# Integrating nonpharmacologic strategies for pain with Inclusion, Respect, and Equity (INSPIRE): a digital health study protocol for a pragmatic multisite randomized controlled trial

## TL;DR

This study tests a digital health program to improve chronic pain treatment access for diverse populations using non-drug therapies.

## Contribution

A novel multilingual digital intervention combining nonpharmacologic therapies with telehealth coaching to address chronic pain disparities.

## Key findings

- The INSPIRE trial will assess outcomes like pain reduction and quality of life over 12 months.
- The study focuses on culturally tailored digital health access for underserved populations.
- Primary analysis will use intention-to-treat methods with baseline covariates.

## Abstract

Chronic pain (CP) is among the most common medical conditions, is the leading cause of disability, and is often refractory to medical treatment. The CDC and the American College of Physicians recommend nonopioid and nonpharmacologic treatment as first-line strategies, including cognitive-behavioral therapy (CBT), mindfulness-based interventions (MBI), and movement-focused interventions (MFI); however, only 3% of people with chronic pain (CP) have access to these evidence-based treatments. Patients from historically minoritized populations and those speaking languages other than English are particularly underserved and may go untreated. Stigma regarding CP and interventions to manage it present additional obstacles.

The Integrating Nonpharmacologic Strategies for Pain with Inclusion, Respect, and Equity (INSPIRE) study evaluates a blend of these non-pharmacologic, evidence-based interventions using a pragmatic, parallel, two-arm RCT comparing intervention participants with wait-list controls. The INSPIRE intervention includes a 12-week curriculum delivered via a multilingual mobile app paired with weekly telehealth coaching. The primary outcome will be the “Pain, Enjoyment, and General Activity (PEG)” scores at 3 months. Secondary outcomes include PEG scores at 6 and 12 months, physical functioning, quality of life, sleep, depression, anxiety, and global satisfaction with treatment at 3, 6, and 12 months. Primary mediators to be examined include pain cognitions and health behaviors. Secondary mediators may include stigma and isolation, trust in healthcare providers, and both engagement and satisfaction with the INSPIRE intervention. The intention-to-treat primary analysis will be conducted with covariates including baseline measures of pain, anxiety, and physical function.

The full RCT protocol and intervention details are provided following the SPIRIT guidelines. Implications for improving treatment access via culturally and linguistically tailored digital health interventions are discussed along with the potential for health coaching to drive mobile app engagement.

ClinicalTrials.gov ID NCT06183281. Trial registration data set can be found here: https://clinicaltrials.gov/study/NCT06183281 and in Additional file 1.

The online version contains supplementary material available at 10.1186/s13063-025-09402-8.