Testing the Mechanism of Action of Computerized Cognitive Training in Young Adults with Depression: Protocol for a Blinded, Randomized, Controlled Treatment Trial

Sara N Rushia, Sophie Schiff, Dakota A Egglefield, Jeffrey N Motter, Alice Grinberg, Daniel G Saldana, Al Amira Safa Shehab, Jin Fan, Joel R Sneed, Sara N Rushia, Sophie Schiff, Dakota A Egglefield, Jeffrey N Motter, Alice Grinberg, Daniel G Saldana, Al Amira Safa Shehab, Jin Fan, Joel R Sneed

Abstract

Background: Depression is associated with a broad range of cognitive deficits, including processing speed (PS) and executive functioning (EF). Cognitive symptoms commonly persist with the resolution of affective symptoms and increase risk of relapse and recurrence. The cognitive control network is comprised of brain areas implicated in EF and mood regulatory functions. Prior research has demonstrated the effectiveness of computerized cognitive training (CCT) focused on PS and EF in mitigating both cognitive and affective symptoms of depression.

Methods: Ninety participants aged 18-29 with a current diagnosis of major depressive disorder or persistent depressive disorder, or a Hamilton Depression Rating Scale score ≥12, will be randomized to either PS/EF CCT, verbal CCT, or waitlist control. Participants in the active groups will complete 15 min of training 5 days/week for 8 weeks. Clinical and neuropsychological assessments will be completed at baseline, week 4, week 8, and 3-month follow-up. Structural and functional magnetic resonance imaging (fMRI) will be completed at baseline and week 8. We will compare changes in mood, cognition, daily functioning, and fMRI data. We will explore cognitive control network functioning using resting-state and task-based fMRI.

Results: Recruitment began in October 2019; we expect to finish recruitment by April 2022 and subsequently begin data analysis.

Conclusions: This study is innovative in that it will include both active and waitlist control conditions and will explore changes in neural activation. Identifying the neural networks associated with improvements following CCT will allow for the development of more precise and effective interventions.

Trial registration: ClinicalTrials.gov NCT03869463; https://ichgcp.net/clinical-trials-registry/NCT03869463.

Keywords: clinical trials; computerized cognitive training; depression; magnetic resonance imaging.

Conflict of interest statement

CONFLICTS OF INTEREST SNR, SS, DAE, JNM, AG, DGS, AS, JF, and JRS have no conflicts of interest.

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