KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury (KALM-B)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Claire Ausbeck, BA
- Número de teléfono: 18014033671
- Correo electrónico: claire.ausbeck@hsc.utah.edu
Ubicaciones de estudio
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Utah
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Salt Lake City, Utah, Estados Unidos, 84102
- University of Utah Health
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Contacto:
- Claire Ausbeck, BA
- Número de teléfono: 801-213-1223
- Correo electrónico: claire.ausbeck@hsc.utah.edu
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Investigador principal:
- Irma Fleming, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Ketamine-Assisted Psychotherapy
All 12 study participants will be assigned to receive KAP treatment.
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A preparatory session will be completed with the subject by a trained psychotherapist to prepare them for the 1st Ketamine treatment
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.
The second study intervention for KAP will include a 2.5-3 hour therapy session.
An integration session will be held with a trained psychotherapist after the 2nd Ketamine administration
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Safety and Tolerability defined by the number of participants with treatment-related adverse events
Periodo de tiempo: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
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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.
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From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Feasibility - Recruitment rate
Periodo de tiempo: From study opening to completion of recruitment, up to 24 months
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The proportion of eligible participants who provided informed consent
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From study opening to completion of recruitment, up to 24 months
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Feasibility - Treatment Completion Rate
Periodo de tiempo: From enrollment through completion of all scheduled KAP sessions, assessed up to 12 weeks
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Proportion of participants who complete all scheduled KAP sessions.
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From enrollment through completion of all scheduled KAP sessions, assessed up to 12 weeks
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Feasibility - Follow-up Completion Rate
Periodo de tiempo: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
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Proportion of participants who complete follow-up assessments at 1, 3, and 6 months.
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From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
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Timeliness of Intervention Delivery
Periodo de tiempo: Baseline (from injury to initiation of treatment; up to 12 months)
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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.
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Baseline (from injury to initiation of treatment; up to 12 months)
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Opioid Use
Periodo de tiempo: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
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Total opioid use (MME) at discharge and up to 6 months post-KAP.
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From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
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Acute Stress Symptoms based on National Stressful Events Survey Acute Stress Disorder Short Scale (NSESSS)
Periodo de tiempo: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
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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)
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Incidence of PTSD based on PTSD Checklist for DSM-5 (PCL-5)
Periodo de tiempo: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
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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)
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Anxiety Symptoms based on the Generalized Anxiety Disorder 7-item scale
Periodo de tiempo: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
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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)
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Depressive Symptoms based on Patient Health Questionnaire-9 Screening tool
Periodo de tiempo: From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months)
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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)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Irma Fleming, MD, The University of Utah
- Investigador principal: Benjamin Lewis, MD, The University of Utah
Publicaciones y enlaces útiles
Publicaciones Generales
- Singh JB, Fedgchin M, Daly EJ, De Boer P, Cooper K, Lim P, Pinter C, Murrough JW, Sanacora G, Shelton RC, Kurian B, Winokur A, Fava M, Manji H, Drevets WC, Van Nueten L. A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression. Am J Psychiatry. 2016 Aug 1;173(8):816-26. doi: 10.1176/appi.ajp.2016.16010037. Epub 2016 Apr 8.
- Feder A, Parides MK, Murrough JW, Perez AM, Morgan JE, Saxena S, Kirkwood K, Aan Het Rot M, Lapidus KA, Wan LB, Iosifescu D, Charney DS. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):681-8. doi: 10.1001/jamapsychiatry.2014.62.
- Fava M, Freeman MP, Flynn M, Judge H, Hoeppner BB, Cusin C, Ionescu DF, Mathew SJ, Chang LC, Iosifescu DV, Murrough J, Debattista C, Schatzberg AF, Trivedi MH, Jha MK, Sanacora G, Wilkinson ST, Papakostas GI. Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD). Mol Psychiatry. 2020 Jul;25(7):1592-1603. doi: 10.1038/s41380-018-0256-5. Epub 2018 Oct 3.
- Castellanos JP, Woolley C, Bruno KA, Zeidan F, Halberstadt A, Furnish T. Chronic pain and psychedelics: a review and proposed mechanism of action. Reg Anesth Pain Med. 2020 Jul;45(7):486-494. doi: 10.1136/rapm-2020-101273. Epub 2020 May 4.
- Le Cornec C, Le Pottier M, Broch H, Marguinaud Tixier A, Rousseau E, Laribi S, Janiere C, Brenckmann V, Guillerm A, Deciron F, Kabbaj A, Jenvrin J, Pere M, Montassier E. Ketamine Compared With Morphine for Out-of-Hospital Analgesia for Patients With Traumatic Pain: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352844. doi: 10.1001/jamanetworkopen.2023.52844.
- Du R, Han R, Niu K, Xu J, Zhao Z, Lu G, Shang Y. The Multivariate Effect of Ketamine on PTSD: Systematic Review and Meta-Analysis. Front Psychiatry. 2022 Mar 9;13:813103. doi: 10.3389/fpsyt.2022.813103. eCollection 2022.
- Fremont R, Brown O, Feder A, Murrough J. Ketamine for Treatment of Posttraumatic Stress Disorder: State of the Field. Focus (Am Psychiatr Publ). 2023 Jul;21(3):257-265. doi: 10.1176/appi.focus.20230006. Epub 2023 Jun 28.
- Romanowski KS, Carson J, Pape K, Bernal E, Sharar S, Wiechman S, Carter D, Liu YM, Nitzschke S, Bhalla P, Litt J, Przkora R, Friedman B, Popiak S, Jeng J, Ryan CM, Joe V. American Burn Association Guidelines on the Management of Acute Pain in the Adult Burn Patient: A Review of the Literature, a Compilation of Expert Opinion, and Next Steps. J Burn Care Res. 2020 Nov 30;41(6):1129-1151. doi: 10.1093/jbcr/iraa119.
- Stojanovic M, Marinkovic M, Milicic B, Stojicic M, Jovic M, Jovanovic M, Isakovic Subotic J, Jurisic M, Karamarkovic M, Dekic A, Radenovic K, Mihaljevic J, Radosavljevic I, Sudecki B, Savic M, Kostic M, Garabinovic Z, Jeremic J. The Role of Ketamine as a Component of Multimodal Analgesia in Burns: A Retrospective Observational Study. J Clin Med. 2024 Jan 29;13(3):764. doi: 10.3390/jcm13030764.
- Lewis BR, Garland EL, Byrne K, Durns T, Hendrick J, Beck A, Thielking P. HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. J Pain Symptom Manage. 2023 Sep;66(3):258-269. doi: 10.1016/j.jpainsymman.2023.06.006. Epub 2023 Jun 10.
- Dakwar E, Levin F, Hart CL, Basaraba C, Choi J, Pavlicova M, Nunes EV. A Single Ketamine Infusion Combined With Motivational Enhancement Therapy for Alcohol Use Disorder: A Randomized Midazolam-Controlled Pilot Trial. Am J Psychiatry. 2020 Feb 1;177(2):125-133. doi: 10.1176/appi.ajp.2019.19070684. Epub 2019 Dec 2.
- Dore J, Turnipseed B, Dwyer S, Turnipseed A, Andries J, Ascani G, Monnette C, Huidekoper A, Strauss N, Wolfson P. Ketamine Assisted Psychotherapy (KAP): Patient Demographics, Clinical Data and Outcomes in Three Large Practices Administering Ketamine with Psychotherapy. J Psychoactive Drugs. 2019 Apr-Jun;51(2):189-198. doi: 10.1080/02791072.2019.1587556. Epub 2019 Mar 27.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 192679
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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