Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05989230

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Johns Hopkins University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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

Interventions

TypeNameDescription
BEHAVIORALEmotional Awareness and Expression TherapyThe 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.

Timeline

Start date
2024-08-28
Primary completion
2027-08-01
Completion
2028-02-01
First posted
2023-08-14
Last updated
2025-12-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05989230. Inclusion in this directory is not an endorsement.