Treating Pain With Acceptance and Commitment Therapy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Primary study outcome will be the Success Scale of the Chronic Pain Values Inventory.
研究概览
简要总结
The long-term goal is to define best practices for diminishing the risk of high opioid doses used to treat chronic non-cancer pain (CNCP) patients while optimizing pain outcomes and functional levels of activity, emotional functioning, and quality of life. The short-term goal is to assess the feasibility of multiple Clinical and Translational Research Award (CTSA) sites working together to perform and study the effects of a cognitive behavioral therapy intervention in a future randomized controlled trial (RCT) among CNCP patients in rural primary care practices in each CTSA state.
详细描述
The long-term goal is to define best practices for diminishing the risk of high opioid doses used to treat chronic non-cancer pain (CNCP) patients while optimizing pain outcomes and functional levels of activity, emotional functioning, and quality of life. The short-term goal is to assess the feasibility of multiple Clinical and Translational Research Award (CTSA) sites working together to perform and study the effects of a cognitive behavioral therapy intervention in a future randomized controlled trial (RCT) among CNCP patients in rural primary care practices in each CTSA state.
The current feasibility study uses a multi-site, pragmatic, community-based, mixed methods design to assess the feasibility of multiple CTSA locations working together to administer the evidence-based intervention, Acceptance and Commitment Therapy (ACT), to reduce harmful opioid use among CNCP patients. This mixed methods study will have a quantitative arm and a qualitative arm. Following this feasibility study, the team will use the resulting preliminary data to apply for a larger grant to implement a larger multi-site RCT at the same sites.
The specific aims of this feasibility study are:
- To conduct a multi-site, mixed methods study to demonstrate the feasibility of performing a future pragmatic RCT on the effectiveness of treating CNCP with Acceptance and Commitment Therapy (ACT), delivered in rural primary healthcare practices, with the goal of decreasing chronic, harmful opioid use among rural populations.
- To generate preliminary data that will be used to apply for a larger multi-site RCT study that would test the effectiveness of ACT in the same population of rural pain patients.
The feasibility study hypothesis is that the study team can demonstrate the ability for multiple CTSA sites to work together on a small research project in rural primary care practices, among rural patients with chronic non-cancer pain on long-term opioid therapy. The team will show that it is feasible to implement the intervention ACT in a future larger RCT study, which would test its effectiveness at reducing or eliminating opioid use while managing chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (21-65 years of age).
- •Has a diagnosis of CNCP (> 3 months). We will limit the diagnostic inclusion criteria to the most common pain diagnoses (excluding headache): low back, multi-site/full body (e.g., fibromyalgia, and various kinds of arthritis), neck, lower extremity, and abdomen.
- •Being prescribed chronic opioid medications for the pain.
- •Mentally and physically able to participate in data collection (namely, completing an extensive survey at three points in time, attending 8 one-hour therapy sessions, and participating in an interview by the research staff).
排除标准
- •Children under the age of 21 will be excluded from participating because this study is examining ACT in adults with CNCP. Pregnant women will be excluded because their use of opioids presents a special therapeutic circumstance out of the scope of this study. People who are not fluent in English will be excluded because this is a small feasibility study and we do not have the resources to conduct the intervention or collect data in other languages.
研究组 & 干预措施
Acceptance and Commitment Therapy
The intervention consists of eight individual (one-on-one) acceptance and commitment therapy sessions approximately one week apart over a 12-week period.
干预措施: Acceptance and Commitment Therapy (Behavioral)
结局指标
主要结局
Primary study outcome will be the Success Scale of the Chronic Pain Values Inventory.
时间窗: One year
Primary study outcome will be the Success Scale of the Chronic Pain Values Inventory (CPVI). Based on an in-progress meta-analysis of unidisciplinary Acceptance and Commitment Therapy for chronic pain, we expect a post-treatment effect size of d = .80 (95% CI: .41 - 1.20). Construct: The CPVI has 12 items that measure, "which values are important to an individual and to assess the degree of success they are having in following their values" and "has supported its use in a contextual analysis of pain and as part of a treatment for chronic pain." Scale ranges: 0 to 5. First sore is mean success rating; second score is mean discrepancy rating. Outcome measures: "Low success in living in accordance to an important value is presumed to entail greater suffering than low success in living in accordance to a value that is relatively unimportant."
次要结局
- The secondary study outcome will be the Pain Interference Scale of the Brief Pain Inventory.(One year)
研究者
Robert L Rhyne
Professor & Vice Chair of Research
University of New Mexico