Testing the Mechanism of Action of Computerized Cognitive Training in Young Adults With Depression: Clinical, Cognitive and Neuroimaging Outcomes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depressive Symptoms
- Sponsor
- Queens College, The City University of New York
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change in Emotional Go/No Go Task (fMRI)
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current diagnosis of MDD/persistent depressive disorder or HDRS greater than or equal to
- •Daily access to smartphone or tablet with internet connection for the study duration.
- •Willing and able to complete MRI, mood, and neuropsychological testing.
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.
Outcomes
Primary Outcomes
Change in Emotional Go/No Go Task (fMRI)
Time Frame: Week 0, Week 4 or Week 8 (depending on randomization)
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.
Change in Sheehan Disability Scale
Time Frame: Screen, Week 0, Week 4, Week 8, 3-month follow-up
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
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.
Change in DKEFS Trail Making Test - Condition 4
Time Frame: Weeks 0, 4, 8, 3-month follow- up
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.
Secondary Outcomes
- Change in Beck Depression Inventory-II(Screen, weekly for weeks 0-8, 3-month follow-up)
- Change in WAIS-IV Coding(Weeks 0, 4, 8, 3-month follow- up)
- Change in Connectivity Index (resting state fMRI)(Week 0, Week 4 or Week 8 (depending on randomization))