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

NCT05989230 | Recruiting

• 2 other identifiers: IRB00277255K23HD104934
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopaedic Trauma; Chronic Pain; Musculoskeletal Injury

Outcome Measures

Primary Outcomes (9)

• Feasibility of Enrollment

  Feasibility of enrollment will be measured by percentage of eligible patients who enroll in the study.

  24 months

• Feasibility of Retention

  Feasibility of retention will be measured by percentage of participants who are retained over the duration of the study.

  24 months

• Feasibility of Recruitment

  Feasibility of Recruitment will be measured by the enrollment of a full sample within two years of the start of the enrollment period.

  24 months

• Percentage of patient session attendance

  Percentage of patients who complete 6 of 8 total EAET sessions.

  8 weeks

• Therapist Fidelity (Questionnaire developed by study team)

  Percentage of treatment fidelity across all treatment sessions (study therapist self-report using questionnaire developed by study team).

  8 Weeks

• Percentage of patients who indicate patient satisfaction and acceptability

  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.

  8 Weeks

• Feasibility of Study Assessment

  Measured by percent of pre-treatment assessments completed by participants.

  1 Week

• Feasibility of Study Assessment

  Measured by percent of post-treatment assessments completed by participants.

  8 Weeks

• Feasibility of Study Assessment

  Measured by percent of follow-up assessments completed by participants.

  12 months

Study Arms (1)

Emotional Awareness and Expression Therapy

EXPERIMENTAL

Emotional Awareness and Expression Therapy (EAET) is a non-pharmacological intervention designed to address persistent pain.

Behavioral: Emotional Awareness and Expression Therapy

Interventions

Emotional Awareness and Expression Therapy BEHAVIORAL

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.

Also known as: EAET

Emotional Awareness and Expression Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel Aaron, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Aaron, PhD

CONTACT

410-502-2428; raaron4@jhmi.edu

Stephen Wegener, PhD

CONTACT

swegener@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 28, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)