Computerized Cognitive Training in Young Adults With Depression

Not Applicable

Terminated

• Conditions: Depressive Symptoms
• Interventions: Other: Computerized Cognitive Training; Other: Control

• Registration Number: NCT03869463
• Lead Sponsor: Queens College, The City University of New York

Brief Summary

The purpose of the study is to examine the benefits and mechanism of action of computerized cognitive training (CCT) on mood, neuropsychological deficits, everyday functioning, and brain activity among young adults with a range of depressive symptoms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Study Start: 2019-10-11
• Status Verified: 2022-09
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Age 18-29.

2. Current diagnosis of MDD/persistent depressive disorder or HDRS greater than or equal to 12. 3. Daily access to smartphone or tablet with internet connection for the study duration.

3. Willing and able to complete MRI, mood, and neuropsychological testing. 5. IQ > 85.

Exclusion Criteria

1. Lacks English-speaking ability as determined by self-report and clinical evaluation.
2. Evidence of schizophrenia, schizoaffective disorder, psychosis, bipolar I and II disorder.
3. Active suicidal ideation, intent, or plan, or past attempt within 1 year.
4. Severe depression (HDRS > 30).
5. Neurological disorder (epilepsy, multiple sclerosis, traumatic brain injury, clinical stroke).
6. Use of medications known to have negative impact on cognition (benzodiazepines and lorazepam equivalents > 1mg daily, narcotics, anticholinergics).
7. History of alcohol or drug abuse or dependence within past year.
8. Acute, severe, unstable medical illness. For cancer, acutely ill patients (including those with metastases) are excluded, but past history of successfully treated cancer does not result in exclusion.
9. Regular online brain training or regular player of non-fluency verbal games, defined as doing these procedures at a frequency of twice weekly or greater during the year prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EF/PS CCT	Computerized Cognitive Training	This group will complete EF/PS (executive functioning/processing speed) computerized cognitive training (CCT) which includes games specifically focused on executive function \& processing speed.
Verbal CCT	Computerized Cognitive Training	This group will complete verbal-focused computerized cognitive training.
Waitlist Control	Control	This group will not receive cognitive training during study participation.

Primary Outcome Measures

Name	Time	Method
Change in Emotional Go/No Go Task (fMRI)	Week 0, Week 4 or Week 8 (depending on randomization)	Measure of behavioral inhibition and set shifting. Participants must press a button for pre-specified to go trials and withhold pressing the button for pre-specified no-go trials.
Change in Sheehan Disability Scale	Screen, Week 0, Week 4, Week 8, 3-month follow-up	Self-report questionnaire of everyday functioning. It includes three subscales: work, social life, leisure activities, and home life or family responsibilities. Each subscale is rated on a 10-point scale for a minimum total score of 0 and a maximum total summed score of 30 across the three subscales. High scores are associated with more impairment.
Change in Hamilton Depression Rating Scale	Screen, Week 0, Week 4, Week 8, 3-month follow-up	Clinician-rated measure of depression composed of 21 questions. The first 17 items are scored: eight items have a 5-point scale, nine items have a 3-point scale. Total score range is 0-52. Higher scores indicate more severe symptoms.
Change in DKEFS Trail Making Test - Condition 4	Weeks 0, 4, 8, 3-month follow- up	Measure of executive function. It is a switching task that requires the subject to connect numbers and letters in an alternating pattern (1-A-2-B, etc.) as quickly as possible.

Secondary Outcome Measures

Name	Time	Method
Change in Beck Depression Inventory-II	Screen, weekly for weeks 0-8, 3-month follow-up	Self-report questionnaire of depression composed of 21 questions on a 4-point scale. Total score ranges from 0-63. Higher scores indicate worse symptom severity.
Change in WAIS-IV Coding	Weeks 0, 4, 8, 3-month follow- up	Participants are required to copy symbols paired with numbers in a 120 second time limit. The score is the number correct in the allotted time.
Change in Connectivity Index (resting state fMRI)	Week 0, Week 4 or Week 8 (depending on randomization)	Measure of resting state fMRI. Higher scores indicate more connectivity within the network

Trial Locations

Locations (1)

Queens College; 🇺🇸 New York, New York, United States