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NCT Number: NCT05989230

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Rachel Aaron

CONTACT

[email protected]

704-533-1631

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: EAET

Primary outcomes

  1. Feasibility of Enrollment

    Time frame: 24 months

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

  2. 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.

  3. 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.

  4. Percentage of patient session attendance

    Time frame: 8 weeks

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

  5. 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).

  6. 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.

  7. Feasibility of Study Assessment

    Time frame: 1 Week

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

  8. Feasibility of Study Assessment

    Time frame: 8 Weeks

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

  9. Feasibility of Study Assessment

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Aaron, PhD

CONTACT

[email protected]

410-502-2428

Stephen Wegener, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Official study title

Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma: A Pilot Feasibility Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2023
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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