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

NCT06865560 | Recruiting

• 1 other identifier: HUM00266504
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Pain; Opioid Use Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in Brief Pain Inventory (BPI) pain intensity

  Day 1 and up to day 160

• Change in Pain-related OUD Exacerbation Scale (PrOUD-ES)

  Day 1 and up to day 160

• Change in Opioid Craving Visual Analog Scale (OC-VAS)

  Day 1 and up to day 160

• Change in Current Opioid Misuse Measure-Brief (COMM-9)

  Day 1 and up to day 160

Study Arms (1)

Emotional Awareness and Expression Therapy (EAET)

EXPERIMENTAL

Adults with chronic pain and mild to moderate opioid use disorder (OUD).

Behavioral: Emotional Awareness and Expression Therapy (EAET)

Interventions

Emotional Awareness and Expression Therapy (EAET) BEHAVIORAL

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.

Emotional Awareness and Expression Therapy (EAET)

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• John Sturgeon, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Long

CONTACT

734-763-0108; josephlo@med.umich.edu

Sana Shaikh

CONTACT

734-763-5226; skazi@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 10, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)