Emotional Awareness and Expression Therapy for Chronic Pain

Overseen By Stephen Wegener, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Non-ambulatory, Pregnant, Severe TBI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether emotional awareness and expression therapy (EAET) can help individuals with ongoing pain after serious bone injuries, such as fractures or amputations. Participants will attend weekly therapy sessions and complete assessments to determine if this non-drug treatment can improve pain and quality of life. The study targets individuals who have experienced major orthopedic injuries and have felt pain most days for the past three months. As an unphased trial, it offers a unique opportunity for participants to potentially enhance their quality of life through innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Emotional Awareness and Expression Therapy is safe for individuals with chronic pain?

Research shows that Emotional Awareness and Expression Therapy (EAET) safely manages chronic pain. Studies have found that EAET effectively reduces pain and improves daily life, with participants often noticing less pain after completing therapy sessions.

This therapy helps individuals address emotions and stress related to their pain, rather than relying on medication. As a result, serious side effects are rare. Research has shown that EAET reduces pain more effectively than treatments like cognitive behavioral therapy (CBT), with clear improvements by the end of treatment and during follow-ups.

EAET is a non-drug treatment and is generally easy for individuals to handle. No reports of serious unwanted effects have emerged from this therapy, making it a promising option for those seeking alternative ways to manage chronic pain without medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Emotional Awareness and Expression Therapy (EAET) is unique because it tackles chronic pain by focusing on emotional processing rather than relying on medications like opioids or NSAIDs. Unlike traditional pain treatments, which often aim to manage symptoms, EAET encourages patients to explore and express their emotions, which can uncover and address underlying emotional contributors to pain. Researchers are excited about this approach because it offers a non-drug alternative that could potentially provide long-lasting relief by addressing the root causes of chronic pain, rather than just masking the symptoms.

What evidence suggests that Emotional Awareness and Expression Therapy is effective for chronic pain?

Research has shown that Emotional Awareness and Expression Therapy (EAET), the treatment under study in this trial, can alleviate chronic pain. In several studies, EAET has reduced pain more effectively than Cognitive Behavioral Therapy (CBT). One study found that 63% of participants in EAET experienced a noticeable decrease in pain, compared to only 17% in CBT. EAET works by teaching individuals to recognize and express their emotions, which can lead to less pain. High retention rates indicate that most participants continue with EAET. This therapy offers a promising option for those with ongoing pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Rachel Aaron, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults who've had surgery to fix severe bone injuries from trauma and are now dealing with ongoing pain. They should have been treated initially at a participating hospital, not be coming in due to complications or revisions, and their pain scores must average above 3 out of 10.

Inclusion Criteria

I had surgery for a bone injury at a participating hospital.

I have a recent injury to my bones or joints.

I have had a fracture in my pelvis or hip socket.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend weekly EAET treatment sessions with a mental health provider, each lasting around 60 minutes

8 weeks

8 visits (in-person)

Follow-up

Participants complete follow-up assessments including questionnaires and sensory testing to examine pain processing

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Emotional Awareness and Expression Therapy

Trial Overview The study is testing Emotional Awareness and Expression Therapy (EAET) for people with lasting pain after orthopedic trauma. Participants will attend weekly EAET sessions and complete various assessments before, after, and following the therapy.

How Is the Trial Designed?

Group I: Emotional Awareness and Expression Therapy Experimental Treatment 1 Intervention

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

Emotional Awareness and Expression Therapy is already approved in United States for the following indications:

Approved in United States as Emotional Awareness and Expression Therapy for:

• Chronic musculoskeletal pain

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Emotional Awareness and Expression Therapy (EAET) has been shown to effectively reduce pain in patients with chronic pain conditions like fibromyalgia and irritable bowel syndrome, based on recent randomized controlled trials.

EAET demonstrated superior outcomes compared to cognitive-behavioral therapy for fibromyalgia, with high patient retention and rare adverse events, suggesting it could be a preferred treatment option for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotional Awareness and Expression Therapy for Chronic Pain: Rationale, Principles and Techniques, Evidence, and Critical Review. Lumley, MA., Schubiner, H.[2020]

Emotional awareness (EA) is crucial in understanding chronic pain (CP), as it relates to the presence and severity of pain, highlighting the need for emotional processes in pain management.

