KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury (KALM-B)

April 28, 2026 updated by: Irma Fleming
A study looking at the safety and tolerability of KAP (Ketamine-Assisted Psychotherapy) in the burn population.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND AND RATIONALE Burn injuries are among the most devastating forms of trauma, often resulting in significant physical pain and long-term psychological distress. Survivors frequently experience acute stress disorder (ASD), which may progress to post-traumatic stress disorder (PTSD), depression, anxiety, and chronic opioid dependence. PTSD has been documented in up to 45% of military burn survivors and approximately one-third of civilians with severe burn trauma. Despite improvements in surgical and rehabilitative care, the psychological sequelae of burn injuries remain under-recognized and under-treated.

The immediate post-injury period is marked by elevated stress and emotional dysregulation, yet access to timely, structured mental health interventions is limited. Traditional approaches often fail to reach patients during this critical window. At the University of Utah Burn Center, which treats over 450 inpatients and 6,500 outpatients annually, there is an urgent need for feasible and scalable approaches to address psychological distress early in the recovery process.

Ketamine-assisted psychotherapy (KAP) combines the administration of ketamine, a dissociative anesthetic with well-documented rapid-onset antidepressant properties, with psychotherapeutic support in a controlled clinical environment. KAP has shown potential in other trauma-affected populations and is being explored for its ability to support emotional processing, reduce distress, and potentially interrupt the progression from acute stress to more persistent mental health disorders. However, its use in the context of acute burn injury has not been systematically evaluated.

The KALM-B Study (Ketamine-Assisted Therapy to Lessen Morbidity after Burn Injury) is a pilot project designed to assess the safety and feasibility of implementing KAP in recently burned patients with acute stress symptoms. The study will recruit 12 adult patients who screen positive for acute stress symptoms during their hospitalization and offer participation in up to two KAP sessions following discharge, delivered in partnership with the Huntsman Mental Health Institute.

The primary objective is to evaluate the safety and tolerability of KAP after burn and the feasibility of recruitment, enrollment, and completion of the study intervention. Secondary objectives include assessing the safety and tolerability of KAP in this unique patient population. Exploratory objectives will descriptively assess changes in symptoms of acute stress, anxiety, depression, and opioid use through 6 months post-intervention.

This study represents a first step toward understanding how novel trauma-informed interventions might be integrated into early burn care. By characterizing feasibility, safety, and symptom trends over time, KALM-B will provide foundational data to inform future research and potential care models aimed at supporting psychological recovery after burn injury.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • University of Utah Health
        • Contact:
        • Principal Investigator:
          • Irma Fleming, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects 18 - 65 yrs with > 15 % Total Body Surface Area Burns.
  • National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS) average total score>= 2 (severity scale of none (0), mild (1), moderate (2), severe (3), or extreme (4) ) prior to discharge from UUH.

Exclusion Criteria:

  • Allergy or previous adverse reactions to ketamine
  • Pending surgical interventions
  • Active systemic infection, sepsis, or hemodynamic instability
  • Physical limitations from burn injury that preclude safe travel to outpatient visits or positioning for therapy.
  • Lack of reliable transportation, caregiver support, or housing stability.
  • Language barrier
  • Personal history or first- or second-degree relatives with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder, psychosis, or other psychotic spectrum illness.
  • Currently meeting DSM-5 criteria for Dissociative Disorder, or other psychiatric conditions judged to be incompatible with the establishment of rapport or safe exposure to ketamine.
  • Currently meeting DSM-5 criteria for Cluster B Personality Disorder.
  • Severe depression requiring immediate standard-of-care treatment (e.g., hospitalization).
  • Suicidal ideation over the past month as assessed as a yes to question 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale, Suicidal Ideation section
  • Current or prior history of PTSD diagnosis
  • Current or history within the last two years of meeting DSM-V criteria of substance use disorder (excluding caffeine and nicotine).
  • Current substance use disorders may be identified through the drug urine screening test or undergoing treatment (methadone/Suboxone) .
  • Congestive heart failure, including all New York Heart Association Classes.
  • Angina pectoris, cardiac hypertrophy, cardiac ischemia, myocardial infarction
  • Uncontrolled hypertension at the time of enrollment (BP>140 systolic or 90 diastolic), coronary artery disease, artificial heart valve
  • Prolonged or congenital long QT syndrome (>450 ms), serious cardiac arrhythmias, tachycardia, a clinically significant screening ECG abnormality
  • History of hypersensitivity to ketamine
  • Receiving ketamine treatments for psychiatric condition within the past 6 months
  • Seizure disorder
  • Moderate to severe dementia
  • History of significant traumatic brain injury
  • Requires the use of supplemental oxygen.
  • Require Propranolol for Burn Hypermetabolism
  • Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [patients may not receive the drug through a feeding tube], social/ psychological issues, etc.)
  • Subjects taking prohibited medications. A washout period of prohibited medications for a period of at least five half-lives should occur prior to study registration. These medications include antipsychotic medications, doses of benzodiazepines in excess of 20mg diazepam equivalents per day.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine-Assisted Psychotherapy
All 12 study participants will be assigned to receive KAP treatment.
Behavioral: Preparatory Session
A preparatory session will be completed with the subject by a trained psychotherapist to prepare them for the 1st Ketamine treatment
Drug: Ketamine-assisted Psychotherapy Session #1
Ketamine will be administered intra-muscularly at a starting dose of 0.5 mg/kg and can be titrated up to 1.0 mg/kg, to a maximum of 60 mg, based on patient response. The first study intervention for KAP will include a preparatory session a 2.5-3 hour therapy session.
Drug: Ketamine-assisted Psychotherapy Session #2
The second study intervention for KAP will include a 2.5-3 hour therapy session.
Behavioral: Integration Session
An integration session will be held with a trained psychotherapist after the 2nd Ketamine administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability defined by the number of participants with treatment-related adverse events
Time Frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Assess the safety and tolerability of KAP in the burn population. Safety and Tolerability will be measure by the frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.
From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - Recruitment rate
Time Frame: From study opening to completion of recruitment, up to 24 months
The proportion of eligible participants who provided informed consent
From study opening to completion of recruitment, up to 24 months
Feasibility - Treatment Completion Rate
Time Frame: From enrollment through completion of all scheduled KAP sessions, assessed up to 12 weeks
Proportion of participants who complete all scheduled KAP sessions.
From enrollment through completion of all scheduled KAP sessions, assessed up to 12 weeks
Feasibility - Follow-up Completion Rate
Time Frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Proportion of participants who complete follow-up assessments at 1, 3, and 6 months.
From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Timeliness of Intervention Delivery
Time Frame: Baseline (from injury to initiation of treatment; up to 12 months)
Time from injury to initiation of the KAP intervention, defined as the number of days between the date of injury and the date of first KAP session.
Baseline (from injury to initiation of treatment; up to 12 months)
Opioid Use
Time Frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Total opioid use (MME) at discharge and up to 6 months post-KAP.
From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Acute Stress Symptoms based on National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS)
Time Frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)

