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

NCT ID: NCT05989230

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-28
• Study Completion Date: 2028-02-01

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.

Conditions

Orthopaedic Trauma; Chronic Pain; Musculoskeletal Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Emotional Awareness and Expression Therapy

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

Group Type: EXPERIMENTAL

Emotional Awareness and Expression Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

EAET

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Aaron, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Aaron, PhD

Role: CONTACT

Phone: 410-502-2428

Email: raaron4@jhmi.edu

Stephen Wegener, PhD

Role: CONTACT

Email: swegener@jhmi.edu

Facility Contacts

Rachel Aaron

Role: primary

References

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.

Reference Type: DERIVED

PMID: 40090682 (View on PubMed)

Other Identifiers

K23HD104934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00277255

Identifier Type: -

Identifier Source: org_study_id