Chronic Pain, Opioid Use Disorder
Conditions
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.
Interventions
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.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn Sturgeon, PhD
University of Michigan
Outcome results
None listed