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

NCT06183281 | Recruiting

• 2 other identifiers: R33NS129050R61NS129050
• Study Type: interventional
• Target: 586
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Pain

Keywords

Non-malignant chronic pain; Digital health; Health coaching; Health equity; Cognitive therapy; Mindfulness; Movement

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Pain Intensity and Interference on the 11-point Pain, Enjoyment of Life, and General Activity Scale (PEG)

  The PEG Pain Screening Tool is a validated, self-reported 3-question survey assessing pain severity, the extent to which pain interferes with enjoyment of life, and the extent to which pain interferes with general activity. Possible scores for each question range from 0 (no pain, no interference) to 10 (worst possible pain, worst possible interference). The average of scores from the three questions yields the PEG score. Change = (PEG score at time point - PEG score at baseline)

  Baseline, 3mo, 6mo, 12mo

Secondary Outcomes (14)

• Change from Baseline in Physical Functioning on the 5-point PROMIS Physical Function Short Form 6b

  Baseline, 3mo, 6mo, 12mo

• Change from Baseline in Sleep Disturbance and Sleep Duration on the 5-point PROMIS Sleep Disturbance Short Form 6a

  Baseline, 3mo, 6mo, 12mo

• Change from Baseline in Fear and Anxiety about Pain on the 5-point Pain Catastrophizing Scale Short Form 6

  Baseline, 3mo, 6mo, 12mo

• Change from Baseline in Self-reported Depressive Symptoms on the 4-point Patient Health Questionnaire - 9 (PHQ-9)

  Baseline, 3mo, 6mo, 12mo

• Change from Baseline in Self-reported Anxiety Symptoms on the 4-point General Anxiety Scale (GAD-7)

  Baseline, 3mo, 6mo, 12mo

Study Arms (2)

Intervention

EXPERIMENTAL

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).

Behavioral: CBT, Mindfulness, and Movement

Control

NO INTERVENTION

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

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older
• speak English, Spanish, or Cantonese
• have a UCSF Health or SFHN medical provider (any type)
• be willing to use a smartphone (iOS or Android - either their own or one provided by the study)
• have chronic, non-malignant pain for at least 3 months
• 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

You may not qualify if:

• Severe mental illness or other condition preventing informed consent

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Berkeley: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

UCSF Adult Primary Care Mt. Zion Clinic

San Francisco, California, 94115, United States

RECRUITING

Related Publications (1)

• Ristau J, Okobi A, Miller MJ, Cheng J, Deviren S, Schwarz EB, Fairchild T, Tsoh JY, Aguilera A, Zheng-Huang CJ, Satterfield JM. Integrating nonpharmacologic strategies for pain with Inclusion, Respect, and Equity (INSPIRE): a digital health study protocol for a pragmatic multisite randomized controlled trial. Trials. 2026 Jan 8;27(1):109. doi: 10.1186/s13063-025-09402-8.

  PMID: 41507957 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Mindfulness; Movement

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jason Satterfield, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Satterfield, PhD

CONTACT

415-353-2104; Jason.Satterfield@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized into intervention or enhanced usual care conditions

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: December 27, 2023
• Study Start: April 15, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)