NCT05989230 · Johns Hopkins University
Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma
What this study is about
The purpose of this single-treatment group$1 trial is to determine the feasibility of emotional awareness and expression therapy (EAET) for individuals with persistent pain following orthopedic trauma.
View original scientific description
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.
Interventions
BEHAVIORAL
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, weekly psychotherapy visits.
Primary outcome measures
Feasibility of Enrollment
Time frame: 24 months
Feasibility of enrollment will be measured by percentage of eligible patients who enroll in the study.
Feasibility of Retention
Time frame: 24 months
Feasibility of retention will be measured by percentage of participants who are retained over the duration of the study.
Feasibility of Recruitment
Time frame: 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
Time frame: 8 weeks
Percentage of patients who complete 6 of 8 total EAET sessions.
Therapist Fidelity (Questionnaire developed by study team)
Time frame: 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
Time frame: 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
Time frame: 1 Week
Measured by percent of pre-treatment assessments completed by participants.
Feasibility of Study Assessment
Time frame: 8 Weeks
Measured by percent of post-treatment assessments completed by participants.
Feasibility of Study Assessment
Time frame: 12 months
Measured by percent of follow-up assessments completed by participants.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations