Computerized Cognitive Training in Young Adults With Depression

NCT03869463 | Terminated

• 1 other identifier: 2018-1311
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (4)

• Change in Sheehan Disability Scale

  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.

  Screen, Week 0, Week 4, Week 8, 3-month follow-up

• Change in Hamilton Depression Rating Scale

  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.

  Screen, Week 0, Week 4, Week 8, 3-month follow-up

• Change in DKEFS Trail Making Test - Condition 4

  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.

  Weeks 0, 4, 8, 3-month follow- up

• Change in Emotional Go/No Go Task (fMRI)

  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.

  Week 0, Week 4 or Week 8 (depending on randomization)

Secondary Outcomes (3)

• Change in Beck Depression Inventory-II

  Screen, weekly for weeks 0-8, 3-month follow-up

• Change in WAIS-IV Coding

  Weeks 0, 4, 8, 3-month follow- up

• Change in Connectivity Index (resting state fMRI)

  Week 0, Week 4 or Week 8 (depending on randomization)

Other Outcomes (8)

• Change in DKEFS Trail Making Test - Condition 2

  Weeks 0, 4, 8, 3-month follow- up

• Change in DKEFS Color-Word Interference Test

  Weeks 0, 4, 8, 3-month follow- up

• Change in WAIS-IV Digit Span Forwards

  Weeks 0, 4, 8, 3-month follow- up

Study Arms (3)

EF/PS CCT

EXPERIMENTAL

This group will complete EF/PS (executive functioning/processing speed) computerized cognitive training (CCT) which includes games specifically focused on executive function \& processing speed.

Other: Computerized Cognitive Training

Verbal CCT

ACTIVE COMPARATOR

This group will complete verbal-focused computerized cognitive training.

Other: Computerized Cognitive Training

Waitlist Control

PLACEBO COMPARATOR

This group will not receive cognitive training during study participation.

Other: Control

Interventions

Computerized Cognitive Training OTHER

Participants will complete 8 weeks of computerized cognitive training through the Peak platform on mobile devices.

EF/PS CCT; Verbal CCT

Control OTHER

This group will not receive computerized cognitive training.

Waitlist Control

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-29.
• 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.
• \. Willing and able to complete MRI, mood, and neuropsychological testing. 5. IQ \> 85.

You may not qualify if:

• Lacks English-speaking ability as determined by self-report and clinical evaluation.
• Evidence of schizophrenia, schizoaffective disorder, psychosis, bipolar I and II disorder.
• Active suicidal ideation, intent, or plan, or past attempt within 1 year.
• Severe depression (HDRS \> 30).
• Neurological disorder (epilepsy, multiple sclerosis, traumatic brain injury, clinical stroke).
• Use of medications known to have negative impact on cognition (benzodiazepines and lorazepam equivalents \> 1mg daily, narcotics, anticholinergics).
• History of alcohol or drug abuse or dependence within past year.
• 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.

Sponsors & Collaborators

• Queens College, The City University of New York: lead

Study Sites (1)

Queens College

New York, New York, 11367, United States

Location

Related Publications (1)

• Rushia SN, Schiff S, Egglefield DA, Motter JN, Grinberg A, Saldana DG, Shehab AAS, Fan J, Sneed JR. Testing the Mechanism of Action of Computerized Cognitive Training in Young Adults with Depression: Protocol for a Blinded, Randomized, Controlled Treatment Trial. J Psychiatr Brain Sci. 2020;5:e200014. doi: 10.20900/jpbs.20200014. Epub 2020 Jun 19.

  PMID: 32743079 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Joel R Sneed, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: March 11, 2019
• Study Start: October 11, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: September 25, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)