Computerized Cognitive Training in Young Adults With Depression

Study Overview
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Brief Summary
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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.

Official Title
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Testing the Mechanism of Action of Computerized Cognitive Training in Young Adults With Depression: Clinical, Cognitive and Neuroimaging Outcomes

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Other: Computerized Cognitive Training
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EF/PS CCT<br>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<br>* Participants will complete 8 weeks of computerized cognitive training through the Peak platform on mobile devices.<br>|
| Active Comparator: Verbal CCT<br>This group will complete verbal-focused computerized cognitive training. | Other: Computerized Cognitive Training<br>* Participants will complete 8 weeks of computerized cognitive training through the Peak platform on mobile devices.<br>|
| Placebo Comparator: Waitlist Control<br>This group will not receive cognitive training during study participation. | Other: Control<br>* This group will not receive computerized cognitive training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |