Comparative Mechanisms (Moderators, Mediators) of Psychosocial Treatments of Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 408
- 试验地点
- 4
- 主要终点
- Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a
研究概览
简要总结
Chronic musculoskeletal pain (CP) is a major public health concern. Psychosocial treatments have been shown to be efficacious when compared to largely inert control conditions, but they are characterized by modest effects on primary outcomes. One strategy to boost efficacy is to increase our understanding of treatment mediators. Studies of mediators that directly compare different treatments with each other are needed to determine which mediators are treatment-specific, which are shared across treatments, and which contribute the most to clinical outcomes. Another strategy is to identify the patient characteristics that moderate treatment responses. Research is needed that is guided by theoretical models and that tests moderators across multiple treatments. Identifying subgroups of patients more likely to respond to one or another treatment can advance precision medicine by informing a priori patient-treatment matches that can optimize treatment effects. To accomplish these goals, the authors will conduct a randomized clinical trial to compare the mediators and moderators of the clinical effects of Cognitive-Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Emotional Awareness and Expression Therapy (EAET) on adults with chronic spinal (axial) pain. Following baseline assessment of outcome variables as well as potential mediators and moderators, 460 participants will be randomized to CBT, ACT, EAET, or treatment-as-usual control (TAU). The three treatments will be conducted as individual therapy provided weekly for 8 weeks via telehealth. The researchers will conduct weekly assessments of both potential mediators and outcomes, as well as post-treatment and 6-month follow-up assessments. The goal of the study is to identify the most powerful treatment mechanisms - specific and shared -- and reveal for whom the mediator-outcome pathways are strongest.This project can increase the effects of our psychosocial chronic pain treatments by identifying the most effective treatment mechanisms and by informing patient-treatment matches that can optimize treatment effects.
详细描述
Chronic musculoskeletal pain (CP) is a major public health concern. A number of psychosocial treatments have emerged in recent decades to help address this problem. These interventions have been shown to be efficacious when compared to largely inert control conditions; however, recent meta-analyses indicate that most of these treatments are characterized by modest effects on primary outcomes. This is a critical shortcoming of these otherwise promising approaches. Rather than attempting to boost efficacy only by developing new and hopefully more powerful interventions, we can also look within our already proven treatments for ways to enhance the magnitude of treatment effects. One strategy is to increase our understanding of treatment mediators. Studies of mediators that directly compare different treatments with each other are needed to determine which mediators are treatment-specific, which are shared across treatments, and which contribute the most to clinical outcomes. The findings from such research could be used to inform adaptations to existing treatment that enhance their benefits. A second strategy for increasing the beneficial effects of existing treatments is to identify the patient characteristics that moderate treatment responses. Research is needed that is guided by theoretical models and that tests moderators across multiple treatments. Identifying subgroups of patients more likely to respond to one or another treatment can advance precision medicine by informing a priori patient-treatment matches that can optimize treatment effects. To accomplish these goals, we will conduct a randomized clinical trial to compare the mediators and moderators of the clinical effects of Cognitive-Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Emotional Awareness and Expression Therapy (EAET) on adults with chronic spinal (axial) pain. Following baseline assessment of outcome variables as well as potential mediators and moderators we will randomize 460 participants to CBT, ACT, EAET, or treatment-as-usual control (TAU). The three treatments will be conducted as individual therapy provided weekly for 8 weeks via telehealth. We will conduct weekly assessments of both potential mediators and outcomes, as well as post-treatment and 6-month follow-up assessments. In addition to comparing the three treatments to each other (and TAU) for overall efficacy, we focus on two specific aims: Aim 1 is to identify mediators that are specific to treatments and those that are shared across treatments. Aim 2 is to identify baseline moderators of specific treatments and general predictors across treatments. This project can increase the effects of our psychosocial chronic pain treatments by identifying the most powerful treatment mechanisms - specific and shared -- and revealing for whom the mediator-outcome pathways are strongest. Via increased understanding of mediator and moderators, more effective pain treatment approaches can be developed, tested, and implemented.
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)
盲法说明
Masking of research staff and participants until baseline assessment is completed. Masking of research staff who interact with patients for outcome assessments.
