Chronic Pain, Musculoskeletal Injury, Orthopaedic Trauma
Conditions
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.
Interventions
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, weekly psychotherapy visits.
Sponsors
Johns Hopkins University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Enrollment | 24 months | Feasibility of enrollment will be measured by percentage of eligible patients who enroll in the study. |
| Feasibility of Retention | 24 months | Feasibility of retention will be measured by percentage of participants who are retained over the duration of the study. |
| Feasibility of Recruitment | 24 months | Feasibility of Recruitment will be measured by the enrollment of a full sample within two years of the start of the enrollment period. |
| Percentage of patient session attendance | 8 weeks | Percentage of patients who complete 6 of 8 total EAET sessions. |
| Therapist Fidelity (Questionnaire developed by study team) | 8 Weeks | Percentage of treatment fidelity across all treatment sessions (study therapist self-report using questionnaire developed by study team). |
| Percentage of patients who indicate patient satisfaction and acceptability | 8 Weeks | Percentage of patients who indicate treatment acceptability on the Treatment Evaluation Inventory-Short Form. This is a 9-item measure and participants respond using a 1-5 point likert scale for a possible total range of 9-45. Higher scores indicate greater satisfaction and acceptability. |
| Feasibility of Study Assessment | 1 Week | Measured by percent of pre-treatment assessments completed by participants. |
Countries
United States
Contacts
CONTACTRachel Aaron, PhD
CONTACTStephen Wegener, PhD
PRINCIPAL_INVESTIGATORRachel Aaron, PhD
Johns Hopkins University
Outcome results
None listed