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

28 aprile 2026 aggiornato da: Irma Fleming
A study looking at the safety and tolerability of KAP (Ketamine-Assisted Psychotherapy) in the burn population.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

12

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84102
        • University of Utah Health
        • Contatto:
        • Investigatore principale:
          • Irma Fleming, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Ketamine-Assisted Psychotherapy
All 12 study participants will be assigned to receive KAP treatment.
Comportamentale: Preparatory Session
A preparatory session will be completed with the subject by a trained psychotherapist to prepare them for the 1st Ketamine treatment
Droga: 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.
Droga: Ketamine-assisted Psychotherapy Session #2
The second study intervention for KAP will include a 2.5-3 hour therapy session.
Comportamentale: Integration Session
An integration session will be held with a trained psychotherapist after the 2nd Ketamine administration

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety and Tolerability defined by the number of participants with treatment-related adverse events
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility - Recruitment rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Irma Fleming

Collaboratori

University of Utah

Investigatori

  • Investigatore principale: Irma Fleming, MD, The University of Utah
  • Investigatore principale: Benjamin Lewis, MD, The University of Utah

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 aprile 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 aprile 2028

Date di iscrizione allo studio

Primo inviato

6 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 192679

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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