Change in acute stress symptoms from baseline to post-treatment follow-up, measured using the National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS).

Scoring and Interpretation: Each item is rated on a 5-point scale (0=Not at all; 1=A little bit; 2=Moderately; 3=Quite a bit, and 4=Extremely). The total score can range from 0 to 28, with higher scores indicating greater severity of acute stress disorder.

The raw scores on the 7 items should be summed to obtain a total raw score. In addition, the clinician is asked to calculate and use the average total score. The average total score reduces the overall score to a 5-point scale, which allows the clinician to think of the severity of the individual's acute stress disorder in terms of none (0), mild (1), moderate (2), severe (3), or extreme (4).
From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Incidence of PTSD based on PTSD Checklist for DSM-5 (PCL-5)
Time Frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)

Incidence of progression from acute stress to PTSD at follow-up, based on DSM-5 criteria and assessed using the PTSD Checklist for DSM-5 (PCL-5). The PCL-5 can be scored to provide a provisional PTSD diagnosis.

Scoring and Interpretation: The PCL-5 is a 20-item self-report questionnaire assessing DSM-5 PTSD symptoms, scored from 0-80 by summing items rated 0 ("Not at all") to 4 ("Extremely"). A total score of 31-33 or higher typically indicates a probable PTSD diagnosis, though 32 is often used. A 5-point change represents a clinically significant change.
From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Anxiety Symptoms based on the Generalized Anxiety Disorder 7-item scale
Time Frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)

Change in anxiety symptoms from baseline to follow-up, measured using the Generalized Anxiety Disorder 7-item scale (GAD-7).

Scoring and Interpretation: The GAD-7 (Generalized Anxiety Disorder-7) is a 7-item, self-report scale used to measure anxiety severity, with a total score range of 0-21. Scores are calculated by summing the ratings (0-3) for seven questions, with cut-offs of 5, 10, and 15 representing:

0-4: Minimal or no anxiety 5-9: Mild anxiety (monitor; consider lifestyle changes) 10-14: Moderate anxiety (clinically significant; consider counseling/medication) 15-21: Severe anxiety (refer to a mental health professional) Cut-off for Diagnosis: A score of 10 or higher is generally used to identify potential Generalized Anxiety Disorder.
From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
Depressive Symptoms based on Patient Health Questionnaire-9 Screening tool
Time Frame: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)

Change in depressive symptoms from baseline to follow-up, measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is scored by summing 9 items (0-3 each) to a total of 0-27, with higher scores indicating severe depression.

Interpretation of Total Score:

0-4: Minimal or None 5-9: Mild depression (suggests monitoring) 10-14: Moderate depression (suggests treatment) 15-19: Moderately severe depression (often requires active treatment) 20-27: Severe depression (usually requires immediate intervention)
From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Irma Fleming

Collaborators

University of Utah

Investigators

  • Principal Investigator: Irma Fleming, MD, The University of Utah
  • Principal Investigator: Benjamin Lewis, MD, The University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192679

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. This investigator-initiated feasibility study is not funded by an agency that requires data sharing, and the small sample size combined with the sensitive nature of the data limits the ability to adequately de-identify individual participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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