Emotional Awareness and Expression Therapy for Chronic Pain and Opioid Use Disorder - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) at the post intervention timepoint.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Emotional Awareness and Expression Therapy (EAET)
Adults with chronic pain and mild to moderate opioid use disorder (OUD).
干预措施: Emotional Awareness and Expression Therapy (EAET) (Behavioral)
结局指标
主要结局
Mean scores on the Treatment Acceptability and Adherence Scale (TAAS) at the post intervention timepoint.
时间窗: 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
时间窗: Approximately day 70
Feasibility: Combined completion of in-session and between-session practices
时间窗: Approximately day 70
次要结局
- 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)
研究者
John Sturgeon
Clinical Assistant Professor of Anesthesiology
University of Michigan