Phase 1 Pilot of a Pragmatic Trial of EAET for Veterans With Chronic Pain

Not Applicable

Not yet recruiting

• Conditions: Musculoskeletal Pain

• Registration Number: NCT07218757
• Lead Sponsor: University of California, Los Angeles

Brief Summary

About one in three Veterans lives with long-term (chronic) pain, and many of them also struggle with past trauma and mental health issues like depression, anxiety, or PTSD. Emotional Awareness and Expression Therapy (EAET) is a type of talk therapy that helps people understand and express their emotions, especially those linked to past trauma. This therapy has been shown to help reduce pain and improve mental health.

So far, multiple studies have tested EAET in both Veterans and civilians, and the results have been promising. EAET has helped people feel less pain, move better, and experience fewer mental health symptoms. Because of these strong results, the U.S. Department of Health \& Human Services named EAET a Best Practice for managing pain in 2019.

Two earlier studies at a VA hospital in Los Angeles found that EAET worked even better than another well-known therapy called cognitive behavioral therapy for chronic pain (CBT-CP) for older Veterans. However, those studies were done in tightly controlled settings. Now, researchers want to see if EAET works just as well when it's used in everyday healthcare settings, by different types of doctors and therapists.

This new project will happen in two parts, but we will only focus on the first part in this entry: In the first part (a 1-year phase), doctors and therapists at up to 7 VA hospitals across the country will be trained to use EAET. They will then try it out with Veterans to see how well it works and how easy it is to use in real clinics. Veterans, doctors, and other staff will be asked for feedback to learn what helps or gets in the way of using EAET.

Detailed Description

Chronic pain is present in nearly one-third of Veterans and is frequently accompanied by comorbid trauma and mental health symptoms. Emotional awareness and expression therapy (EAET) is an evidence-based psychological treatment for chronic pain that was developed to directly target comorbid trauma and mental health symptoms with the goal of reducing or eliminating chronic pain. Multiple controlled and uncontrolled efficacy trials of EAET in Veterans and civilians have shown EAET can produce robust effects on improving outcomes that include pain severity, pain interference, depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms. Consequently, EAET was recommended as a Pain Management Best Practice by the U.S. Department of Health \& Human Services in 2019. Moreover, in two single-site efficacy trials conducted at VA Greater Los Angeles Healthcare System, EAET was found to be superior on several outcomes to gold- standard cognitive behavioral therapy for chronic pain (CBT-CP) among older Veterans with chronic pain. Yet these more tightly controlled trials may not reflect the true effectiveness of EAET when implemented by diverse clinicians. The overall goal of the proposed project is to conduct a rigorous and comprehensive evaluation of EAET delivered in usual care settings. The project will proceed in two phases, but this entry will focus on the first phase: During a 1-year UG3 phase, clinicians at up to 7 geographically diverse VA healthcare systems will be trained in EAET via an EAET learning collaborative, and a pilot randomized clinical trial of EAET and CBT-CP will be performed at each site to confirm feasibility. In addition, a formative evaluation will be conducted to engage clinicians, administrators, and Veterans and to identify barriers and facilitators to implementation.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-16
• Study First Submitted QC: 2025-10-16
• Study First Posted: 2025-10-20
• Last Update Submitted: 2025-10-21
• Last Update Posted: 2025-10-23
• Study Start: 2026-01-05
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Veteran at one of 7 VA healthcare systems;
• Age 18 years or older;
• At least 3 months of musculoskeletal pain, defined using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic codes, which include the following M-code diagnoses: back pain, fibromyalgia, limb pain, neck pain; R-code diagnoses: pelvic and perineal pain, jaw pain; and G-code diagnoses: tension headaches; and
• Pain of at least moderate severity, defined as ≥4 "on average" on the 0-10 Numeric Pain Rating Scale

Exclusion Criteria

• Poorly controlled major psychiatric illness (e.g., schizophrenia, bipolar I disorder with acute psychotic symptoms, severe manic or depressive episode listed as active in CPRS);
• Active suicide or violence risk (e.g., currently suicidal or homicidal ideation, intent, or plans);
• Active severe drug/alcohol use disorder (e.g., drinking more than intended, tried to stop but couldn't, spent significant time drinking or being sick from aftereffects, wanted drink so badly you couldn't think of anything else, interference with home or work life, continued to drink despite problems, given up on activities, dangerous situations, withdrawal and/or tolerance); and
• Current participation in CBT-CP or EAET, or participation in either intervention in the last 6 months, via clinical care or another research study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in "pain severity" from baseline to 10 weeks, 6 months, and 12 months post baseline	Baseline, along with 10 weeks, 6 months, and 12 months post baseline	Brief Pain Inventory (BPI) Pain Severity. Average of four self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be).

