跳至主要内容
临床试验/NCT07843706
NCT07843706尚未招募不适用

Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain: a Pilot Randomized Controlled Trial

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Percentage of participant and provider Acceptability of Intervention Measure (AIM) responses with a mean score of 4 or greater

研究概览

简要总结

Chronic low back pain (cLBP) is a leading cause of disability, with socioeconomically disadvantaged populations experiencing worse outcomes and lower rates of treatment initiation for evidence-based pain psychology services. Participant engagement strategies such as shared decision-making (SDM) and motivational interviewing (MI) have shown promise in improving treatment uptake, but no study has examined whether integrating these approaches into a pain psychology evaluation can improve engagement among socioeconomically disadvantaged participants or offered participants a structured choice between cognitive behavioral therapy (CBT) and emotional awareness and expression therapy (EAET), presented to participants as Pain and Emotion Reprocessing Therapy (PERT). The Empowering Pain Psychology Access and Collaboration (EPPAC) intervention, a brief, psychologist-led engagement strategy combining SDM and MI within a standard pain psychology evaluation, was developed to address this gap.

详细描述

Chronic low back pain (cLBP) is among the leading causes of disability worldwide, affecting approximately 12.8 million adults in the United States. Individuals with low socioeconomic status (SES) are disproportionately affected, with roughly twice the rate of developing cLBP compared with higher-SES populations. The investigator's prior work has shown that socioeconomically disadvantaged adults with cLBP report worse pain-related outcomes than more advantaged counterparts, underscoring the need for effective and accessible treatments in this population.

Clinical practice guidelines recommend nonpharmacological approaches, including pain psychology, as first-line treatments for cLBP. Among the most established pain psychology treatments is cognitive behavioral therapy (CBT), which targets maladaptive patterns of thinking and behavior that contribute to pain, disability, and distress. A growing evidence base also supports emotional awareness and expression therapy (EAET), presented to participants in REACH as Pain and Emotion Reprocessing Therapy (PERT). EAET is grounded in contemporary pain neuroscience and addresses emotional experiences, stress, and interpersonal processes that may contribute to chronic pain.

Despite the availability of these treatments, a substantial proportion of participants referred for pain psychology do not initiate treatment, with reported initiation rates ranging from 24% to 73%. Preliminary findings from the OPTIMIZE trial, a pragmatic comparative effectiveness study of nonpharmacological treatments for cLBP conducted across three US health systems, indicate that only 59% of participants randomized to CBT initiated treatment, with socioeconomic factors such as neighborhood deprivation emerging as significant predictors of non-initiation. These findings suggest that socioeconomically disadvantaged participants face distinct barriers to engaging with psychological treatments for pain, and that simply offering effective treatments is insufficient if participants do not start treatments.

Participant engagement strategies have shown promise in improving treatment uptake. Shared decision-making (SDM) supports informed choices by presenting treatment options alongside benefits and trade-offs in a structured, collaborative conversation. Motivational interviewing (MI) supports motivation by exploring ambivalence and strengthening commitment in a non-confrontational manner. A prior trial by the investigator's team demonstrated that a single-session MI intervention delivered during a clinical encounter increased participation in physical therapy, reduced disability, and improved health outcomes among adults undergoing surgery for degenerative lumbar spinal stenosis. More recently, the Equity Using Interventions for Pain and Depression (EQUIPD) pilot trial demonstrated that coaching paired with a decision aid to facilitate SDM about nonpharmacological pain treatments was feasible and showed improvements in shared decision-making, participant engagement, and therapeutic alliance among Black participants with chronic musculoskeletal pain. However, no study has examined whether integrating SDM and MI into a pain psychology evaluation can improve treatment initiation among socioeconomically disadvantaged participants, nor has any study offered participants a structured choice between CBT and EAET.

To address this gap, the Empowering Pain Psychology Access and Collaboration (EPPAC) intervention, a brief, psychologist-led engagement strategy designed to be embedded within a standard pain psychology evaluation, was developed. EPPAC combines MI techniques with a structured SDM framework to help participants understand how psychology relates to pain, explore whether treatment fits the participant's situation, and choose between CBT and EAET based on the participant's values and preferences. In participant-facing REACH materials, EAET is presented as Pain and Emotion Reprocessing Therapy (PERT). The purpose of this study is to evaluate the feasibility, acceptability, and preliminary effectiveness of EPPAC compared with usual care among Medicaid-insured adults with cLBP in a pilot randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

Follow-up outcomes are primarily participant-reported and completed directly through REDCap. Study staff may administer or assist with follow-up assessments by telephone when needed. Because staff involved in participant follow-up may be aware of treatment assignment, the study is open label, and no outcome assessor is designated as masked.

