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Musculoskeletal PainNCT07218757

A Pragmatic Trial of EAET for Veterans With Chronic Pain

A study testing Emotional Awareness and Expression Therapy (EAET) and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) in people with Musculoskeletal Pain, run by University of California, Los Angeles at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Musculoskeletal Pain
What is being tested?
Emotional Awareness and Expression Therapy (EAET) and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
672 participants
Where
1 siteUnited States
Study dates
2 Jan 2026to Jul 2030
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

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brandon C Yarns, MD, MS contact

310 268 3304

VAChronicPainMultiStudy@va.gov

United States1 site, 1 recruiting
  • University of California, Los Angeles

    Los Angeles, California, 90095

    Brandon C Yarns C Yarns, MD, MS, 310 268 3304, VAChronicPainMultiStudy@va.gov

    Recruiting

Other trials in United States

About this study

Official title: A Pragmatic Trial of Emotional Awareness and Expression Therapy for Veterans With Chronic Pain: Phase 1

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.

Read more

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.

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.

Read the 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: 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. In Phase 2, we are conducting a pragmatic multisite randomized clinical trial.

Being tested
Emotional Awareness and Expression Therapy (EAET), Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
Keywords
Chronic Pain, Psychotherapy, Musculoskeletal Disease, Mental Health
Medical subject headings
Musculoskeletal Pain, Chronic Pain, Musculoskeletal Diseases, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional Awareness and Expression Therapy (EAET)Behavioural

    Talk therapy that helps people understand and express their feelings, especially emotions linked to past stress or trauma. The goal is to help reduce long-term pain by dealing with hidden emotional struggles that may be affecting the body.

  • Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)Behavioural

    Talk therapy that helps people learn how their thoughts, feelings, and behaviors affect their pain. It teaches skills to manage pain, reduce stress, and improve daily life.

Study groups in NCT07218757
Study groupRoleWhat they receive
Emotional awareness and expression therapy (EAET)ExperimentalSeeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.
Receives: Behavioral: Emotional Awareness and Expression Therapy (EAET)
Cognitive behavioral therapy for chronic pain (CBT-CP)Active comparatorSeeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.
Receives: Behavioral: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in "pain severity" from baseline to 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).

    Measured: Baseline, along with 10 weeks, 6 months, and 12 months post baseline

Secondary outcomes (12)
  1. Change in "pain Interference" from baseline to 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).

    Measured: Baseline, along with 10 weeks, 6 months, and 12 months post baseline

  2. Change in "total pain impact" from baseline to 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).

    Measured: Baseline, along with 10 weeks, 6 months, and 12 months post baseline

  3. Change in "physical functioning" from baseline to 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.

    Measured: Baseline, along with 10 weeks, 6 months, and 12 months post baseline

  4. Change in "sleep" from baseline to 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.

    Measured: Baseline, along with 10 weeks, 6 months, and 12 months post baseline

  5. Change in "fatigue" from baseline to 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.

    Measured: Baseline, along with 10 weeks, 6 months, and 12 months post baseline

  6. Change in "pain catastrophizing" from baseline to 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.

    Measured: Baseline, along with 10 weeks, 6 months, and 12 months post baseline

  7. Change in "depression symptoms" from baseline to 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.

    Measured: Baseline, along with 10 weeks, 6 months, and 12 months post baseline

  8. Change in "anxiety symptoms" from baseline to 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.

    Measured: Baseline, along with 10 weeks, 6 months, and 12 months post baseline

  9. Change in "PTSD symptoms" from baseline to 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.

    Measured: Baseline, along with 10 weeks, 6 months, and 12 months post baseline

  10. Change in "substance use screener" from baseline to 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.

    Measured: Baseline, along with 10 weeks, 6 months, and 12 months post baseline

  11. Change in "World Health Organization Quality of life" from baseline to 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.

    Measured: Baseline, along with 10 weeks, 6 months, and 12 months post baseline

  12. "Patient Global Impression of Change" at 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).

    Measured: 10 weeks, 6 months, and 12 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2025
  2. Study start2 Jan 2026
  3. Primary completionJul 2030 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized 1:1 either to emotional awareness and expression therapy (EAET) or cognitive behavioral therapy for chronic pain (CBT-CP). The randomization sequence will be generated at the start of the study by the study statistician using a computer randomizer to create seven sets of condition assignments (i.e., stratified by site) in blocks of 12 participants, resulting in 2 experimental groups of 6 participants after each block has been fully allocated. We consider 6 participants optimal because it is large enough to maintain group status even if someone drops out but small enough to provide individualized attention, facilitate scheduling a common group time, and keep the size of the pool to be randomized manageable.
Masking
None (open label)
Enrolment
672 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07218757
Sponsor's protocol ID
UG3/UH3AT013497
Other IDs
1UG3AT013497-01, 4UH3AT03497-02
Status last verified
Aug 2026
First submitted
16 Oct 2025
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Emotional Awareness and Expression Therapy (EAET) and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) in people with Musculoskeletal Pain, run by University of California, Los Angeles 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 4 inclusion and 4 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 24 Aug 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 Brandon C Yarns, MD, MS (310 268 3304, VAChronicPainMultiStudy@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in "pain severity" from baseline to 10 weeks, 6 months, and 12 months post baseline (time frame: Baseline, along with 10 weeks, 6 months, and 12 months post baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 24 Aug 2026.

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