[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657921":3},{"organization":4,"outcomesModule":7,"designInfo":71,"detailedDescription":79,"studyPopulation":70,"armGroups":80,"interventions":93,"overallOfficials":102,"centralContacts":106,"locations":115,"responsibleParty":136,"collaborators":138,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":70,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":70,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":172,"whyStopped":70,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":70},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"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.","Immediately following the initial evaluation appointment",{"measure":14,"description":15,"timeFrame":12},"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\u002Ffail appropriateness threshold is prespecified.",{"measure":17,"description":18,"timeFrame":12},"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.",{"measure":20,"description":21,"timeFrame":12},"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.",[23,27,30,33,36,39,42,45,48,52,56,59,62,66],{"measure":24,"description":25,"timeFrame":26},"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.","12 weeks",{"measure":28,"description":29,"timeFrame":26},"Total number of treatment sessions attended (out of 8 sessions)","Total number of treatment sessions attended will be determined using the EMR.",{"measure":31,"description":32,"timeFrame":12},"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.",{"measure":34,"description":35,"timeFrame":26},"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\u002FPERT 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.",{"measure":37,"description":38,"timeFrame":12},"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.","Participants' stated treatment preference will be assessed using a single item completed prior to completion of the decisional conflict measure.",{"measure":40,"description":41,"timeFrame":12},"Percentage of participants with decisional conflict on the Sure of myself, Understand information, Risk-benefit ratio, Encouragement (SURE) test","The SURE test is a 4-item binary screening measure derived from the Decisional Conflict Scale. Each item is scored 0 or 1, yielding a total score from 0 to 4. A score of 4 (better) indicates no decisional conflict; scores of 0 to 3 indicate decisional conflict.",{"measure":43,"description":44,"timeFrame":12},"CollaboRATE shared decision-making score","CollaboRATE is a 3-item participant-reported measure of the shared decision-making process. Each item is scored from 0 (no effort was made) to 4 (every effort was made), yielding a total score from 0 to 12, with higher scores indicating greater shared decision-making. A top score is defined as the highest response on all three items and may also be reported as the proportion of participants achieving a top score.",{"measure":46,"description":47,"timeFrame":12},"Participant openness to future engagement, assessed by arm and by treatment initiation status.","Participant openness to future engagement, assessed with an investigator-developed single item: \"If my situation changes in the future, I would consider working with a psychologist for my pain.\" This item is rated on a 5-point agreement scale with higher scores indicating greater levels of openness to future engagement.",{"measure":49,"description":50,"timeFrame":51},"Pain Self-Efficacy Questionnaire-Two-Item Short Form (PSEQ-2)","The Pain Self-Efficacy Questionnaire 2-item short form (PSEQ-2) assesses confidence in performing activities despite pain. Total scores range from 0 to 12, with higher scores indicating greater pain self-efficacy.","Baseline, 12 weeks, and 24 weeks",{"measure":53,"description":54,"timeFrame":55},"Oswestry Disability Index (ODI)","The Oswestry Disability Index is a 10-item measure of low back pain-related disability across pain intensity and daily activities. Each item is scored from 0 to 5. The item scores are summed and converted to a percentage disability score ranging from 0% to 100%, with higher scores indicating greater disability.","Screening, 12 weeks, and 24 weeks",{"measure":57,"description":58,"timeFrame":51},"Patient-Reported Outcome Measurement Information System (PROMIS-29+2 Profile v2.1 (PROPr))","The Patient-Reported Outcome Measurement Information System (PROMIS-29+2 Profile v2.1 \\[PROPr\\]) assesses 8 domains: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Cognitive Function-Abilities, in addition to a Pain Intensity item. The multi-item domains use 5-category response scales and are converted to standardized T-scores (mean = 50, standard deviation = 10); the Pain Intensity item is scored from 0 to 10. Higher T-scores indicate more of the construct being measured. For symptom domains such as Anxiety, Depression, Fatigue, Sleep Disturbance, and Pain Interference, higher scores indicate worse symptoms; for Physical Function and Ability to Participate in Social Roles and Activities, higher scores indicate better functioning.",{"measure":60,"description":61,"timeFrame":51},"University of Washington Concerns About Pain Scale (UW-CAP) 6-item short form))","The University of Washington Concerns About Pain Scale 6-item short form (UW-CAP-6) assesses pain catastrophizing, described in the instrument as concerns about pain. Each item uses five response options coded from 1 to 5. The six item codes are summed only as an intermediate raw score (range 6 to 30) and then converted using the published concordance table to an item response theory (IRT)-based T-score. The T-score, rather than the raw sum, will be reported and analyzed. Higher T-scores indicate greater concerns about pain; the calibration metric has a mean of 50 and standard deviation of 10.",{"measure":63,"description":64,"timeFrame":65},"Patient Global Impression of Change (PGIC)","The Patient Global Impression of Change (PGIC) is a single-item participant-reported measure of overall change in activity