The PROmoting Pain Self-Management (PROs) Trial: Holistic Pain Care in the Military Health System

Part of paid clinical trials in Fairbanks, Alaska.

Sponsor
Brooke Army Medical Center
Study ID
NCT06940986
Status
Recruiting

Conditions

  • Chronic Pain
  • Musculoskeletal Pain
  • Musculoskeletal Pain Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empowered Relief — BEHAVIORAL
    ER is provided in a single, 2-hour session delivered remotely by trained instructors. ER has two main components: didactics and skills acquisition as outlined below. The ER class is administered virtually. The class includes the didactic and skill acquisition content. At the end of the class participants receive tangible items including the self-crafted, personalized catastrophizing cessation plan, a guided relaxation response audio file, and an electronic copy of the didactic class content.
  • Move to Health — BEHAVIORAL
    The M2H intervention is delivered virtually by trained health coaches using a 6-step process. The administration of M2H begins with an initial session with follow-up sessions scheduled every 1-2 weeks for up to 8 weeks or until the participant is ready to transition to self-management.
  • Usual Care as determined by primary care provider — OTHER
    Patients will receive care as determined by their primary care provider, with no input or control by the research team.

Study Details

The goal of this study is to improve pain care in the MHS by identifying effective, whole-person, non-pharmacologic interventions for persons with chronic musculoskeletal pain. The investigators will evaluate two promising, evidence-based holistic health interventions and compare them to usual care.

Key Dates

Start date
Dec 19, 2025
Status verified
May 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
608 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Empowered Relief
    Empowered Relief uses a single, 2-hour session to accomplish several key tasks including; pain education; experiential exercises; didactic content on pain responses, stress, and tension; techniques to affect the relaxation response; basic unhelpful thought restructuring; self-soothing actions; and completion of a per-sonalized self-management plan for empowered relief. Similar to CBT relaxation, ER participants receive a calming tool in the form of a binaural app. Unlike CBT, ER is mainly didactic, omits content such as activity planning and pacing, and is provided in a single session, eliminating ongoing therapeutic alliance and peer support.
  • Active Comparator: Move to Health
    Move to Health (M2H) is part of an initiative in the Military Health System to transform healthcare delivery with emphasis on the power of holistic care and self-management. M2H is operationalized using a health coaching model based on collaborative part-nership between patient and a trained coach to facilitate healthy behavior change. Health coaching is an evidence-based intervention for persons with chronic pain with improvements in physical activity, pain intensity and interference.
  • Active Comparator: Usual Care
    Usual care (UC) pain management will be provided at the discretion of the participant's primary care provider, consistent with a pragmatic clinical trial. Persons assigned to UC will be advised to follow the recommendations from their primary care provider and will be provided information about local resources at their respective Military Treatment Facility. The study team will not take additional steps to standardize or compel adherence to practice guidelines and will collect health care utilization outcomes through the the Millitary Health System Data Repository at the conclusion of the trial.

Primary Outcome Measure

3-PEG Scale [ Time Frame: From enrollment to the end of treatment at 14 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Bassett Army Community HospitalFairbanksAlaska99703
Karyn Zaage (PRINCIPAL_INVESTIGATOR)
Desmond Doss Health ClinicSchofield BarracksHawaii96786
Aliona Megedyuk, BS
808-433-5963
Roy Camacho, DPT (PRINCIPAL_INVESTIGATOR)
Brooke Army Medical CenterSan AntonioTexas78219
Tina Greenlee, PhD
210-808-2575
Benjamin Hando (PRINCIPAL_INVESTIGATOR)
Wilford Hall Ambulatory Surgical CenterSan AntonioTexas78236
Tina Greenlee, PhD
Josh VanWyndgaarden (PRINCIPAL_INVESTIGATOR)
Madigan Army Medical CenterTacomaWashington98391
Rachel J Mayhew, DPT
Nicholas Molby (PRINCIPAL_INVESTIGATOR)

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