Clinical trial NCT05719909: Testing the Effectiveness of Cognitive Training Among Depressed Patients Receiving Esketamine Treatment
Official title: Cognitive Training to Enhance Depression Relief: Testing an Adjunct to Clinical Esketamine Treatment
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Depression
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale
timeFrame: Trajectories from baseline through 1 month
measure: Quick Inventory of Depressive Symptoms
timeFrame: Trajectories from baseline through 1 month
Secondary outcomes:
measure: Hamilton Depression Rating Scale modified score
timeFrame: Trajectories from baseline through 1 month
measure: Clinical Global Impression Scale--Improvement
timeFrame: Trajectories from baseline through 1 month
measure: Clinical Global Impression Scale--Severity
timeFrame: Trajectories from baseline through 1 month
measure: Frequency of scheduled esketamine visits
timeFrame: During first month
measure: Number of patients terminated from esketamine therapy
timeFrame: During first 6 months
Other outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
measure: Ease of use
timeFrame: Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
measure: Helpfulness
timeFrame: Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
measure: Satisfaction with Cognitive Training
timeFrame: Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
measure: Future likelihood of using Cognitive Training
timeFrame: Assessment at 'post-CT' timepoint (completed approximately 1 week following randomization)
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
References: