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

Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder - A Pilot Study

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Opioid Use Disorder
• Intervention / Treatment: Behavioral: Emotional Awareness and Expression Therapy (EAET)

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sana Shaikh; Phone Number: 734-763-5226; Email: skazi@med.umich.edu
• Study Contact Backup: Name: Joseph Long; Phone Number: 734-763-0108; Email: josephlo@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • The University of Michigan
      • Contact: Sana Shaikh; Phone Number: 734-763-5226; Email: skazi@med.umich.edu
      • Principal Investigator: John Sturgeon, PhD
      • Contact: Joseph Long; Phone Number: 734-763-0108; Email: josephlo@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Emotional Awareness and Expression Therapy (EAET); Adults with chronic pain and mild to moderate opioid use disorder (OUD).

Behavioral: Emotional Awareness and Expression Therapy (EAET); A validated, 8-week, group-based telehealth-based behavioral intervention for chronic pain. Session content will include pain neuroscience education, emotion-focused expressive writing, in-vivo emotional expression practices, self-compassion and forgiveness exercises, and assertive communication strategies. Participants will also be provided handouts and pre-recorded guided imagery and cognitive exercises that they can use to facilitate between-session practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) at the post intervention timepoint.	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	Approximately day 70
Feasibility: Session attendance		Approximately day 70
Feasibility: Combined completion of in-session and between-session practices		Approximately day 70

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brief Pain Inventory (BPI) pain intensity	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	Day 1 and up to day 160
Change in Pain-related OUD Exacerbation Scale (PrOUD-ES)	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	Day 1 and up to day 160
Change in Opioid Craving Visual Analog Scale (OC-VAS)	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	Day 1 and up to day 160
Change in Current Opioid Misuse Measure-Brief (COMM-9)	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	Day 1 and up to day 160

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: John Sturgeon, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Opioid-Related Disorders; Chronic Pain
• Other Study ID Numbers: HUM00266504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No