Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity (INSPIRE)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Chronic Pain

Treatments: Behavioral: CBT, Mindfulness, and Movement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06183281

R33NS129050 (U.S. NIH Grant/Contract)

R61NS129050 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 586 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 18 or older
2. speak English, Spanish, or Cantonese
3. have a UCSF Health or SFHN PCP
4. be willing to use a smartphone (iOS or Android - either their own or one provided by the study)
5. have chronic, non-malignant pain for at least 3 months
6. be willing to participate in a 12 month patient-centered chronic pain management study where they will be randomized into one of two comparison arms

Exclusion criteria

• Severe mental illness or other condition preventing informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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586 participants in 2 patient groups

Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: CBT, Mindfulness, and Movement

Control

No Intervention group

Description:

Control participants will receive educational materials about chronic pain and full workbook with non-pharmacologic strategies.