CClinicalTrials.gg
TerminatedNCT03869463Updated Sep 25, 2023

Computerized Cognitive Training in Young Adults With Depression

An interventional study of Computerized Cognitive Training and Control in Depressive Symptoms, sponsored by Queens College, The City University of New York. Terminated at 1 site in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-25.

Sponsored by Queens College, The City University of New York · Not applicable, Interventional, and Other

Why this study was terminated
Challenges to recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 29 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Depressive Symptoms

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 28 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Queens College, The City University of New York is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    EF/PS CCT

    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

  • Active comparator
    Verbal CCT

    This group will complete verbal-focused computerized cognitive training.

    Other: Computerized Cognitive Training

  • Placebo comparator
    Waitlist Control

    This group will not receive cognitive training during study participation.

    Other: Control

Interventions

  • OtherComputerized Cognitive Training

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

  • OtherControl

    This group will not receive computerized cognitive training.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Screen, Week 0, Week 4, Week 8, 3-month follow-up

  2. 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.

    Time frame: Screen, Week 0, Week 4, Week 8, 3-month follow-up

  3. 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.

    Time frame: Weeks 0, 4, 8, 3-month follow- up

  4. 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.

    Time frame: Week 0, Week 4 or Week 8 (depending on randomization)

Secondary outcomes

  1. Change in Beck Depression Inventory-II

    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.

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

  2. Change in WAIS-IV Coding

    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.

    Time frame: Weeks 0, 4, 8, 3-month follow- up

  3. Change in Connectivity Index (resting state fMRI)

    Measure of resting state fMRI. Higher scores indicate more connectivity within the network

    Time frame: Week 0, Week 4 or Week 8 (depending on randomization)

Other outcomes

  1. Change in DKEFS Trail Making Test - Condition 2

    Measure of processing speed. This is a paper and pencil test requiring subjects to connect in order 25 encircled numbers randomly arranged using pencil lines.

    Time frame: Weeks 0, 4, 8, 3-month follow- up

  2. Change in DKEFS Color-Word Interference Test

    Measure of response inhibition. This test is divided into four sections: color naming, word reading, color-word inhibition, and color-word inhibition/ switching. The score in each condition is the completion time as well as the number of errors and self-corrections.

    Time frame: Weeks 0, 4, 8, 3-month follow- up

  3. Change in WAIS-IV Digit Span Forwards

    Measure of attention. This test requires participants to repeat back strings of digits in the same order in which they heard them.

    Time frame: Weeks 0, 4, 8, 3-month follow- up

  4. Change in WAIS-IV Digit Span Backwards

    Measure of working memory. This test requires participants to repeat back strings of digits in the reverse order in which they heard them.

    Time frame: Weeks 0, 4, 8, 3-month follow- up

  5. Change in WAIS-IV Symbol Search

    Measure of processing speed. Subjects are required to visually scan and mark off the same object as a target stimulus among a set of distractors in a 120 second time limit.

    Time frame: Weeks 0, 4, 8, 3-month follow- up

  6. Change in DKEFS Letter and Category Naming Test

    Measure of verbal fluency. This test requires subjects to generate words that begin with a particular letter or belong to a particular semantic category as quickly as possible. Total score is the number of words generated in 60 seconds per trial.

    Time frame: Weeks 0, 4, 8, 3-month follow- up

  7. Change in California Verbal Learning Test-II

    Measure of short-term and long-term verbal memory. For this test, the participant is read a list of words five times. He/she is asked to recall what was on the list immediately after each reading of the list. After a delay, the participant is again asked to recall what words were on the list.

    Time frame: Weeks 0, 4, 8, 3-month follow- up

  8. Change in Brief Visuospatial Memory Test-Revised

    Measure of visual spatial memory. Subjects reproduce a series of six designs on paper, visually presented for 10 seconds on three trials. After a delay, the subject is asked to recall the presented designs again.

    Time frame: Weeks 0, 4, 8, 3-month follow- up

07

Study locations

1 site
  • Queens College
    New York, New York 11367, United States
08

References and documents

Publications

  • 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. PubMed 32743079 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03869463
Lead sponsor
Queens College, The City University of New York
Responsible party
Sponsor
First posted
Mar 11, 2019
Start date
Oct 11, 2019
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023
Last update
Sep 25, 2023

Study contacts

Joel R Sneed, PhD
principal investigator · Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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