Cognitive Training as an Adjunct to Ketamine in Real-world Clinics
- Conditions
- Depression
- Interventions
- Behavioral: Cognitive TrainingBehavioral: Sham Training
- Registration Number
- NCT06526078
- Lead Sponsor
- University of Pittsburgh
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 600
- be between the ages of 18 and 80 years
- score ≥20 on the Montgomery-Asberg Depression Rating Scale (MADRS)
- per SCID-5-RV interview, meet DSM-5 diagnostic criteria for at least one of the following: Major Depressive Disorder, Bipolar Disorder (I or II), Persistent Depressive Disorder, or Other Specified Depressive or Bipolar Disorder
- exhibit treatment resistance, defined as: (a) failure to respond to ≥1 adequate trials of an evidence-based treatment for mood disorder [per the Antidepressant Treatment History Form-Short Form Modified Score Sheet (ATHF-SF-Modified)] and/or (b) failure to respond to ≥1 adequate mood stabilizer or other evidence-based treatment trials (for bipolar depression patients) and/or (c) a history of intolerance during attempted trials of evidence-based treatments for mood disorders
- be eligible and clinically enrolled for upcoming IV ketamine at one of our study clinics according to that clinic's standard intake procedures
- agree to maintain a stable schedule of concomitant psychiatric medications throughout the ketamine induction phase (minor adjustments to PRN meds and timing of meds are allowable), and for 4 weeks post-induction phase
- possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document
- be willing and able to provide names and contact information for at least 1 additional emergency contact in the patient's proximal geographic area (in addition to the ketamine treatment team at the enrolling site)
- Presence of current/acute psychosis, mania, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment (e.g., autism spectrum disorder)
- Current/acute suicide risk with intent to act, defined as CSSRS past-week ideation score ≥ 4 among outpatients; patients engaged in residential or inpatient care at the time of enrollment need not meet this CSSRS score criterion, as their current/acute suicide risk is extremely low by virtue of the residential/inpatient, round-the-clock care they are already receiving at time of enrollment
- Concern for dementia or significant cognitive decline, per interviewer observations and impressions during screening assessments
- Current pregnancy or breastfeeding
- English reading level <5th grade as per patient self-report Rationale: to ensure adequate reading comprehension for verbal ASAT/sham stimuli which are presented in English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Training Cognitive Training Web-based cognitive training Sham Training Sham Training Web-based sham training
- Primary Outcome Measures
Name Time Method Montgomery Asberg Depression Rating Scale: During Ketamine Induction Trajectories from baseline through end of 'induction phase' infusions (up to max of 12 weeks) depression severity; range 0-60; high score=worse outcome
Montgomery Asberg Depression Rating Scale: After Ketamine Induction Trajectories from final 'induction phase' infusion through 4 weeks post-induction depression severity; range 0-60; high score=worse outcome
- Secondary Outcome Measures
Name Time Method Quick Inventory of Depressive Symptoms Trajectories from baseline through 12 months post-induction Self-reported depression (range: 0-27; higher scores = worse outcome)
Beck Hopelessness Scale Trajectories from baseline through 12 months post-induction self reported to measure key aspects of hopelessness; range = 0-20, higher score=worse outcome
PROMIS Measures-Positive Affect Trajectories from baseline through 12 months post-induction Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported positive affect/well-being T-score range: 0-100 (higher score = better outcome)
PROMIS Measures-Cognitive Function Trajectories from baseline through 12 months post-induction Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported cognitive function T-score range: 0-100 (higher score = better outcome)
Cognitive Triad Inventory Trajectories from baseline through 12 months post-induction Negative perceptions of self, future, \& world (range=36-252; higher score = better outcome)
PROMIS Measures-depression Trajectories from baseline through 12 months post-induction Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported depression T-score range: 0-100 (higher score = worse outcome)
PROMIS Measures-anger Trajectories from baseline through 12 months post-induction Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anger T-score range: 0-100 (higher score = worse outcome)
PROMIS Measures-anxiety Trajectories from baseline through 12 months post-induction Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported anxiety T-score range: 0-100 (higher score = worse outcome)
PROMIS Measures-Sleep Disturbance Trajectories from baseline through 12 months post-induction Patient-Reported Outcomes Measurement Information System (PROMIS) measure: Self-reported sleep disturbance T-score range: 0-100 (higher score = worse outcome)
Montgomery Asberg Depression Rating Scale: Naturalistic Follow-up Trajectories from baseline through 12 months post-induction depression severity; range 0-60; high score=worse outcome
Trial Locations
- Locations (3)
Kaiser Foundation Research Institute, a division of Kaiser Foundation Hospitals
🇺🇸Oakland, California, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States