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

NCT07218757 | Recruiting

• 1 other identifier: 1UG3AT013497-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain

Keywords

Chronic Pain; Psychotherapy; Musculoskeletal Disease; Mental Health

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (3)

• Change in "pain attributions" from baseline to 10 weeks, 6 months, and 12 months post baseline

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

• Change in "emotional processing" from baseline to 10 weeks, 6 months, and 12 months post baseline

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

• Change in "kinesiophobia" from baseline to 10 weeks, 6 months, and 12 months post baseline.

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

Study Arms (2)

Emotional awareness and expression therapy (EAET)

EXPERIMENTAL

Seeks 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.

Behavioral: Emotional Awareness and Expression Therapy (EAET)

Cognitive behavioral therapy for chronic pain (CBT-CP)

ACTIVE COMPARATOR

Seeks 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.

Behavioral: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

Interventions

Emotional Awareness and Expression Therapy (EAET) BEHAVIORAL

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.

Emotional awareness and expression therapy (EAET)

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) BEHAVIORAL

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.

Cognitive behavioral therapy for chronic pain (CBT-CP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: collaborator
• University of Utah: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Texas Health Science Center at San Antonio (South Texas) ADRC: collaborator
• VA Greater Los Angeles Healthcare System: collaborator
• Yale University: collaborator
• University of California, Los Angeles: lead
• Greater Los Angeles Veterans Research and Education Foundation: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain; Musculoskeletal Diseases; Psychological Well-Being

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Brandon C Yarns, MD, MS

CONTACT

310 268 3304; VAChronicPainMultiStudy@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2025
• First Posted: October 20, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)