Mechanisms of Psychosocial Treatments on Opioid Use in Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Change in Morphine Milligram Equivalent (MME) Average Daily Dose
研究概览
简要总结
This project will increase our understanding of the mechanisms underlying changes in opioid medication use associated with three psychosocial chronic pain (CP) treatments. These treatments are: (1) Cognitive Therapy (CT), (2) Mindfulness Meditation (MM), and (3) Behavioral Activation (BA). The sample will be adults with CP who are at risk of opioid misuse. The purpose of this study is to understand the specific ways these treatments work for reducing opioid use. In addition, the investigators are interested in examining moderators of treatment response. The findings will potentially inform the future streamlining of psychosocial treatments, as well as the development of algorithms for matching individuals with CP who are at risk for opioid misuse to the specific treatment most likely to efficiently optimize benefit.
详细描述
This study involves participating in eight videoconference group treatment sessions and telephone interviews over the course of approximately eight to nine months. All study procedures will take place over videoconferencing computer software, online, or by telephone. There are no in-person visits for the study. Participants wear an activity monitor for about two and a half months starting two weeks before treatment begins. They will also complete brief online surveys twice a day, once in the morning and once in the evening, for about two and a half months starting two weeks before treatment begins. These surveys will be completed on a computer, tablet, or smartphone.
Extended Assessments
During the study, participants would also complete four extended assessments with a research staff member. The first interview is completed before treatment begins, the second is completed after treatment ends, the third is completed three months after treatment ends, and the fourth and final is completed six months after treatment ends. The first two extended assessments (Pre- and Post-Treatment) are completed with a research staff member verbally over the telephone. The final two extended assessments (3-month and 6-month Follow-up) may be completed either with a research staff member verbally over the telephone or independently online.
Online Surveys
About two weeks before treatment starts, participants begin doing brief (~2-5 minutes) online surveys twice a day. The online surveys can be completed on a smartphone, tablet, laptop, or desktop computer. Automated notifications in the morning and in the evening remind the participant to complete the brief survey twice a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥18 years;
- •Meet criteria for having a chronic pain problem (≥3 months, with pain experienced on ≥50% of days in past 6 months);
- •Use of opioid medication in the past week;
- •Daily average opioid analgesic medication use in the past week of ≥20 MMEs;
- •Average intensity of chronic pain ≥3 on a 10-point scale for most days of the previous 3 months;
- •Able to read, speak, and understand English; and
- •Availability of a telephone, webcam, and microphone through computer or telephone, as well as daily internet access.
排除标准
- •Primary pain condition is headache;
- •Severe cognitive impairment;
- •Current alcohol or substance dependence;
- •Active malignancy (e.g., cancer not in remission), terminal illnesses, or serious medical conditions that may interfere with either study participation or with receiving potential treatment benefits (e.g., severe lupus);
- •Inability to walk (defined as unable to walk at least 50 yards), which would limit the ability of participants to benefit from the activation skills intervention;
- •Significant pain from a recent surgery or injury;
- •Pain condition for which surgery has been recommended and is planned;
- •Any planned surgery, procedure, hospitalization, treatment, or event that may conflict with or otherwise influence participation in the study;
- •Currently receiving or had received other psychosocial treatments for any pain condition;
- •Current or past participation in a research study with treatment components that may overlap, conflict, or affect those in the current study;
- •Current or history of diagnosis of primary psychotic or major thought disorder within the past 5 years;
- •Psychiatric hospitalization within the past 6 months;
- •Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months;
- •Any psychiatric or behavioral issues as noted in the medical record or disclosed/observed during self-report screening that would indicate participant may be inappropriate in a group setting; and
- •Presenting symptoms at the time of screening that would interfere with participation, specifically active suicidal or homicidal ideation with intent to harm oneself or others or active delusional or psychotic thinking.
研究组 & 干预措施
Cognitive Therapy (CT) Condition
Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.
干预措施: Cognitive Therapy (CT) (Behavioral)
Mindfulness Meditation (MM) Condition
Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events.
干预措施: Mindfulness Meditation (MM) (Behavioral)
Behavioral Activation (BA) Condition
Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
干预措施: Behavioral Activation (BA) (Behavioral)
结局指标
主要结局
Change in Morphine Milligram Equivalent (MME) Average Daily Dose
时间窗: Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks)
Respondents were asked to provide dosages and frequency of use of any opioid medications taken in the past seven days at the time of each telephone assessment. An average daily MME dose taken in the past week was computed for each assessment point, and a categorical variable was calculated to assess change throughout the trial (increase dose, decrease dose, no change).
次要结局
- Change in Physical Function(Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks))
- Change in Sleep Quality(Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks))
- Change in Pain Interference (Micro-level)(Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported)
- Change in Affect (Micro-level)(Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported)
- Change in Pain Interference (Macro-level)(Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks))
- Change in Affect (Macro-level)(Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks))
研究者
Mark Jensen
Professor, School of Medicine: Rehabilitation Medicine
University of Washington