Health TrialsbyHealthPanel

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

ConditionsOrthopaedic TraumaChronic PainMusculoskeletal Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

One or more acute orthopedic injuries

Pelvic or acetabulum fracture

Open/displaced comminuted fracture of long bones

Upper extremity injuries with a major nerve involvement

Disqualifiers

peri-prosthetic fractures of the femur (regardless of etiology)

non-ambulatory due to an associated spinal cord injury

non-ambulatory pre-injury

currently pregnant

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Emotional Awareness and Expression TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Enrollment

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

Time frame
24 months
2

Feasibility of Retention

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

Time frame
24 months
3

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.

Time frame
24 months
4

Percentage of patient session attendance

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

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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