Orthopaedic TraumaNCT05989230
Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma
A study testing Emotional Awareness and Expression Therapy in people with Orthopaedic Trauma and Chronic Pain, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopaedic Trauma, Chronic Pain, Musculoskeletal Injury
- What is being tested?
- Emotional Awareness and Expression Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stephen Wegener, PhD contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Rachel Aaron, 704-533-1631, raaron4@jhmi.edu
About this study
Official title: Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma: A Pilot Feasibility Study
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.
Read the 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
- Being tested
- Emotional Awareness and Expression Therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Awareness and Expression TherapyBehavioural
Also called EAET
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.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Awareness and Expression Therapy | Experimental | Emotional Awareness and Expression Therapy (EAET) is a non-pharmacological intervention designed to address persistent pain. Receives: Behavioral: Emotional Awareness and Expression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Enrollment
Feasibility of enrollment will be measured by percentage of eligible patients who enroll in the study.
Measured: 24 months
Feasibility of Retention
Feasibility of retention will be measured by percentage of participants who are retained over the duration of the study.
Measured: 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.
Measured: 24 months
Percentage of patient session attendance
Percentage of patients who complete 6 of 8 total EAET sessions.
Measured: 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).
Measured: 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.
Measured: 8 Weeks
Feasibility of Study Assessment
Measured by percent of pre-treatment assessments completed by participants.
Measured: 1 Week
Feasibility of Study Assessment
Measured by percent of post-treatment assessments completed by participants.
Measured: 8 Weeks
Feasibility of Study Assessment
Measured by percent of follow-up assessments completed by participants.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start28 Aug 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopaedic TraumaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Rachel Aaron, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989230
- Sponsor's protocol ID
- IRB00277255
- Other IDs
- K23HD104934
- Status last verified
- Jun 2026
- First submitted
- 3 Aug 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40090682
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT05989230
- Acronym / sponsor ID
- IRB00277255
- Conditions
- Orthopaedic Trauma, Chronic Pain, Musculoskeletal Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emotional Awareness and Expression Therapy | Experimental | Behavioral: Emotional Awareness and Expression TherapyEmotional Awareness and Expression Therapy (EAET) is a non-pharmacological intervention designed to address persistent pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- One or more acute orthopedic injuries
- The patient sustained an orthopedic injury including, but not limited to:
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Awareness and Expression TherapyAlso: EAETThe 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. | Behavioural | Emotional Awareness and Expression Therapy |
Primary outcome
Feasibility of Enrollment
Time frame: 24 months
Feasibility of enrollment will be measured by percentage of eligible patients who enroll in the study.
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.
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.
Percentage of patient session attendance
Time frame: 8 weeks
Percentage of patients who complete 6 of 8 total EAET sessions.
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).
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.
Feasibility of Study Assessment
Time frame: 1 Week
Measured by percent of pre-treatment assessments completed by participants.
Feasibility of Study Assessment
Time frame: 8 Weeks
Measured by percent of post-treatment assessments completed by participants.
Feasibility of Study Assessment
Time frame: 12 months
Measured by percent of follow-up assessments completed by participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 40090682Ravyts 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Wegener, PhD contact
Rachel Aaron, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Awareness and Expression Therapy in people with Orthopaedic Trauma and Chronic Pain, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Aaron, PhD (410-502-2428, raaron4@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Enrollment (time frame: 24 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05989230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.