- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03869463
Computerized Cognitive Training in Young Adults With Depression
September 21, 2023 updated by: Queens College, The City University of New York
Testing the Mechanism of Action of Computerized Cognitive Training in Young Adults With Depression: Clinical, Cognitive and Neuroimaging Outcomes
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Research Coordinator
- Phone Number: 718-997-3226
- Email: lifespandevelopmentlab@gmail.com
Study Locations
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New York
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New York, New York, United States, 11367
- Queens College
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
4. Willing and able to complete MRI, mood, and neuropsychological testing. 5. IQ > 85.
Exclusion Criteria:
- 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.
- 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.
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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Participants will complete 8 weeks of computerized cognitive training through the Peak platform on mobile devices.
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Active Comparator: Verbal CCT
This group will complete verbal-focused computerized cognitive training.
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Participants will complete 8 weeks of computerized cognitive training through the Peak platform on mobile devices.
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Placebo Comparator: Waitlist Control
This group will not receive cognitive training during study participation.
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This group will not receive computerized cognitive training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sheehan Disability Scale
Time Frame: Screen, Week 0, Week 4, Week 8, 3-month follow-up
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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.
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Screen, Week 0, Week 4, Week 8, 3-month follow-up
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Change in Hamilton Depression Rating Scale
Time Frame: 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.
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Screen, Week 0, Week 4, Week 8, 3-month follow-up
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Change in DKEFS Trail Making Test - Condition 4
Time Frame: Weeks 0, 4, 8, 3-month follow- up
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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.
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Weeks 0, 4, 8, 3-month follow- up
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Change in Emotional Go/No Go Task (fMRI)
Time Frame: Week 0, Week 4 or Week 8 (depending on randomization)
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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.
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Week 0, Week 4 or Week 8 (depending on randomization)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Beck Depression Inventory-II
Time Frame: Screen, weekly for weeks 0-8, 3-month follow-up
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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.
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Screen, weekly for weeks 0-8, 3-month follow-up
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Change in WAIS-IV Coding
Time Frame: Weeks 0, 4, 8, 3-month follow- up
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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.
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Weeks 0, 4, 8, 3-month follow- up
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Change in Connectivity Index (resting state fMRI)
Time Frame: Week 0, Week 4 or Week 8 (depending on randomization)
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Measure of resting state fMRI.
Higher scores indicate more connectivity within the network
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Week 0, Week 4 or Week 8 (depending on randomization)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in DKEFS Trail Making Test - Condition 2
Time Frame: Weeks 0, 4, 8, 3-month follow- up
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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.
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Weeks 0, 4, 8, 3-month follow- up
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Change in DKEFS Color-Word Interference Test
Time Frame: 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.
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Weeks 0, 4, 8, 3-month follow- up
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Change in WAIS-IV Digit Span Forwards
Time Frame: Weeks 0, 4, 8, 3-month follow- up
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Measure of attention.
This test requires participants to repeat back strings of digits in the same order in which they heard them.
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Weeks 0, 4, 8, 3-month follow- up
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Change in WAIS-IV Digit Span Backwards
Time Frame: Weeks 0, 4, 8, 3-month follow- up
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Measure of working memory.
This test requires participants to repeat back strings of digits in the reverse order in which they heard them.
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Weeks 0, 4, 8, 3-month follow- up
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Change in WAIS-IV Symbol Search
Time Frame: Weeks 0, 4, 8, 3-month follow- up
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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.
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Weeks 0, 4, 8, 3-month follow- up
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Change in DKEFS Letter and Category Naming Test
Time Frame: Weeks 0, 4, 8, 3-month follow- up
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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.
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Weeks 0, 4, 8, 3-month follow- up
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Change in California Verbal Learning Test-II
Time Frame: Weeks 0, 4, 8, 3-month follow- up
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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.
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Weeks 0, 4, 8, 3-month follow- up
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Change in Brief Visuospatial Memory Test-Revised
Time Frame: Weeks 0, 4, 8, 3-month follow- up
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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.
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Weeks 0, 4, 8, 3-month follow- up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joel R Sneed, PhD, Professor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 11, 2019
Primary Completion (Actual)
March 31, 2023
Study Completion (Actual)
March 31, 2023
Study Registration Dates
First Submitted
February 7, 2019
First Submitted That Met QC Criteria
March 8, 2019
First Posted (Actual)
March 11, 2019
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 21, 2023
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-1311
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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