Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma

Официальное название

Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma: A Pilot Feasibility Study

Обзор

The purpose of this single-arm trial is to determine the feasibility of emotional awareness and expression therapy (EAET) for individuals with persistent pain following orthopedic trauma. As part of this study, participants will be asked to attend weekly EAET treatment sessions and complete assessments (including pre-treatment, post-treatment, and follow-up) consisting of questionnaires and sensory testing procedures.

Подробное описание

Orthopedic trauma, resulting in severe injuries such as multiple fractures or amputation, occurs in approximately 3 million people annually in the United States; about half of these people experience persistent pain and psychological distress (depression, anxiety, posttraumatic stress disorder \[PTSD\] symptoms) 6 to 12 months post injury. Pain and distress exacerbate one another, are likely to persist, and relate to disability: half of patients report substantial disability 7 years post trauma. Medical interventions such as surgery promote survival; however, there is an urgent need to develop targeted psychological interventions to treat these disabling symptoms.

Few psychological interventions are available to treat pain and distress following orthopedic trauma. Emotional Awareness and Expression Therapy (EAET) is an 8-week psychological intervention recently developed for chronic pain conditions characterized by central sensitization. EAET is unique in treating pain and mood by targeting emotion regulation processes related to traumatic life events. Such events are ubiquitous following orthopedic trauma and recent findings show that EAET results in improvements in pain and mood; thus, it may be uniquely effective to address the needs of orthopedic trauma survivors. However, there are documented barriers to implementing psychological interventions in this population, so the feasibility of EAET is unknown. The purpose of this study is to test the feasibility of delivery and assessment of EAET for orthopedic trauma survivors with persistent pain in a single-arm trial. As part of this study, participants will be asked to do the following things:

* Attend EAET treatment with a mental health provider. Session will last around 60 minutes each. * Complete baseline, post-treatment, and follow-up assessments. These assessments will ask patients to complete questionnaires related to physical and emotional health, as well as receive sensory testing in order to examine pain processing. The questionnaires will take 20-25 minutes. The sensory testing procedures will take about 20 minutes.

Вмешательства

• Поведенческое Emotional Awareness and Expression Therapy
  The goal of EAET is to increase awareness of uncomfortable emotions that are often linked to stressful past experiences (e.g., anger, sadness, fear) and learn adaptive ways to experience and express those emotions, in a safe and controlled environment. Core treatment components include pain education, drawing associations between the experience of pain and emotion, and experiencing and expressing emotions via imaginary, in vivo, and real life exposures. EAET will be delivered via 8, 60-minute, w

Первичные конечные точки

• Feasibility of Enrollment [Срок оценки: 24 months]
• Feasibility of Retention [Срок оценки: 24 months]
• Feasibility of Recruitment [Срок оценки: 24 months]
• Percentage of patient session attendance [Срок оценки: 8 weeks]
• Therapist Fidelity (Questionnaire developed by study team) [Срок оценки: 8 Weeks]
• Percentage of patients who indicate patient satisfaction and acceptability [Срок оценки: 8 Weeks]
• Feasibility of Study Assessment [Срок оценки: 1 Week]
• Feasibility of Study Assessment [Срок оценки: 8 Weeks]
• Feasibility of Study Assessment [Срок оценки: 12 months]

Критерии участия

Критерии включения

• One or more acute orthopedic injuries
• The patient sustained an orthopedic injury including, but not limited to:

• Pelvic or acetabulum fracture
• Open/displaced comminuted fracture of long bones
• Upper extremity injuries with a major nerve involvement
• Injuries with significant injuries to major blood vessels
• Traumatic amputation of big toe, thumb, or proximal to the wrist or ankle.
• Initial admission to the trauma or orthopedic center/service of the participating hospital OR all necessary screening and patient characteristic data available in medical record (determination based on information available at time of enrollment)
• 18 years old or older
• Received operative fixation for at least one acute orthopaedic injury at a participating hospital. Patients should be recruited at the time of primary injury, not revision or complication surgery
• Average Brief Pain Inventory Score > 3/10
• Presence of pain most days (> 3 days/week) for past three months

Критерии исключения

• peri-prosthetic fractures of the femur (regardless of etiology)
• non-ambulatory due to an associated spinal cord injury
• non-ambulatory pre-injury
• currently pregnant
• moderate or severe traumatic brain injury (TBI), as evidenced by intracranial hemorrhage present on admission CT
• major amputation(s) of the upper or lower extremities
• non-English speaking
• Likely to have severe problems with maintaining follow-up for any of the following reasons:

• The patient has been diagnosed with a severe psychiatric conditions
• The patient has current alcohol and/or drug addiction based on medical record or patient self-report.
• The patient is intellectually challenged without adequate family support
• The patient lives outside the hospital's catchment area
• The patient follow-up is planned at another medical center
• The patient is a prisoner
• The patient is homeless
• Other

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Johns Hopkins School of Medicine — Baltimore

Публикации

• Ravyts SG, Carnahan N, Campbell C, Castillo R, Wegener S, Rassu FS, Lumley MA, Aaron R. Emotional awareness and expression therapy (EAET) for chronic pain following traumatic orthopaedic injury and surgery: study protocol for a single-arm feasibility clinical trial. BMJ Open. 2025 Mar 15;15(3):e093102. doi: 10.1136/bmjopen-2024-093102. PMID 40090682

Идентификаторы

NCT: NCT05989230 · IRB00277255 · K23HD104934

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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