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

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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

12

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Ketamine-Assisted Psychotherapy
All 12 study participants will be assigned to receive KAP treatment.
Verhalten: Preparatory Session
A preparatory session will be completed with the subject by a trained psychotherapist to prepare them for the 1st Ketamine treatment
Arzneimittel: 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.
Arzneimittel: Ketamine-assisted Psychotherapy Session #2
The second study intervention for KAP will include a 2.5-3 hour therapy session.
Verhalten: Integration Session
An integration session will be held with a trained psychotherapist after the 2nd Ketamine administration

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Safety and Tolerability defined by the number of participants with treatment-related adverse events
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility - Recruitment rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Irma Fleming

Mitarbeiter

University of Utah

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. April 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. April 2028

Studienanmeldedaten

Zuerst eingereicht

6. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. April 2026

Zuerst gepostet (Tatsächlich)

4. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 192679

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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