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
- •Back/neck is primary pain location (e.g., back/neck pain greater than leg pain)
- •Pain for at least 3 months and experienced 4 or more days/week for the past 6 months
- •Pain intensity last week is >= 3 (0 to 10 rating scale)
- •Pain interference last week is >= 3 (0 to 10 rating scale)
- •At least age 18
- •Lives in United States
- •Fluent in English
- •Has personal computer/tablet and internet access
- •Able to attend weekly sessions
- •Willing to be randomized
- •Seeking to improve their pain-related status via a psychological therapy
排除标准
- •Past 2 years (treated for or having experienced):
- •Complex regional pain syndrome
- •Epilepsy/seizure disorder
- •Autoimmune disease
- •Liver disease
- •Heart disease
- •Substance dependence or use disorder
- •Schizophrenia or other psychotic disorder
- •Bipolar disorder
- •Obsessive-compulsive disorder
- •Borderline personality disorder
- •Suicide attempt or suicide intention or impulse
- •Major medical procedure scheduled within next 9 months
- •Applied for/ litigating for pain-related disability/worker's compensation (past year).
- •Major life event/stressor in past 6 months
- •Cognitive impairment (screener score <=4)
研究组 & 干预措施
Emotional Awareness and Expression Therapy
8-session, individual, Emotional Awareness and Expression Therapy delivered remotely by skilled EAET
干预措施: Emotional Awareness and Expression Therapy (Behavioral)
Cognitive Behavioral Therapy
8-session, individual, Cognitive Behavioral Therapy delivered remotely by skilled CBT therapists
干预措施: Cognitive Behavioral Therapy (Behavioral)
Acceptance and Commitment Therapy
8-session, individual, Acceptance and Commitment Therapy delivered remotely by skilled ACT therapists
干预措施: Acceptance and Commitment Therapy (Behavioral)
结局指标
主要结局
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference - Short Form 8a
时间窗: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
8-item measure of pain interference over past week (range1 to 5; higher scores = more pain interference)
Brief Pain Inventory (BPI) - Pain Severity
时间窗: Baseline to post-treatment and 6-month follow-up, and weekly during treatment
4-item measure of pain severity over past week (range 0 to 10; higher scores = worse pain severity)
次要结局
- Patient Global Impression of Change(Weekly during treatment to post-treatment and 6-month follow-up)
- Positive and Negative Affect Schedule (PANAS) - Positive Affect - Short Form(Baseline to post-treatment and 6-month follow-up, and weekly during treatment)
- Posttraumatic Stress Disorder Checklist (PCL) - Short Form(Baseline to post-treatment and 6-month follow-up, and weekly during treatment)
- Pain Stages of Change Questionnaire (PSOCQ): Preparation and action(Baseline to post-treatment and 6-month follow-up, and weekly during treatment)
- Patient Health Questionnaire - Depression(Baseline to post-treatment and 6-month follow-up, and weekly during treatment)
- Patient-Reported Outcome Measurement Information System (PROMIS) - Sleep Disturbance - Short Form(Baseline to post-treatment and 6-month follow-up, and weekly during treatment)
- Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function - Short Form 10a(Baseline to post-treatment and 6-month follow-up, and weekly during treatment)
- Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anxiety - Short Form(Baseline to post-treatment and 6-month follow-up, and weekly during treatment)
- Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Depression - Short Form(Baseline to post-treatment and 6-month follow-up, and weekly during treatment)
- Employment(Baseline to post-treatment and 6-month follow-up)
- Levels of Emotional Awareness Scale (LEAS) - Forms A and B(Baseline)
- Inventory of Interpersonal Problems (IIP)(Baseline to post-treatment and 6-month follow-up)
- The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool - Part II(Baseline to post-treatment and 6-month follow-up)
- Patient-Reported Outcome Measurement Information System (PROMIS) - Fatigue - Short Form(Baseline to post-treatment and 6-month follow-up, and weekly during treatment)
- Patient-Reported Outcome Measurement Information System (PROMIS) - Emotional Distress - Anger - Short Form 5a(Baseline to post-treatment and 6-month follow-up, and weekly during treatment)
- Opioid Use(Baseline to post-treatment and 6-month follow-up, and weekly during treatment)
- Post-Treatment Satisfaction Questionnaire(Post-Treatment to 6-Month Follow-Up)
- Other Pain Treatments and Health Care Use(Baseline to post-treatment and 6-month follow-up)
- American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria - 2011(Baseline to post-treatment and 6-month follow-up)
- Posttraumatic Stress Disorder Checklist (PCL)(Baseline to post-treatment and 6-month follow-up)
- Psychological Flexibility Scale (PSYFlex)(Baseline to post-treatment and 6-month follow-up)