Secondary Outcome Measures

Name	Time	Method
Change in "pain Interference" from baseline to 10 weeks, 6 months, and 12 months post baseline	Baseline, along with 10 weeks, 6 months, and 12 months post baseline	BPI Pain Interference. Average of seven self-report items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each item is scored 0-10 (0 = does not interfere; 10 = completely interferes).
Change in "total pain impact" from baseline to 10 weeks, 6 months, and 12 months post baseline	Baseline, along with 10 weeks, 6 months, and 12 months post baseline	Pain, Enjoyment of Life and General Activity scale. Average of three self-report items: average pain intensity, interference with enjoyment of life, and interference with general activity over the past week. Each item is scored 0-10 (0 = no pain or no interference; 10 = pain as bad as you can imagine or completely interferes).
Change in "physical functioning" from baseline to 10 weeks, 6 months, and 12 months post baseline	Baseline, along with 10 weeks, 6 months, and 12 months post baseline	PROMIS Physical Functioning Short Form 6b. Total of six self-report items assessing ability to perform daily physical activities such as carrying groceries, climbing stairs, walking, and self-care. Each item is scored on a 5-point scale (1 = unable to do; 5 = without any difficulty), with higher scores indicating better physical functioning.
Change in "sleep" from baseline to 10 weeks, 6 months, and 12 months post baseline	Baseline, along with 10 weeks, 6 months, and 12 months post baseline	PROMIS Sleep Disturbance 6a. Total of six self-report items assessing perceptions of sleep quality, difficulty falling asleep, and sleep satisfaction over the past 7 days. Each item is scored on a 5-point scale (e.g., 1 = not at all; 5 = very much), with higher scores indicating greater sleep disturbance.
Change in "fatigue" from baseline to 10 weeks, 6 months, and 12 months post baseline	Baseline, along with 10 weeks, 6 months, and 12 months post baseline	PROMIS Fatigue 7a. Total of seven self-report items assessing the frequency and impact of fatigue over the past 7 days, including tiredness, energy level, and how fatigue interferes with daily activities. Each item is scored on a 5-point scale (e.g., 1 = not at all; 5 = very much), with higher scores indicating greater fatigue.
Change in "pain catastrophizing" from baseline to 10 weeks, 6 months, and 12 months post baseline	Baseline, along with 10 weeks, 6 months, and 12 months post baseline	Pain Catastrophizing Scale-Short Form-6 Item. Total of six self-report items assessing catastrophic thinking related to pain, including rumination, magnification, and helplessness. Each item is scored 0-4 (0 = not at all; 4 = all the time), with higher scores indicating greater pain catastrophizing.
Change in "depression symptoms" from baseline to 10 weeks, 6 months, and 12 months post baseline	Baseline, along with 10 weeks, 6 months, and 12 months post baseline	Patient Health Questionnaire-8 Item. Total of eight self-report items assessing symptoms of depression over the past 2 weeks, including mood, interest, sleep, energy, appetite, self-worth, concentration, and psychomotor changes. Each item is scored 0-3 (0 = not at all; 3 = nearly every day), yielding a total score between 0 and 24, with higher scores indicating more severe depressive symptoms.
Change in "anxiety symptoms" from baseline to 10 weeks, 6 months, and 12 months post baseline	Baseline, along with 10 weeks, 6 months, and 12 months post baseline	Generalized Anxiety Disorder Scale-7 Item. Total of seven self-report items assessing symptoms of generalized anxiety over the past 2 weeks, including nervousness, uncontrollable worry, excessive worry, trouble relaxing, restlessness, irritability, and fear of something awful happening. Each item is scored 0-3 (0 = not at all; 3 = nearly every day), yielding a total score between 0 and 21, with higher scores indicating more severe anxiety symptoms.
Change in "PTSD symptoms" from baseline to 10 weeks, 6 months, and 12 months post baseline	Baseline, along with 10 weeks, 6 months, and 12 months post baseline	PTSD Checklist for DSM-5 (PCL-5). Total of 20 self-report items assessing PTSD symptoms over the past month, including intrusion, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. Each item is scored 0-4 (0 = not at all; 4 = extremely), yielding a total score between 0 and 80, with higher scores indicating greater PTSD symptom severity.
Change in "substance use screener" from baseline to 10 weeks, 6 months, and 12 months post baseline	Baseline, along with 10 weeks, 6 months, and 12 months post baseline	Tobacco, Alcohol, Prescription Medication, and Other Substance use first stage screener (TAPS-1). Single self-report item assessing frequency of use for tobacco, alcohol, prescription medications, and other substances over the past 12 months or since the last assessment point. Each item is scored on a scale from 0 to 5 (0 = never; 5 = daily or almost daily), with higher scores indicating greater substance use frequency.
Change in "World Health Organization Quality of life" from baseline to 10 weeks, 6 months, and 12 months post baseline	Baseline, along with 10 weeks, 6 months, and 12 months post baseline	World Health Organization-Quality of Life (WHOQOL-2). Two self-report items assessing overall quality of life and general health. Each item is scored on a 5-point scale (e.g., 1 = very poor/very dissatisfied; 5 = very good/very satisfied), with higher scores indicating better quality of life.
"Patient Global Impression of Change" at 10 weeks, 6 months, and 12 months post baseline	10 weeks, 6 months, and 12 months post baseline	Patient Global Impression of Change (PGIC). A single self report item assessing the Patient Global Impression of Change as a result of treatment. Items range from 1-7 (1 = No change (or condition has gotten worse); 7 = A great deal better and a considerable improvement that has made all the difference).

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States