Testing the Effectiveness of Cognitive Training Among Depressed Patients Receiving Esketamine Treatment

Study Overview
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Brief Summary
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In a sample of patients already receiving esketamine treatment as part of their clinical care, this project seeks to test whether we can improve depression by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat depression more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.

Official Title
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Cognitive Training to Enhance Depression Relief: Testing an Adjunct to Clinical Esketamine Treatment

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Cognitive Training
* Behavioral: Sham Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient aged 18-80 in the esketamine clinic in the Center for Interventional Psychiatry. The clinic's extensive screening and eligibility criteria for esketamine treatment will not be altered in any way, other than imposing the study-specific age range and the two exclusion criteria below. Exclusion Criteria: Patients who do not expect to remain located in the Pittsburgh area for a minimum of 1 month beyond study enrollment. Patients who, in the judgment of the esketamine clinical medical director, show signs of intellectual disability, developmental disability, and/or cognitive impairment (including age-related cognitive decline) of a sufficient degree to interfere with engagement in any study procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Training<br>8 sessions of web-based cognitive training | Behavioral: Cognitive Training<br>* 8 sessions of web-based cognitive training<br>|
| Sham Comparator: Sham Training<br>8 sessions of web-based sham training | Behavioral: Sham Training<br>* 8 sessions of web-based sham training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | Trajectories from baseline through 1 month | 
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | Trajectories from baseline through 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale modified score | Clinician-rated depression (range: 0-52; higher scores = worse outcome) | Trajectories from baseline through 1 month | 
| Clinical Global Impression Scale--Improvement | range 1-7 (higher score=worse outcome) | Trajectories from baseline through 1 month | 
| Clinical Global Impression Scale--Severity | range 1-7 (higher score=worse outcome) | Trajectories from baseline through 1 month | 
| Frequency of scheduled esketamine visits | The frequency of scheduled esketamine visits, optimized according to clinicians' judgment of response and patient preferences | During first month | 
| Number of patients terminated from esketamine therapy | Number with esketamine treatment terminated by the clinic's embedded providers due to lack of clinical response after 1-month of treatment | During first 6 months |