Matching Adults to Treatments for Chronic Pain (MATCH) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 331
- 试验地点
- 6
- 主要终点
- Change in Average Daily Pain Intensity
研究概览
简要总结
Chronic pain is a prevalent, disabling problem affecting as many as 50% of men and 75% of women Veterans. Cognitive Behavioral Therapy (CBT) is the current gold standard treatment for chronic pain. However, while some individuals do respond to CBT, many individuals do not obtain meaningful benefit. As a result, the average response to CBT treatment in groups of individuals with chronic pain is only modest.
To address the need for effective treatments, the investigators have developed and adapted Complementary and Integrative Health (CIH) interventions such as Mindfulness-Based Cognitive Therapy (MBCT) and Hypnotic Cognitive Therapy (HYP-CT) for chronic pain management. Research shows these treatments are beneficial alternatives to CBT. However, as with CBT, response to these treatments varies, and the investigators' preliminary data suggests outcome variability is explained by a number of baseline patient factors. Research is now needed to advance knowledge regarding the pre-treatment patient factors (i.e., predictive markers) that moderate treatment outcome (i.e., patient factors that interact with treatment condition to predict outcome). The findings from this research will provide an empirical basis for developing patient-treatment matching algorithms to prospectively match a given individual to the evidence-based treatment most likely to be beneficial for them.
The investigators have initiated a program of research to identify the factors that predict response to psychosocial pain treatments, including HYP-CT, MBCT, and CBT. Preliminary findings suggest that predictive markers such as brain activity (e.g., alpha and beta power, as measured by EEG), and the traits of mindfulness, hypnotizability, and catastrophizing, will predict who benefits most from different treatments. For example, post hoc analyses show that those who are "well-matched" to HYP-CT, based on the identified baseline moderators, achieve twice the amount of pain reduction with treatment, compared to those who are not well- matched. To confirm these findings, prospective research is now needed. The findings from this study will provide a foundation upon which to develop an assessment battery to identify critical values on which to base algorithms for a priori matching of individual patients to different treatments. This has the potential to substantially boost the typically modest average effect sizes that are achieved when using a more traditional "one size fits all" approach.
详细描述
This study has a single overall aim: to identify patient predictive markers that determine who benefits most from two CIH treatments (hypnotic cognitive therapy [HYP-CT] and Mindfulness-Based Cognitive Therapy [MBCT]) and the current gold standard non-pharmacological treatment (CBT) vs. usual care (UC). This aim will be addressed in the context of a clinical trial in which participants with chronic pain will be randomized to one of the three active chronic pain treatments or UC. Based on findings from prior research, the investigators hypothesize that five primary predictive markers assessed at pre-treatment (alpha power, beta power, hypnotizability, nonreactivity [a mindfulness domain], and catastrophizing) will modify subsequent treatment-related changes in pain intensity following MBCT, HYP-CT, and CBT, relative to usual care.
The primary clinical endpoint is reduction (change) in average pain intensity from pre- to post-treatment; the post-treatment assessment point is the primary endpoint. Average pain intensity will be measured using a composite of up to 4 separate pain ratings assessed within a 1-week period at each study assessment window. Although there are up to four ratings, each from a different day in a 7-day window, that are used to compute post-treatment average pain severity score, these variables will be used to compute a single score representing average pain during the post-treatment period; therefore, there is only a single primary post-treatment end point.
The primary predictive markers are EEG-assessed alpha and beta power, researcher-measured hypnotizability, and self-reported-pain catastrophizing and non-reactivity mindfulness, all of which will be assessed at pre-treatment.
The five primary study hypotheses are as follows:
Hypotheses 1a, 1b, and 1c: Baseline alpha power will predict pre- to post-treatment change in pain intensity, such that, relative to UC, more alpha power predicts greater change (reduction) in pain intensity in response to HYP-CT (1a), and lower levels of alpha power predict greater pain intensity change (reduction) in response to both CBT (1b) and MBCT (1c).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •≥ 18 years old.
- •Having chronic pain, operationalized as average pain intensity in the last week rated as ≥ 3 on a 0-10 Numerical Rating Scale (NRS) and having pain on most days for 3 months or more.
- •Able to read, speak, and understand English.
- •Willingness to be randomized to condition and use videoconferencing with audio and video enabled.
- •Access to a private place with adequate internet reception to support participation in videoconferencing treatment sessions.
- •Not currently participating in another clinical trial or interventional study for chronic pain and willing to refrain from participation in any other clinical trial or interventional study for chronic pain during active participation in this study.
- •Willing, able, and committed to participate in an in-person EEG assessment.
- •Able to use a smart phone, tablet, or computer independently to access email and webpages or have someone available in their home who can help them with initial session set-up and then leave for the treatment sessions.
