In a sample of patients already receiving ketamine (or esketamine) treatment as part of their clinical care, this project seeks to test whether we can enhance and/or extend (es)ketamine's rapid effects by introducing helpful information delivered by a computer-based cognitive 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
Sessions of cognitive training exercises (15-20min each) self-administered via a web app
Sessions of sham training exercises (15-20min each) self-administered via a web app
Kaiser Foundation Research Institute, a division of Kaiser Foundation Hospitals
Oakland, California, United States
NOT_YET_RECRUITINGUniversity of Illinois at Chicago
Chicago, Illinois, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGMontgomery Asberg Depression Rating Scale: During (Es)Ketamine Induction
depression severity; range 0-60; high score=worse outcome
Time frame: Trajectories from baseline through end of 'induction phase' treatments (up to max of 12 weeks)
Montgomery Asberg Depression Rating Scale: After (Es)Ketamine Induction
depression severity; range 0-60; high score=worse outcome
Time frame: Trajectories from final 'induction phase' treatment through 4 weeks post-induction
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: Trajectories from baseline through 12 months post-induction
PROMIS Measures-depression
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported depression T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from baseline through 12 months post-induction
Beck Hopelessness Scale
self reported to measure key aspects of hopelessness; range = 0-20, higher score=worse outcome
Time frame: Trajectories from baseline through 12 months post-induction
PROMIS Measures-anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anxiety T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from baseline through 12 months post-induction
PROMIS Measures-anger
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Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anger T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from baseline through 12 months post-induction
PROMIS Measures-Positive Affect
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported positive affect/well-being T-score range: 0-100 (higher score = better outcome)
Time frame: Trajectories from baseline through 12 months post-induction
PROMIS Measures-Sleep Disturbance
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported sleep disturbance T-score range: 0-100 (higher score = worse outcome)
Time frame: Trajectories from baseline through 12 months post-induction
PROMIS Measures-Cognitive Function
Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported cognitive function T-score range: 0-100 (higher score = better outcome)
Time frame: Trajectories from baseline through 12 months post-induction
Cognitive Triad Inventory
Negative perceptions of self, future, \& world (range=36-252; higher score = better outcome)
Time frame: Trajectories from baseline through 12 months post-induction
Montgomery Asberg Depression Rating Scale: Naturalistic Follow-up
depression severity; range 0-60; high score=worse outcome
Time frame: Trajectories from baseline through 12 months post-induction