Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06183281
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pain

Eligibility Criteria

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

Interventions

  • CBT, Mindfulness, and Movement — BEHAVIORAL
    Blended CBT, mindfulness, and movement delivered through a mobile app and supported by a weekly telehealth pain management coach.

Study Details

INSPIRE creates a trilingual mobile app and telehealth coaching program to promote non-pharmacologic strategies for pain management with Black, Chinese, and Latinx communities in the San Francisco Bay Area. Years 1-2 will develop the app and test it with a brief single arm pilot starting in Nov 2023. A full two arm randomized controlled trial (RCT) will being in early 2025 with changes in PEG scores as the primary outcome. Secondary outcomes include Helping to End Addiction Longterm (HEAL) common data elements.

Key Dates

Start date
Apr 15, 2025
Status verified
Apr 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

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

Arms

  • Experimental: Intervention
    The INSPIRE chronic pain management system has three primary components: 1) a patient facing smartphone app that collects and interprets a comprehensive intake and patient reported outcomes (PROs), provides health education, and a tailored, modular self-management program that includes cognitive-behavioral therapy (CBT), physical therapy (PT), and mindfulness-based interventions (MBI), 2) a weekly telehealth visit with a pain coach that uses the PRO data and module engagement measures to guide the visit, and 3) enhanced primary care coordination achieved through pain coaching notes and alerts integrated into the electronic health record (EHR).
  • No Intervention: Control
    Control participants will receive educational materials about chronic pain and full workbook with non-pharmacologic strategies.

Primary Outcome Measure

Change from Baseline in Pain Intensity and Interference on the 11-point Pain, Enjoyment of Life, and General Activity Scale (PEG) [ Time Frame: Baseline, 3mo, 6mo, 12mo ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
San Francisco General HospitalSan FranciscoCalifornia94110
Eleanor Schwarz, MD
[email protected]
415-206-2372
Lisa Ochoa-Frongia, MD
[email protected]
415-476-4082
UCSF Adult Primary Care Mt. Zion ClinicSan FranciscoCalifornia94115
Jason Satterfield, PhD
[email protected]
415-353-2104
Adrian Aguilera, PhD (SUB_INVESTIGATOR)
Matthew Miller, PhD (SUB_INVESTIGATOR)
Sibel Deviren, MD (SUB_INVESTIGATOR)
Janice Tsoh, PhD (SUB_INVESTIGATOR)
Arthur Wood, MD (SUB_INVESTIGATOR)

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By research site
San Francisco General Hospital· San Francisco, CAUCSF Adult Primary Care Mt. Zion Clinic· San Francisco, CA

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