此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年8月25日 更新者：Irma Fleming
A study looking at the safety and tolerability of KAP (Ketamine-Assisted Psychotherapy) in the burn population.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

12

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Utah
      • Salt Lake City、Utah、美国、84102
        • 招聘中
        • University of Utah Health
        • 接触：
        • 首席研究员：
          • Irma Fleming, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Ketamine-Assisted Psychotherapy
All 12 study participants will be assigned to receive KAP treatment.
行为的：Preparatory Session
A preparatory session will be completed with the subject by a trained psychotherapist to prepare them for the 1st Ketamine treatment
药品：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.
药品：Ketamine-assisted Psychotherapy Session #2
The second study intervention for KAP will include a 2.5-3 hour therapy session.
行为的：Integration Session
An integration session will be held with a trained psychotherapist after the 2nd Ketamine administration

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Safety and Tolerability defined by the number of participants with treatment-related adverse events
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Feasibility - Recruitment rate
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Irma Fleming

合作者

University of Utah

调查人员

  • 首席研究员：Irma Fleming, MD、The University of Utah
  • 首席研究员：Benjamin Lewis, MD、The University of Utah

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月24日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2028年4月1日

研究注册日期

首次提交

2026年4月6日

首先提交符合 QC 标准的

2026年4月28日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 192679

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