Psychological interventions that enhance EA and address emotional processing can be effective in treating centrally-mediated chronic pain, suggesting that integrating emotional care into pain treatment could improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotional awareness and other emotional processes: implications for the assessment and treatment of chronic pain. Lumley, MA., Krohner, S., Marshall, LM., et al.[2022]

A single-session telehealth class called 'Pain, Stress, and Emotions' (PSE) using Emotional Awareness and Expression Therapy (EAET) significantly reduced pain intensity and interference in 74 adults with chronic pain, with a medium effect size of 0.60 at 4 weeks.

Participants reported high satisfaction with the PSE class, and one-quarter experienced clinically meaningful pain reduction, suggesting that this easily delivered intervention could be beneficial for managing chronic pain, although further controlled studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Pain, Stress, and Emotions": Uncontrolled trial of a single-session, telehealth, emotional awareness and expression therapy class for patients with chronic pain. Ziadni, MS., Sturgeon, JA., Lumley, MA.[2023]

A pilot study involving 16 older veterans showed that group-based video telehealth Emotional Awareness and Expression Therapy (vEAET) was highly acceptable and feasible, with participants attending an average of 7.4 out of 8 sessions and reporting high satisfaction.

The therapy resulted in significant reductions in pain severity, with 14 out of 16 veterans achieving at least a 30% reduction in pain, and 3 veterans experiencing a 90-100% reduction, indicating strong preliminary efficacy for managing chronic musculoskeletal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video telehealth emotional awareness and expression therapy for older U.S. military veterans with chronic pain: A pilot study. Yarns, BC., Molaie, AM., Lumley, MA., et al.[2023]

Emotional awareness and expression therapy (EAET) significantly reduced pain severity in older veterans with chronic musculoskeletal pain compared to cognitive behavioral therapy (CBT), with 41.7% of EAET patients experiencing over 30% pain reduction post-treatment.

The study involved 53 veterans and showed that EAET not only outperformed CBT in pain reduction but also had small to medium advantages in secondary outcomes like anxiety, suggesting that addressing emotional processing can be beneficial in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotional Awareness and Expression Therapy Achieves Greater Pain Reduction than Cognitive Behavioral Therapy in Older Adults with Chronic Musculoskeletal Pain: A Preliminary Randomized Comparison Trial. Yarns, BC., Lumley, MA., Cassidy, JT., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11911693/

Emotional awareness and expression therapy (EAET) for ... Three recent trials have shown that compared with CBT, EAET resulted in greater improvements in pain intensity23,25 among people with chronic ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819961

Emotional Awareness and Expression Therapy vs CBT for ... Moreover, 63% of EAET participants had clinically significant (at least 30%) posttreatment pain reduction vs only 17% in CBT. Meaning These ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7309024/

Emotional Awareness and Expression Therapy for Chronic Pain Retention in EAET was high (77.2% of patients attended at least 75% of sessions), and somewhat better than in CBT (64% of patients), and over 90 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06865560

Emotional Awareness and Expression Therapy for Chronic ... Pain decreases through increased recognition and expression of emotions, and learning to feel safe in the presence of emotions. The primary aim of the study is ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1505318/full

Internet-delivered emotional awareness and expression ... Response rates (at least 50% symptom reduction) at 12-month follow-up were 25% for somatic symptoms, and 12% for pain intensity. Conclusion: I- ...

6. bmjopen.bmj.com bmjopen.bmj.com/content/15/3/e093102

study protocol for a single-arm feasibility clinical trial EAET is a newly developed psychological intervention designed to treat chronic pain by helping patients process psychological trauma and conflict to reduce ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1064748124000460

Emotional Awareness and Expression Therapy for Older ... Two preliminary trials showed large-to-very-large benefits, including one small randomized clinical trial that showed a significant, large effect size advantage ...

8. academic.oup.com academic.oup.com/painmedicine/article/21/11/2811/5843881?login=true&itm_medium=sidebar&itm_source=trendmd-widget&itm_campaign=Pain_Medicine&itm_content=Pain_Medicine_0

A Preliminary Randomized Comparison Trial | Pain Medicine EAET produced significantly lower pain severity than CBT at post-treatment and follow-up; differences were large (partial η2 = 0.129 and 0.157, ...