Cognitive Training as an Adjunct to Ketamine in Real-world Clinics
NCT Number: NCT06526078
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: BEHAVIORAL: Cognitive Training|BEHAVIORAL: Sham Training
Sponsor: University of Pittsburgh
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2030-06-01
Locations: Kaiser Foundation Research Institute, a division of Kaiser Foundation Hospitals, Oakland, California, 94612, United States|University of Illinois at Chicago, Chicago, Illinois, 60612, United States|Baylor College of Medicine, Houston, Texas, 77030, United States

Summary:
In a sample of patients already receiving ketamine treatment as part of their clinical care, this project seeks to test whether we can enhance and/or extend 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.

Primary Outcome Measures: Montgomery Asberg Depression Rating Scale: During Ketamine Induction, depression severity; range 0-60; high score=worse outcome, Trajectories from baseline through end of 'induction phase' infusions (up to max of 12 weeks)|Montgomery Asberg Depression Rating Scale: After Ketamine Induction, depression severity; range 0-60; high score=worse outcome, Trajectories from final 'induction phase' infusion through 4 weeks post-induction
Secondary Outcome Measures: Quick Inventory of Depressive Symptoms, Self-reported depression (range: 0-27; higher scores = worse outcome), 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), 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, 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), Trajectories from baseline through 12 months post-induction|PROMIS Measures-anger, Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anger T-score range: 0-100 (higher score = worse outcome), 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), 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), 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), Trajectories from baseline through 12 months post-induction|Cognitive Triad Inventory, Negative perceptions of self, future, \& world (range=36-252; higher score = better outcome), 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, Trajectories from baseline through 12 months post-induction
Other Outcome Measures: Implicit Association Test, performance-based "target engagement" measure of implicit self-esteem; range = -inf-inf; high score=worse outcome, Trajectories from baseline through 4 weeks post-infusions|Columbia Suicide Severity Rating Scale--Intensity of Most Severe Ideation, suicidal ideation/thoughts; range 0-5; high score=worse outcome, Trajectories from baseline through 12 months post-induction|Patient Health Care Utilization Survey (PHCUS), interview measure of psychiatric and healthcare service utilization, Trajectories from baseline through 12 months post-induction|PROMIS Measures-substance Use, Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported substance use Raw score range: 0-35 (higher score = worse outcome), Trajectories from baseline through 12 months post-induction|PROMIS Measures-alcohol, Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported alcohol use T-score range: 0-100 (higher score = worse outcome), Trajectories from baseline through 12 months post-induction|Acceptability, Appropriateness, and Feasibility, self-report scales of intervention acceptability, appropriateness, feasibility; range = 5-20; high score=better rating, Post-CT assessment (approximately 5 days post infusion)|Short Form Health Survey, Self-report measure of Quality-Adjusted Life-Years (QALYs), Baseline through 12 months post-induction|Client Satisfaction Questionnaire (CSQ-8), Self-reported satisfaction; range: 8-32; high score=better rating, Post-CT assessment (approximately 5 days post infusion)|mHealth App Usability Questionnaire (MAUQ), Self-reported usability of cognitive training web app; range = 18-126; high score=better rating, 12 months post-induction|Qualitative interviews assessing implementation, Custom qualitative interviews with qualitative coding, 12 months post-induction|Compliance with prescribed cognitive training sessions, Compliance data from web app logs, Post-CT timepoint (approximately 5 days post infusion)|PROMIS Measures-Social Functioning, Patient-Reported Outcomes Measurement Information System (PROMIS) measures of social functioning: T-score range: 0-100 (higher score = better outcome), Trajectories from baseline through 12 months post-induction|PROMIS Measures-Pain, Patient-Reported Outcomes Measurement Information System (PROMIS) measures of pain: T-score range: 0-100 (higher score = better outcome), Trajectories from baseline through 12 months post-induction|Awe Experience Scale (AWE-S), self-report measure of awe-inspiring experiences (range: 30-210; higher score=greater awe), 24 hours post-infusion|Implicit Association Test across follow-up, performance-based "target engagement" measure of implicit self-esteem; range = -inf-inf; high score=worse outcome, Trajectories through 12 months post-induction|Time to relapse, Time-to-event for relapse to within 25% of baseline MADRS score, Baseline through 12 months post-induction|Time to first maintenance infusion, Time-to-event for the date of return to clinic for first maintenance infusion, Baseline through 12 months post-induction