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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emotional Awareness and Expression Therapy (EAET) | Experimental | Adults with chronic pain and mild to moderate opioid use disorder (OUD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brief Pain Inventory (BPI) pain intensity | 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 | Day 1 and up to day 160 |
| Change in Pain-related OUD Exacerbation Scale (PrOUD-ES) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Sturgeon, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
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 |
| Day 1 and up to day 160 |
| Change in Opioid Craving Visual Analog Scale (OC-VAS) | 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 | Day 1 and up to day 160 |
| Change in Current Opioid Misuse Measure-Brief (COMM-9) | 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 | Day 1 and up to day 160 |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |