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

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

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.

Study Overview

• Status: Suspended
• Conditions: Depression
• Intervention / Treatment: Behavioral: Cognitive Training; Behavioral: Sham Training

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Western Psychiatric Institute and Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

1. Patients who do not expect to remain located in the Pittsburgh area for a minimum of 1 month beyond study enrollment.
2. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Training; 8 sessions of web-based cognitive training	Behavioral: Cognitive Training; 8 sessions of web-based cognitive training
Sham Comparator: Sham Training; 8 sessions of web-based sham training	Behavioral: Sham Training; 8 sessions of web-based sham training

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire	self-reported satisfaction with treatment; range 8-32; higher score=better rating	Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Ease of use	self-report slider scale rating; range = 0-100; high score=better rating	Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Helpfulness	self-report slider scale rating; range = 0-100; high score=better rating	Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Satisfaction with Cognitive Training	self-report slider scale rating; range = 0-100; high score=better rating	Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Future likelihood of using Cognitive Training	self-report slider scale rating; range = 0-100; high score=better rating	Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: STUDY22090145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No