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.
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
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
Parallel
Empowering Pain Psychology Access and Collaboration (EPPAC)
BehavioralEPPAC is a brief, psychologist-led engagement strategy embedded within a standard pain psychology evaluation. It combines motivational interviewing and shared decision-making, structured pain education, a patient decision aid, two decision points, balanced discussion of CBT and EAET (presented to participants as PERT), and next-step planning to support informed engagement in pain psychology care.
Usual Care Pain Psychology Evaluation
BehavioralUsual care consists of the clinic's standard pain psychology evaluation and usual discussion of clinical recommendations and treatment options. It does not include the EPPAC-specific decision aid, standardized EPPAC pain education, exact Decision Point 1 question, or EPPAC next-steps probe. CBT and EAET, presented to participants as PERT, are downstream clinical treatment options available in both study arms.
Percentage of participant and provider Acceptability of Intervention Measure (AIM) responses with a mean score of 4 or greater
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
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
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
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.
Percentage of randomized participants initiating pain psychology treatment by 12 weeks
Treatment initiation is defined as attendance at least one cognitive behavioral therapy (CBT) or emotional awareness and expression therapy (EAET; presented to participants as PERT) treatment session documented in the electronic medical record (EMR) within 12 weeks. The denominator is all randomized participants, consistent with the intent-to-treat approach.
Total number of treatment sessions attended (out of 8 sessions)
Total number of treatment sessions attended will be determined using the EMR.
Participant's choice of treatment
Participant treatment decision at the end of the evaluation workflow, categorized as cognitive behavioral therapy (CBT), emotional awareness and expression therapy (EAET; presented to participants as PERT), or no treatment selected, assessed by randomized arm.
Percentage of treatment initiators who discontinue treatment before completing 6 sessions
Among participants who initiate pain psychology treatment by attending at least one CBT or EAET/PERT session, treatment dropout is defined as discontinuing before completion of 6 treatment sessions within the 12-week treatment-engagement period. Treatment attendance will be determined using the EMR.
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Johns Hopkins University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
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