Computerized Cognitive Training in Young Adults With Depression

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03869463
• Other study ID #: 2018-1311
• Status: Terminated
• Phase: N/A
• Start date: October 11, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2022
• Source: Queens College, The City University of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Other:
• Computerized Cognitive Training
Participants will complete 8 weeks of computerized cognitive training through the Peak platform on mobile devices.
• Control
This group will not receive computerized cognitive training.

Locations

Country	Name	City	State
United States	Queens College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Queens College, The City University of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in DKEFS Color-Word Interference Test	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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)