Back to resultsComputerized Cognitive Training in Young Adults With Depression
Primary Purpose
Depressive Symptoms
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Cognitive Training
Control
Sponsored by
About this trial
This is an interventional other trial for Depressive Symptoms
Eligibility Criteria
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.
Sites / Locations
- Queens College
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
EF/PS CCT
Verbal CCT
Waitlist Control
Arm Description
This group will complete EF/PS (executive functioning/processing speed) computerized cognitive training (CCT) which includes games specifically focused on executive function & processing speed.
This group will complete verbal-focused computerized cognitive training.
This group will not receive cognitive training during study participation.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Change in Connectivity Index (resting state fMRI)
Measure of resting state fMRI. Higher scores indicate more connectivity within the network
Full Information
NCT ID
NCT03869463
First Posted
February 7, 2019
Last Updated
September 21, 2023
Sponsor
Queens College, The City University of New York
1. Study Identification
Unique Protocol Identification Number
NCT03869463
Brief Title
Computerized Cognitive Training in Young Adults With Depression
Official Title
Testing the Mechanism of Action of Computerized Cognitive Training in Young Adults With Depression: Clinical, Cognitive and Neuroimaging Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Challenges to recruitment
Study Start Date
October 11, 2019 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queens College, The City University of New York
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EF/PS CCT
Arm Type
Experimental
Arm Description
This group will complete EF/PS (executive functioning/processing speed) computerized cognitive training (CCT) which includes games specifically focused on executive function & processing speed.
Arm Title
Verbal CCT
Arm Type
Active Comparator
Arm Description
This group will complete verbal-focused computerized cognitive training.
Arm Title
Waitlist Control
Arm Type
Placebo Comparator
Arm Description
This group will not receive cognitive training during study participation.
Intervention Type
Other
Intervention Name(s)
Computerized Cognitive Training
Intervention Description
Participants will complete 8 weeks of computerized cognitive training through the Peak platform on mobile devices.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
This group will not receive computerized cognitive training.
Primary Outcome Measure Information:
Title
Change in Sheehan Disability Scale
Description
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
Title
Change in Hamilton Depression Rating Scale
Description
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
Title
Change in DKEFS Trail Making Test - Condition 4
Description
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
Title
Change in Emotional Go/No Go Task (fMRI)
Description
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 Outcome Measure Information:
Title
Change in Beck Depression Inventory-II
Description
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
Title
Change in WAIS-IV Coding
Description
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
Title
Change in Connectivity Index (resting state fMRI)
Description
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 Pre-specified Outcome Measures:
Title
Change in DKEFS Trail Making Test - Condition 2
Description
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
Title
Change in DKEFS Color-Word Interference Test
Description
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
Title
Change in WAIS-IV Digit Span Forwards
Description
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
Title
Change in WAIS-IV Digit Span Backwards
Description
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
Title
Change in WAIS-IV Symbol Search
Description
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
Title
Change in DKEFS Letter and Category Naming Test
Description
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
Title
Change in California Verbal Learning Test-II
Description
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
Title
Change in Brief Visuospatial Memory Test-Revised
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel R Sneed, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queens College
City
New York
State/Province
New York
ZIP/Postal Code
11367
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32743079
Citation
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.
Results Reference
derived
Learn more about this trial
Computerized Cognitive Training in Young Adults With Depression
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