Clinical trial NCT05989230: Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma
Official title: Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthopaedic Trauma
Chronic Pain
Musculoskeletal Injury
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of Enrollment
timeFrame: 24 months
measure: Feasibility of Retention
timeFrame: 24 months
measure: Feasibility of Recruitment
timeFrame: 24 months
measure: Percentage of patient session attendance
timeFrame: 8 weeks
measure: Therapist Fidelity (Questionnaire developed by study team)
timeFrame: 8 Weeks
measure: Percentage of patients who indicate patient satisfaction and acceptability
timeFrame: 8 Weeks
measure: Feasibility of Study Assessment
timeFrame: 1 Week
measure: Feasibility of Study Assessment
timeFrame: 8 Weeks
measure: Feasibility of Study Assessment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Rachel Aaron, PhD
role: PRINCIPAL_INVESTIGATOR
References: