Clinical trial NCT05697627: Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
Official title: Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Subclinical Depressive Symptoms
Keywords: Cognitive Training Video Game
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 31
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Eligibility criteria: 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 (Children's Depression Inventory \[CDI\] score between 3-19 at Assessment 1)
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 Kiddie Schedule for Affective Disorders and Schizophrenia (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, or #6 on the Columbia Suicide Severity Rating Scale (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

Primary outcomes:
measure: Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)
timeFrame: Baseline and approximately 5 weeks after
measure: Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R)
timeFrame: Baseline and approximately 5 weeks after
measure: Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop
timeFrame: Baseline and approximately 5 weeks after
measure: Change in Cognitive Control Capacity - Conflict RT Stroop
timeFrame: Baseline and approximately 5 weeks after
measure: Change in Cognitive Control Capacity - Overall RT Flanker
timeFrame: Baseline and approximately 5 weeks after
measure: Change in Cognitive Control Capacity - Conflict RT Flanker
timeFrame: Baseline and approximately 5 weeks after
Secondary outcomes:
measure: Children's Depression Inventory (CDI) at Third Timepoint
timeFrame: Up to 4 months
measure: Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint
timeFrame: Up to 4 months
measure: Cognitive Control Capacity - Overall Reaction Time (RT) Stroop
timeFrame: Up to 4 months
measure: Cognitive Control Capacity - Conflict RT Stroop
timeFrame: Up to 4 months
measure: Cognitive Control Capacity - Overall RT Flanker
timeFrame: Up to 4 months
measure: Cognitive Control Capacity - Conflict RT Flanker
timeFrame: Up to 4 months
Other outcomes:
measure: Feasibility/Acceptability and Experimental Outcome
timeFrame: Up to 4 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hannah Becker, M.S.
role: PRINCIPAL_INVESTIGATOR
References: