N/A
N=20
Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
Depression · Subclinical Depressive Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT05697627 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI) — 8.85; 5.84 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Computerized cognitive training (CCT) using EndeavorRx (Device)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI) |
8.85; 5.84 | — |
| PRIMARY Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) |
30.00; 24.05 | — |
| PRIMARY Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop |
1019.44; 1018.28 | — |
| PRIMARY Change in Cognitive Control Capacity - Conflict RT Stroop |
65.95; 62.32 | — |
| PRIMARY Change in Cognitive Control Capacity - Overall RT Flanker |
785.93; 778.62 | — |
| PRIMARY Change in Cognitive Control Capacity - Conflict RT Flanker |
151.31; 311.82 | — |
| SECONDARY Children's Depression Inventory (CDI) at Third Timepoint |
6.30 | — |
| SECONDARY Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint |
23.27 | — |
| SECONDARY Cognitive Control Capacity - Overall Reaction Time (RT) Stroop |
982.60 | — |
| SECONDARY Cognitive Control Capacity - Conflict RT Stroop |
58.45 | — |
| SECONDARY Cognitive Control Capacity - Overall RT Flanker |
597.31 | — |
| SECONDARY Cognitive Control Capacity - Conflict RT Flanker |
122.58 | — |
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. 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05697627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.