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

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05719909
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Cognitive Training; Behavioral: Sham Training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Cognitive Training to Enhance Depression Relief: Testing an Adjunct to Clinical Esketamine Treatment
• Anticipated Study Start Date: Feb 28, 2023
• Anticipated Primary Completion Date: Feb 28, 2025
• Anticipated Study Completion Date: Aug 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Montgomery Asberg Depression Rating Scale [Trajectories from baseline through 1 month]

   depression severity; range 0-60; high score=worse outcome

2. Quick Inventory of Depressive Symptoms [Trajectories from baseline through 1 month]

   Self-reported depression (range: 0-27; higher scores = worse outcome)

Secondary Outcome Measures

1. Hamilton Depression Rating Scale modified score [Trajectories from baseline through 1 month]

   Clinician-rated depression (range: 0-52; higher scores = worse outcome)

2. Clinical Global Impression Scale--Improvement [Trajectories from baseline through 1 month]

   range 1-7 (higher score=worse outcome)

3. Clinical Global Impression Scale--Severity [Trajectories from baseline through 1 month]

   range 1-7 (higher score=worse outcome)

4. Frequency of scheduled esketamine visits [During first month]

   The frequency of scheduled esketamine visits, optimized according to clinicians' judgment of response and patient preferences

5. Number of patients terminated from esketamine therapy [During first 6 months]

   Number with esketamine treatment terminated by the clinic's embedded providers due to lack of clinical response after 1-month of treatment

Other Outcome Measures

1. Client Satisfaction Questionnaire [Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)]

   self-reported satisfaction with treatment; range 8-32; higher score=better rating

2. Ease of use [Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)]

   self-report slider scale rating; range = 0-100; high score=better rating

3. Helpfulness [Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)]

   self-report slider scale rating; range = 0-100; high score=better rating

4. Satisfaction with Cognitive Training [Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)]

   self-report slider scale rating; range = 0-100; high score=better rating

5. Future likelihood of using Cognitive Training [Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)]

   self-report slider scale rating; range = 0-100; high score=better rating

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rebecca Price, Associate Professor of Psychiatry and Psychology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT05719909
• Other Study ID Numbers: STUDY22090145
• First Posted: Feb 9, 2023
• Last Update Posted: Feb 15, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of Feb 15, 2023