A Pragmatic Trial of EAET for Veterans With Chronic Pain
ConditionMusculoskeletal Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles
About this trial
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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Emotional Awareness and Expression Therapy (EAET)
BehavioralTalk 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)
BehavioralTalk 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.
Treatment groups
672 Participants
are divided into 2 treatment groupsGroup A: Emotional awareness and expression therapy (EAET)Experimental treatment 1 intervention
Group B: Cognitive behavioral therapy for chronic pain (CBT-CP)Active comparator 1 intervention
Trial outcomes
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).
Time frame
Baseline, along with 10 weeks, 6 months, and 12 months post baselineSecondary outcomes
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).
Time frame
Baseline, along with 10 weeks, 6 months, and 12 months post baseline2
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).
Time frame
Baseline, along with 10 weeks, 6 months, and 12 months post baseline3
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.
Time frame
Baseline, along with 10 weeks, 6 months, and 12 months post baseline4
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.
Time frame
Baseline, along with 10 weeks, 6 months, and 12 months post baselineOther outcomes
1
Change in "pain attributions" from baseline to 10 weeks, 6 months, and 12 months post baseline
Chronic Pain Attributions Scale v2 Short Form. Six self-report items assessing beliefs about the causes and consequences of chronic pain, including factors such as controllability and permanence. Three items are open ended and ask for write-in of the three main causes of their pain. The other three items are individually scored on a Likert scale (e.g., 1 = strongly disagree; 5 = strongly agree), with higher scores reflecting stronger endorsement of specific pain attributions.
Time frame
Baseline, along with 10 weeks, 6 months, and 12 months post baseline2
Change in "emotional processing" from baseline to 10 weeks, 6 months, and 12 months post baseline
Emotional Processing Scale-15. Total of 15 self-report items assessing difficulties in processing emotions across multiple domains, including suppression, avoidance, and unregulated emotional responses. Each item is scored on a 0-4 scale (0 = strongly disagree; 4 = strongly agree), with higher scores indicating greater problems with emotional processing.
Time frame
Baseline, along with 10 weeks, 6 months, and 12 months post baseline3
Change in "kinesiophobia" from baseline to 10 weeks, 6 months, and 12 months post baseline.
Tampa Scale for Kinesiophobia-11. Total of 11 self-report items assessing fear of movement or re-injury related to physical activity. Each item is scored on a 4-point scale (1 = strongly disagree; 4 = strongly agree), with higher scores indicating greater kinesiophobia (fear of movement).
Time frame
Baseline, along with 10 weeks, 6 months, and 12 months post baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
University of Texas Health Science Center at San Antonio (South Texas) ADRC
Collaborator
University of Colorado, Denver
Collaborator
University of Utah
Collaborator
VA Greater Los Angeles Healthcare System
Collaborator
Yale University
Collaborator
Greater Los Angeles Veterans Research and Education Foundation
Collaborator
Source ClinicalTrials.gov