Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2024-08-05

Brief Summary

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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.

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Detailed Description

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

Conditions

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Depression Subclinical Depressive Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Computerized cognitive training (CCT) using EndeavorRx

Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory.

Group Type EXPERIMENTAL

Computerized cognitive training (CCT) using EndeavorRx

Intervention Type DEVICE

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

Interventions

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Computerized cognitive training (CCT) using EndeavorRx

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

9 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No