Clinical trial NCT06865560: Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder
Official title: Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder - A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Opioid Use Disorder
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) at the post intervention timepoint.
timeFrame: Approximately day 70
measure: Feasibility: Session attendance
timeFrame: Approximately day 70
measure: Feasibility: Combined completion of in-session and between-session practices
timeFrame: Approximately day 70
Secondary outcomes:
measure: Change in Brief Pain Inventory (BPI) pain intensity
timeFrame: Day 1 and up to day 160
measure: Change in Pain-related OUD Exacerbation Scale (PrOUD-ES)
timeFrame: Day 1 and up to day 160
measure: Change in Opioid Craving Visual Analog Scale (OC-VAS)
timeFrame: Day 1 and up to day 160
measure: Change in Current Opioid Misuse Measure-Brief (COMM-9)
timeFrame: Day 1 and up to day 160
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: John Sturgeon, PhD
role: PRINCIPAL_INVESTIGATOR
References: