tasks (2-3) with the least missingness and/or outliers will be selected to analyze, and task selection will be completed prior to analysis. For measures of reaction time, lower scores indicate better performance. For scores of accuracy, higher scores indicate better performance. | Baseline, following intervention (approximately 5 weeks) | |
Secondary | Depressive symptoms as measured by CDI | Self-report, 27 item scale on depressive symptoms. Total scores on this measure range from 0 to 54. Higher scores indicate worse depressive symptoms. | Up to 4 months | |
Secondary | Change in cognitive control scores on several cognitive tasks administered through Inquisit Millisecond. These individual tasks are not part of a composite battery with standard scoring. | There are six different tasks in the non-standardized battery that assess different aspects of cognitive control and emotion regulation. Several tasks (2-3) with the least missingness and/or outliers will be selected to analyze, and task selection will be completed prior to analysis. For measures of reaction time, lower scores indicate better performance. For scores of accuracy, higher scores indicate better performance. | Up to 4 months |
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