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Chronic low back pain lasting at least 3 months and present at least half the days in the past 6 months, with an Oswestry Disability Index (ODI) score of at least 24%
  • •Medicaid insurance as primary or secondary coverage documented in the medical record, including eligible dual Medicare-Medicaid coverage
  • •Able to complete study procedures in English
  • •Able to participate in the telehealth clinical workflow and complete online questionnaires, with telephone assistance when needed

排除标准

  • •Specific spinal pathology or medical condition requiring immediate intervention that makes study participation inappropriate
  • •Currently receiving psychological treatment specifically for chronic pain at the time of screening
  • •Lumbar spine surgery within the past 6 months
  • •Severe psychiatric, cognitive, or substance-related condition that interferes with safe participation or meaningful consent
  • •Enrollment in another interventional study for chronic low back pain that could confound study outcomes
  • •Current cancer other than skin cancer

研究组 & 干预措施

Empowering Pain Psychology Access and Collaboration (EPPAC)

Experimental

Participants receive the standard pain psychology evaluation followed by the structured EPPAC engagement and shared decision-making process during the same scheduled telehealth appointment. EPPAC helps participants decide whether pain psychology fits their treatment plan and, if treatment is selected, choose between cognitive behavioral therapy (CBT) and emotional awareness and expression therapy (EAET), presented to participants as Pain and Emotion Reprocessing Therapy (PERT). Subsequent CBT or EAET/PERT treatment is routine clinical care and is available in both study arms.

干预措施: Empowering Pain Psychology Access and Collaboration (EPPAC) (Behavioral)

Usual Care

Active Comparator

Participants receive the standard pain psychology evaluation and the clinic's usual discussion of treatment recommendations and available options, without the EPPAC-specific structured elements. CBT and EAET, presented to participants as PERT, remain available as clinically appropriate. Subsequent treatment is routine clinical care.

干预措施: Usual Care Pain Psychology Evaluation (Behavioral)

结局指标

主要结局

Percentage of participant and provider Acceptability of Intervention Measure (AIM) responses with a mean score of 4 or greater

时间窗: Immediately following the initial evaluation appointment

The AIM is a 4-item measure scored on a 5-point Likert scale (1 = Completely disagree to 5 = Completely agree). A respondent-level mean score is calculated across the four items, with higher scores indicating greater acceptability. Participant and provider responses will be summarized separately. For this pilot, the prespecified study-defined acceptability benchmark is at least 70% of participant responses and at least 70% of provider responses with a mean AIM score of 4 or greater.

Percentage of participant and provider Intervention Appropriateness Measure (IAM) responses with a mean score of 4 or greater

时间窗: Immediately following the initial evaluation appointment

The IAM is a 4-item measure scored on a 5-point Likert scale (1 = Completely disagree to 5 = Completely agree). A respondent-level mean score is calculated across the four items, with higher scores indicating greater perceived appropriateness. The percentage of responses with a mean score of 4 or greater will be reported separately for participants and providers and interpreted descriptively; no pass/fail appropriateness threshold is prespecified.

Proportion of EPPAC evaluations in which the required core EPPAC components were delivered as intended

时间窗: Immediately following the initial evaluation appointment

Fidelity will be assessed using structured provider-completed documentation in Epic indicating completion of the core EPPAC stages and intervention components. For this pilot, the prespecified study-defined feasibility benchmark is delivery of the required EPPAC components in at least 70% of EPPAC evaluation visits. Sessions will not be recorded or independently coded for fidelity.

Percentage of participant and provider Feasibility of Intervention Measure (FIM) responses with a mean score of 4 or greater

时间窗: Immediately following the initial evaluation appointment

The FIM is a 4-item measure scored on a 5-point Likert scale (1 = Completely disagree to 5 = Completely agree). A respondent-level mean score is calculated across the four items, with higher scores indicating greater perceived feasibility. The percentage of responses with a mean score of 4 or greater will be reported separately for participants and providers and interpreted descriptively; the study's prespecified feasibility benchmark is based on EPPAC delivery fidelity rather than an FIM cutoff.

次要结局

  • Percentage of randomized participants initiating pain psychology treatment by 12 weeks(12 weeks)
  • Total number of treatment sessions attended (out of 8 sessions)(12 weeks)
  • Participant's choice of treatment(Immediately following the initial evaluation appointment)
  • Percentage of treatment initiators who discontinue treatment before completing 6 sessions(12 weeks)
  • The frequency of participants who stated a preference for Cognitive Behavioral Therapy (CBT), Emotional Awareness and Expression Therapy (EAET; presented to participants as PERT), or were unsure.(Immediately following the initial evaluation appointment)
  • Percentage of participants with decisional conflict on the Sure of myself, Understand information, Risk-benefit ratio, Encouragement (SURE) test(Immediately following the initial evaluation appointment)
  • CollaboRATE shared decision-making score(Immediately following the initial evaluation appointment)
  • Participant openness to future engagement, assessed by arm and by treatment initiation status.(Immediately following the initial evaluation appointment)
  • Pain Self-Efficacy Questionnaire-Two-Item Short Form (PSEQ-2)(Baseline, 12 weeks, and 24 weeks)
  • Oswestry Disability Index (ODI)(Screening, 12 weeks, and 24 weeks)
  • Patient-Reported Outcome Measurement Information System (PROMIS-29+2 Profile v2.1 (PROPr))(Baseline, 12 weeks, and 24 weeks)
  • University of Washington Concerns About Pain Scale (UW-CAP) 6-item short form))(Baseline, 12 weeks, and 24 weeks)
  • Patient Global Impression of Change (PGIC)(12 weeks and 24 weeks)
  • The STarT Back Screening Tool (SBST)(Baseline)

研究者

发起方
Johns Hopkins University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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