limitations, symptoms, emotions, and quality of life related to the painful condition. Responses are rated on a 7-point scale from 1 = No change (or condition has gotten worse) to 7 = A great deal better, with higher scores indicating greater perceived improvement. Scores of 5, 6, and 7 correspond to moderately better, better, and a great deal better, respectively.","12 weeks and 24 weeks",{"measure":67,"description":68,"timeFrame":69},"The STarT Back Screening Tool (SBST)","The STarT (Subgroups for Targeted Treatment) Back Screening Tool (SBST) was developed as a risk stratification tool for future persistent disabling low back pain. This tool is comprised of 9 items (scored 0 or 1 point). Scores range from 0 to 9. Participants with scores of 3 or lower may have a low risk for future persistent disabling low back pain and related activity limitations. Participants with scores of 4 or higher have an increased risk for these same outcomes. There is also a Psychosocial Distress Subscore that distinguishes between medium and high risk subgroups, based on the last five items of the tool. Participants with a Distress Subscore of 0-3 points are categorized as medium risk and those with a Distress Subscore of 4 or higher are considered high risk for persistent disabling back pain.","Baseline",null,{"allocation":72,"interventionModel":73,"interventionModelDescription":74,"primaryPurpose":75,"observationalModel":70,"timePerspective":70,"maskingInfo":76},"RANDOMIZED","PARALLEL","Participants are randomized 1:1 to EPPAC or usual care. The same trained psychologists may deliver both conditions based on routine clinical availability.","HEALTH_SERVICES_RESEARCH",{"masking":77,"maskingDescription":78,"whoMasked":70},"NONE","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.","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.\n\nClinical 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.\n\nDespite 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.\n\nParticipant 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.\n\nTo 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.",[81,87],{"label":82,"type":83,"description":84,"interventionNames":85},"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\u002FPERT treatment is routine clinical care and is available in both study arms.",[86],"Behavioral: Empowering Pain Psychology Access and Collaboration (EPPAC)",{"label":88,"type":89,"description":90,"interventionNames":91},"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.",[92],"Behavioral: Usual Care Pain Psychology Evaluation",[94,98],{"type":95,"name":82,"description":96,"armGroupLabels":97,"otherNames":70},"BEHAVIORAL","EPPAC 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.",[82],{"type":95,"name":99,"description":100,"armGroupLabels":101,"otherNames":70},"Usual Care Pain Psychology Evaluation","Usual 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.",[88],[103],{"name":104,"affiliation":5,"role":105},"Fenan S Rassu, Ph.D.","PRINCIPAL_INVESTIGATOR",[107,111],{"name":104,"role":108,"phone":109,"phoneExt":70,"email":110},"CONTACT","667-306-7983","frassu1@jhmi.edu",{"name":112,"role":108,"phone":113,"phoneExt":70,"email":114},"Rachel V Aaron, Ph.D.","667-306-7797","raaron4@jhmi.edu",[116],{"facility":117,"status":70,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":129},"Johns Hopkins Rehabilitation Psychology Clinic","Baltimore","Maryland","21205","United States","US",{"type":124,"coordinates":125},"Point",[126,127],-76.61219,39.29038,{"lat":127,"lon":126},[130,132,133,134],{"name":131,"role":108,"phone":109,"phoneExt":70,"email":110},"Fenan S Rass, Ph.D.",{"name":112,"role":108,"phone":113,"phoneExt":70,"email":114},{"name":104,"role":105,"phone":70,"phoneExt":70,"email":70},{"name":112,"role":135,"phone":70,"phoneExt":70,"email":70},"SUB_INVESTIGATOR",{"type":137,"investigatorFullName":70,"investigatorTitle":70,"investigatorAffiliation":70,"oldNameTitle":70,"oldOrganization":70},"SPONSOR",[139],{"name":140,"class":141},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100657921","empowering-pain-psychology-access-and-collaboration-eppac-to-improve-treatment-engagement-among-medicaid-insured-adults-with-chronic-low-back-pain-100657921",false,"NCT07843706","Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain","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","Inclusion Criteria:\n\n* 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%\n* Medicaid insurance as primary or secondary coverage documented in the medical record, including eligible dual Medicare-Medicaid coverage\n* Able to complete study procedures in English\n* Able to participate in the telehealth clinical workflow and complete online questionnaires, with telephone assistance when needed\n\nExclusion Criteria:\n\n* Specific spinal pathology or medical condition requiring immediate intervention that makes study participation inappropriate\n* Currently receiving psychological treatment specifically for chronic pain at the time of screening\n* Lumbar spine surgery within the past 6 months\n* Severe psychiatric, cognitive, or substance-related condition that interferes with safe participation or meaningful consent\n* Enrollment in another interventional study for chronic low back pain that could confound study outcomes\n* Current cancer other than skin cancer","ALL","18 Years","64 Years",{"count":153,"type":154},70,"ESTIMATED","INTERVENTIONAL",[157],"NA","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.",[160],"Chronic Low Back Pain (CLBP)",[162,163,164,165,166,167,168,169,170,171],"chronic low back pain","pain psychology","shared decision-making","motivational interviewing","participant engagement","health disparities","Medicaid","pilot randomized controlled trial","cognitive behavioral therapy","emotional awareness and expression therapy","NOT_YET_RECRUITING","2026-10-08",{"date":175,"type":176},"2026-10-09","ACTUAL",{"date":178,"type":154},"2026-11-02",{"date":180,"type":154},"2029-02-28",{"name":5,"class":6},1]