Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder - A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) at the post intervention timepoint.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Emotional Awareness and Expression Therapy (EAET)
Adults with chronic pain and mild to moderate opioid use disorder (OUD).
Intervention: Emotional Awareness and Expression Therapy (EAET) (Behavioral)
Outcomes
Primary Outcomes
Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) at the post intervention timepoint.
Time Frame: 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
Time Frame: Approximately day 70
Feasibility: Combined completion of in-session and between-session practices
Time Frame: Approximately day 70
Secondary Outcomes
- 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)
Investigators
John Sturgeon
Clinical Assistant Professor of Anesthesiology
University of Michigan