排除标准
- •The exclusion criteria for Veteran participants will be assessed via self-report and verified by VA medical records chart review. Eligibility for non-Veteran participants will be assessed by self-report (no medical records chart review). An individual who meets any of the following criteria at the time of screening will be excluded from participation in this study and will not be enrolled:
- •Active suicidal ideation/intent indicating significant risk.
- •Unstable medical or psychiatric condition (e.g., mania, psychotic symptoms) that would interfere with study participation.
- •Behavioral issues noted in the record or observed during the screening process that would interfere with appropriate or safe videoconferencing treatment session participation or study procedures.
- •Alcohol abuse (operationalized as scoring 15 or more if male or 13 or more if female on the Alcohol Use Disorders Identification Test), or any illicit drugs, all of which may impact EEG measures.
- •Severe cognitive impairment defined as two or more errors on the Six-Item Screener.
- •Having an EEG confounder (e.g., congenital or acquired skull defects, missing sections or holes in the skull, or plates, screws, or other implants within the skull or brain) that would interfere with reliable EEG data collection.
- •Active cancer treatment or primary pain is due to cancer.
研究组 & 干预措施
Cognitive Behavioral Therapy (CBT) condition
Participants randomized to this arm will be taught about the role of cognitions (particularly pain catastrophizing), pain beliefs (including perceived control), and maladaptive or unhelpful coping behaviors in chronic pain. This technique will help participants: (1) identify and change or restructure unhelpful or negative thinking about pain; (2) utilize positive coping strategies including positive coping self-statements; relaxation techniques; behavioral activation (including setting goals for activation), activity pacing and scheduling; and (3) cope with pain flare-ups.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
Hypnotic Cognitive Therapy (HYP-CT) condition
Participants randomized to this arm will be taught about the role of hypnosis to reduce pain, increase comfort and well-being, and to instill and reinforce healthy, adaptive cognitions. This technique will help participants to use their ability to enter a state of focused attention to then increase their acceptance of new adaptive ideas about pain provided both by (1) clinicians during sessions and on audio recordings, as well as (2) the participants themselves during self-hypnosis practice.
干预措施: Hypnotic Cognitive Therapy (HYP-CT) (Behavioral)
Mindfulness-Based Cognitive Therapy (MBCT) condition
Participants randomized to this arm will be taught about the role of MBCT in training the mind to respond more adaptively to pain. This technique will help participants: (1) apply the skills they learn not only to pain but also to the problems pain causes for them, including sleep disturbance, depressed mood, stress, and other problems; (2) build on their strengths and their innate ability to focus their attention at will, and to use this ability to mindfully perceive experience in a non-judgmental, non-reactive way; and (3) notice their moment-to-moment experience and to shift their relationship to this experience. With enhanced mindful awareness comes the opportunity to then mindfully choose how to respond to the pain in a way that reduces stress and is most helpful or adaptive.
干预措施: Mindfulness-Based Cognitive Therapy (MBCT) (Behavioral)
Usual Care (UC) Control Group condition
In the Usual Care condition, participants will not participate in a study treatment, but rather they will continue with their usual care for chronic pain and will complete the seven study assessment sets. At the end of the study, after the final 6-month follow-up assessment period, participants will be given the opportunity to receive any one of the three treatments that they would like as part of an open label phase of the study UNLESS participants have developed new problems that would make them ineligible.
结局指标
主要结局
Change in Average Daily Pain Intensity
时间窗: Assessed online up to 4 times within a 7-day period at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.
Change in pain intensity will be measured using a 0-10 numerical rating scale (NRS) of average pain in the past 24 hours, up to 4 times within a 7-day period. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity.
次要结局
- Change in Anxiety(Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.)
- Change in Pain Interference(Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.)
- Change in Social Role Participation(Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.)
- Change in General Health(Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.)
- Change in Medication Use(Assessed online at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.)
- Change in Well-being(Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.)
- Change in Cannabis Use(Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.)
- Change in Depression(Assessed online at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.)
- Change in Sleep Quality(Assessed online at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.)
- Change in Fatigue(Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.)
- Global Impressions of Change(Assessed online at post-tx (8-week).)
- Change in Cognition(Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.)
- Change in Fear Avoidance Beliefs(Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.)
- Change in Pain Intensity without Medications(Assessed online at pre-tx, 2-week, 4-week, 6-week, post-tx (8-week), and at 3- and 6-month follow-ups.)
- Change in PTSD Symptoms(Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.)
- Change in Alcohol Use(Assessed online at pre-tx, post-tx (8-week), and at 6-month follow-up.)
- Global Assessment of Treatment Satisfaction(Assessed online at post-tx (8-week).)
研究者
Mark Jensen
Professor: Rehabilitation Medicine
University of Washington