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

Primary Purpose

Orthopaedic Trauma, Chronic Pain, Musculoskeletal Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Emotional Awareness and Expression Therapy
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopaedic Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Emotional Awareness and Expression Therapy

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Feasibility of Enrollment
    Feasibility of enrollment will be measured by percentage of eligible patients who enroll in the study.
    Feasibility of Retention
    Feasibility of retention will be measured by percentage of participants who are retained over the duration of the study.
    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.
    Percentage of patient session attendance
    Percentage of patients who complete 6 of 8 total EAET sessions.
    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).
    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.
    Feasibility of Study Assessment
    Measured by percent of pre-treatment assessments completed by participants.
    Feasibility of Study Assessment
    Measured by percent of post-treatment assessments completed by participants.
    Feasibility of Study Assessment
    Measured by percent of follow-up assessments completed by participants.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 3, 2023
    Last Updated
    August 3, 2023
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05989230
    Brief Title
    Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma
    Official Title
    Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma: A Pilot Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2024 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Orthopaedic Trauma, Chronic Pain, Musculoskeletal Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Emotional Awareness and Expression Therapy
    Arm Type
    Experimental
    Arm Description
    Emotional Awareness and Expression Therapy (EAET) is a non-pharmacological intervention designed to address persistent pain.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Emotional Awareness and Expression Therapy
    Other Intervention Name(s)
    EAET
    Intervention Description
    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 Information:
    Title
    Feasibility of Enrollment
    Description
    Feasibility of enrollment will be measured by percentage of eligible patients who enroll in the study.
    Time Frame
    24 months
    Title
    Feasibility of Retention
    Description
    Feasibility of retention will be measured by percentage of participants who are retained over the duration of the study.
    Time Frame
    24 months
    Title
    Feasibility of Recruitment
    Description
    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
    Title
    Percentage of patient session attendance
    Description
    Percentage of patients who complete 6 of 8 total EAET sessions.
    Time Frame
    8 weeks
    Title
    Therapist Fidelity (Questionnaire developed by study team)
    Description
    Percentage of treatment fidelity across all treatment sessions (study therapist self-report using questionnaire developed by study team).
    Time Frame
    8 Weeks
    Title
    Percentage of patients who indicate patient satisfaction and acceptability
    Description
    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
    8 Weeks
    Title
    Feasibility of Study Assessment
    Description
    Measured by percent of pre-treatment assessments completed by participants.
    Time Frame
    1 Week
    Title
    Feasibility of Study Assessment
    Description
    Measured by percent of post-treatment assessments completed by participants.
    Time Frame
    8 Weeks
    Title
    Feasibility of Study Assessment
    Description
    Measured by percent of follow-up assessments completed by participants.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rachel Aaron, PhD
    Phone
    410-502-2428
    Email
    raaron4@jhmi.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stephen Wegener, PhD
    Email
    swegener@jhmi.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rachel Aaron, PhD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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