Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder

Not Applicable

Recruiting

• Conditions: Chronic Pain; Opioid Use Disorder

• Registration Number: NCT06865560
• Lead Sponsor: University of Michigan

Brief Summary

The study is intended to test whether a group-based Zoom behavioral treatment can help adults with chronic pain and opioid use disorder (OUD) learn effective strategies for reducing pain, disability and other problems that can come with these conditions (such as depression, anxiety, and difficulty managing emotions).

Detailed Description

Emotional Awareness and Expression Therapy (EAET) is a behavioral therapy that focuses on reducing chronic pain by helping people work on the effects of stress, trauma, and emotions that they have experienced in their lives. It is delivered in group sessions of 5-7 individuals by trained therapists who treat emotions or problems in relationships to reduce chronic pain. 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 to demonstrate the feasibility, acceptability, and preliminary efficacy of the proposed EAET intervention in adults with chronic pain and opioid use disorder.

Study Timeline

• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-10
• Status Verified: 2025-06
• Study Start: 2025-06-03
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-11
• Primary Completion: 2025-10
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Be able to read, write and speak English
• Have Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home
• Widespread pain and has opioid use disorder (OUD)

Exclusion Criteria

• Diagnosis of autoimmune disease, spinal cord injury, cancer.
• Currently receiving cognitive-behavioral therapy, EAET, or other psychological therapies for pain
• Open litigation regarding chronic pain in the past 1 year, as assessed in preliminary study screening.
• Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols.
• Pregnant or breastfeeding
• Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) at the post intervention timepoint.	Approximately day 70	The TAAS is a validated instrument for behavioral interventions. Although no validated cutoff scores exist for this measure, prior research has used an informal cutoff score at the midpoint of the total score (i.e., 35 out of a possible 70) as a measure of moderate acceptability. If the EAET intervention is ineffective, low acceptability may be an explanatory factor. - scores above the midpoint - 35 out of 70 - will denote moderate acceptability of the intervention
Feasibility: Session attendance	Approximately day 70
Feasibility: Combined completion of in-session and between-session practices	Approximately day 70

Secondary Outcome Measures

Name	Time	Method
Change in Brief Pain Inventory (BPI) pain intensity	Day 1 and up to day 160	The BPI pain intensity is a validated 4-item measure of pain intensity.; Change is measured from day 1 to day 70 AND day 1 to day 160
Change in Pain-related OUD Exacerbation Scale (PrOUD-ES)	Day 1 and up to day 160	Validated 4-item scale assessing self-reported degree of pain-related OUD symptom exacerbation.; Change is measured from day 1 to day 70 AND day 1 to day 160
Change in Opioid Craving Visual Analog Scale (OC-VAS)	Day 1 and up to day 160	The OC-VAS is a validated single-item assessment utilizing 0-100 scale reflecting degree of opioid craving.; Change is measured from day 1 to day 70 AND day 1 to day 160
Change in Current Opioid Misuse Measure-Brief (COMM-9)	Day 1 and up to day 160	The Comm-9 is a validated 9-item self-report measure of opioid misuse.; Change is measured from day 1 to day 70 AND day 1 to day 160

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States