KALM-B: Ketamine-assisted Psychotherapy (KAP) to Lessen Morbidity After Burn Injury
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Safety and Tolerability defined by the number of participants with treatment-related adverse events
研究概览
简要总结
A study looking at the safety and tolerability of KAP (Ketamine-Assisted Psychotherapy) in the burn population.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Ketamine-Assisted Psychotherapy
All 12 study participants will be assigned to receive KAP treatment.
干预措施: Preparatory Session (Behavioral)
Ketamine-Assisted Psychotherapy
All 12 study participants will be assigned to receive KAP treatment.
干预措施: Ketamine-assisted Psychotherapy Session #1 (Drug)
Ketamine-Assisted Psychotherapy
All 12 study participants will be assigned to receive KAP treatment.
干预措施: Ketamine-assisted Psychotherapy Session #2 (Drug)
Ketamine-Assisted Psychotherapy
All 12 study participants will be assigned to receive KAP treatment.
干预措施: Integration Session (Behavioral)
结局指标
主要结局
Safety and Tolerability defined by the number of participants with treatment-related adverse events
时间窗: 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.
次要结局
- Feasibility - Recruitment rate(From study opening to completion of recruitment, up to 24 months)
- Feasibility - Treatment Completion Rate(From enrollment through completion of all scheduled KAP sessions, assessed up to 12 weeks)
- Feasibility - Follow-up Completion Rate(From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months))
- Timeliness of Intervention Delivery(Baseline (from injury to initiation of treatment; up to 12 months))
- Opioid Use(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)(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)(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(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(From baseline through 6 months post-treatment follow-up (assessments at 1, 3, and 6 months))
研究者
Irma Fleming
Assistant Professor
University of Utah