Recruiting

Emotional Awareness

Sponsor:

Johns Hopkins University

Code:

NCT05989230

Conditions

Orthopaedic Trauma

Chronic Pain

Musculoskeletal Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Emotional Awareness and Expression Therapy

Study Details

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

Study ID

NCT05989230

Start date

Aug 28, 2024

Status verified date

Jun, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Emotional Awareness and Expression Therapy

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

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.

Primary outcome measure

  • Feasibility of Enrollment [ Time Frame: 24 months ]
  • Feasibility of Retention [ Time Frame: 24 months ]
  • Feasibility of Recruitment [ Time Frame: 24 months ]
  • Percentage of patient session attendance [ Time Frame: 8 weeks ]
  • Therapist Fidelity (Questionnaire developed by study team) [ Time Frame: 8 Weeks ]
  • Percentage of patients who indicate patient satisfaction and acceptability [ Time Frame: 8 Weeks ]
  • Feasibility of Study Assessment [ Time Frame: 1 Week ]
  • Feasibility of Study Assessment [ Time Frame: 8 Weeks ]
  • Feasibility of Study Assessment [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Rachel Aaron, PhD

410-502-2428raaron4@jhmi.edu

Stephen Wegener, PhD

swegener@jhmi.edu

Locations

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Rachel Aaron

704-533-1631raaron4@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-18.