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Challenges to recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Verbal CCT | Active Comparator | This group will complete verbal-focused computerized cognitive training. |
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| Waitlist Control | Placebo Comparator | This group will not receive cognitive training during study participation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Cognitive Training | Other | Participants will complete 8 weeks of computerized cognitive training through the Peak platform on mobile devices. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screen, weekly for weeks 0-8, 3-month follow-up |
| Change in WAIS-IV Coding |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 0, 4, 8, 3-month follow- up |
| Change in DKEFS Color-Word Interference Test |
Inclusion Criteria:
4. Willing and able to complete MRI, mood, and neuropsychological testing. 5. IQ > 85.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel R Sneed, PhD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queens College | New York | New York | 11367 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32743079 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 3, 2024 | |
| Reset | Oct 25, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 3, 2024 | Oct 25, 2024 |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Control | Other | This group will not receive computerized cognitive training. |
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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. |
| Weeks 0, 4, 8, 3-month follow- up |
| Change in Connectivity Index (resting state fMRI) | Measure of resting state fMRI. Higher scores indicate more connectivity within the network | Week 0, Week 4 or Week 8 (depending on randomization) |
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. |
| Weeks 0, 4, 8, 3-month follow- up |
| 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. | Weeks 0, 4, 8, 3-month follow- up |
| 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. | Weeks 0, 4, 8, 3-month follow- up |
| 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. | Weeks 0, 4, 8, 3-month follow- up |
| 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. | Weeks 0, 4, 8, 3-month follow- up |
| 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. | Weeks 0, 4, 8, 3-month follow- up |
| 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. | Weeks 0, 4, 8, 3-month follow- up |