Clinical trial NCT03869463: 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
Overall status: TERMINATED
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: Queens College, The City University of New York
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

4. 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.

Primary outcomes:
measure: Change in Sheehan Disability Scale
timeFrame: Screen, Week 0, Week 4, Week 8, 3-month follow-up
measure: Change in Hamilton Depression Rating Scale
timeFrame: Screen, Week 0, Week 4, Week 8, 3-month follow-up
measure: Change in DKEFS Trail Making Test - Condition 4
timeFrame: Weeks 0, 4, 8, 3-month follow- up
measure: Change in Emotional Go/No Go Task (fMRI)
timeFrame: Week 0, Week 4 or Week 8 (depending on randomization)
Secondary outcomes:
measure: Change in Beck Depression Inventory-II
timeFrame: Screen, weekly for weeks 0-8, 3-month follow-up
measure: Change in WAIS-IV Coding
timeFrame: Weeks 0, 4, 8, 3-month follow- up
measure: Change in Connectivity Index (resting state fMRI)
timeFrame: Week 0, Week 4 or Week 8 (depending on randomization)
Other outcomes:
measure: Change in DKEFS Trail Making Test - Condition 2
timeFrame: Weeks 0, 4, 8, 3-month follow- up
measure: Change in DKEFS Color-Word Interference Test
timeFrame: Weeks 0, 4, 8, 3-month follow- up
measure: Change in WAIS-IV Digit Span Forwards
timeFrame: Weeks 0, 4, 8, 3-month follow- up
measure: Change in WAIS-IV Digit Span Backwards
timeFrame: Weeks 0, 4, 8, 3-month follow- up
measure: Change in WAIS-IV Symbol Search
timeFrame: Weeks 0, 4, 8, 3-month follow- up
measure: Change in DKEFS Letter and Category Naming Test
timeFrame: Weeks 0, 4, 8, 3-month follow- up
measure: Change in California Verbal Learning Test-II
timeFrame: Weeks 0, 4, 8, 3-month follow- up
measure: Change in Brief Visuospatial Memory Test-Revised
timeFrame: Weeks 0, 4, 8, 3-month follow- up
Locations:
city: New York
country: United States
facility: Queens College
state: New York
Study officials:
affiliation: Professor
name: Joel R Sneed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.