Johns Hopkins School of Medicine
Baltimore, Maryland, 21287, United States
Location status: Recruiting
NCT Number: NCT05989230
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21287, United States
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 24 months
Feasibility of enrollment will be measured by percentage of eligible patients who enroll in the study.
Time frame: 24 months
Feasibility of retention will be measured by percentage of participants who are retained over the duration of the study.
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.
Time frame: 8 weeks
Percentage of patients who complete 6 of 8 total EAET sessions.
Time frame: 8 Weeks
Percentage of treatment fidelity across all treatment sessions (study therapist self-report using questionnaire developed by study team).
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.
Time frame: 1 Week
Measured by percent of pre-treatment assessments completed by participants.
Time frame: 8 Weeks
Measured by percent of post-treatment assessments completed by participants.
Time frame: 12 months
Measured by percent of follow-up assessments completed by participants.
Contact information is provided by the study sponsor or research team.
Rachel Aaron, PhD
CONTACT
Stephen Wegener, PhD
CONTACT
Johns Hopkins University
Other
Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma: A Pilot Feasibility Study
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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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