Computerized Cognitive Training in Young Adults With Depression

Sponsor
Queens College, The City University of New York (Other)
Overall Status
Recruiting
CT.gov ID
NCT03869463
Collaborator
(none)
90
1
3
28.6
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Computerized Cognitive Training
  • Other: Control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Testing the Mechanism of Action of Computerized Cognitive Training in Young Adults With Depression: Clinical, Cognitive and Neuroimaging Outcomes
Actual Study Start Date :
Oct 11, 2019
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

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

Active Comparator: Verbal CCT

This group will complete verbal-focused computerized cognitive training.

Other: Computerized Cognitive Training
Participants will complete 8 weeks of computerized cognitive training through the Peak platform on mobile devices.

Placebo Comparator: Waitlist Control

This group will not receive cognitive training during study participation.

Other: Control
This group will not receive computerized cognitive training.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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

Other Outcome Measures

  1. Change in DKEFS Trail Making Test - Condition 2 [Weeks 0, 4, 8, 3-month follow- up]

    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.

  2. Change in DKEFS Color-Word Interference Test [Weeks 0, 4, 8, 3-month follow- up]

    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.

  3. Change in WAIS-IV Digit Span Forwards [Weeks 0, 4, 8, 3-month follow- up]

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

  4. Change in WAIS-IV Digit Span Backwards [Weeks 0, 4, 8, 3-month follow- up]

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

  5. Change in WAIS-IV Symbol Search [Weeks 0, 4, 8, 3-month follow- up]

    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.

  6. Change in DKEFS Letter and Category Naming Test [Weeks 0, 4, 8, 3-month follow- up]

    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.

  7. Change in California Verbal Learning Test-II [Weeks 0, 4, 8, 3-month follow- up]

    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.

  8. Change in Brief Visuospatial Memory Test-Revised [Weeks 0, 4, 8, 3-month follow- up]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 29 Years
Sexes Eligible for Study:
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.

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queens College New York New York United States 11367

Sponsors and Collaborators

  • Queens College, The City University of New York

Investigators

  • Principal Investigator: Joel R Sneed, PhD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Queens College, The City University of New York
ClinicalTrials.gov Identifier:
NCT03869463
Other Study ID Numbers:
  • 2018-1311
First Posted:
Mar 11, 2019
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2020