Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth

Conditions

Depression, Subclinical Depressive Symptoms

Keywords

Cognitive Training Video Game

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.

Related papers

No related papers found yet.

Interventions

DEVICEComputerized 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

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

9 Years to 17 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)	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)	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	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	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	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	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

Measure	Time frame	Description
Cognitive Control Capacity - Conflict RT Flanker	Up to 4 months	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 on the Flanker task.
Children's Depression Inventory (CDI) at Third Timepoint	Up to 4 months	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 third timepoint.
Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint	Up to 4 months	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 third timepoint.
Cognitive Control Capacity - Overall Reaction Time (RT) Stroop	Up to 4 months	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 at this timepoint.
Cognitive Control Capacity - Conflict RT Stroop	Up to 4 months	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.
Cognitive Control Capacity - Overall RT Flanker	Up to 4 months	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.

Other

Measure	Time frame	Description
Feasibility/Acceptability and Experimental Outcome	Up to 4 months	Outcome measures that indicate how much the video game was played and acceptability of the game as indicated by self-report ratings. Includes: gameplay metrics from the video game (total amount of missions completed across the 4-weeks of the intervention), Endeavor Satisfaction Survey Scores (Scale 1-5 (3 is neutral) on each item; parent and child report), and depressive symptoms at baseline (Children's Depression Inventory).

Countries

United States

Participant flow

Pre-assignment details

31 participants signed consent forms. During the pre-assignment phase of the study, participants completed several diagnostic and clinical assessments to see if they met eligibility criteria. 11 of these 31 individuals were not assigned to the intervention because of the following: did not meet eligibility criteria (n=9); lost to follow-up during pre-assignment (n=1); the study concluded prior to the assignment phase for this individual (n=1).

Participants by arm

Arm	Count
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. Participants were instructed to engage in approximately 25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks.	20
Total	20

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1

Baseline characteristics

Characteristic	Computerized Cognitive Training (CCT) Using EndeavorRx
Age, Continuous	11.9 years STANDARD_DEVIATION 1.92
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	16 Participants
Region of Enrollment United States	20 participants
Sex: Female, Male Female	10 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 20
other Total, other adverse events	6 / 20
serious Total, serious adverse events	0 / 20

Outcome results

Primary

Change in Cognitive Control Capacity - Conflict RT Flanker

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.