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Clinical Trials/NCT05697627
NCT05697627
Completed
Not Applicable

Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth

University of Michigan1 site in 1 country31 target enrollmentMay 3, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Michigan
Enrollment
31
Locations
1
Primary Endpoint
Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 3, 2023
End Date
August 5, 2024
Last Updated
10 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hannah Becker, MS

Doctoral Candidate in Clinical Science

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Children's Depression Inventory (CDI) at Third Timepoint(Up to 4 months)
  • Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint(Up to 4 months)
  • Cognitive Control Capacity - Overall Reaction Time (RT) Stroop(Up to 4 months)
  • Cognitive Control Capacity - Conflict RT Stroop(Up to 4 months)
  • Cognitive Control Capacity - Overall RT Flanker(Up to 4 months)
  • Cognitive Control Capacity - Conflict RT Flanker(Up to 4 months)

Study Sites (1)

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