The University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT06865560
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: Approximately day 70
Time frame: Approximately day 70
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
University of Michigan
Other
Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder - A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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