Recruiting

Pain Management App

Sponsor:

UCLA

Code:

NCT06183281

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CBT, Mindfulness, and Movement

Study Details

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

Study ID

NCT06183281

Start date

Apr 28, 2025

Status verified date

Jul, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. age 18 or older
2. speak English, Spanish, or Cantonese
3. have a UCSF Health or SFHN medical provider (any type)
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

Study Design

Enrollment

586 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

CBT, Mindfulness, and Movement

Blended CBT, mindfulness, and movement delivered through a mobile app and supported by a weekly telehealth pain management coach.

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 and Locations

Central contacts

Jason Satterfield, PhD

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

Locations

San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

Contacts

Eleanor Schwarz, MD

415-206-2372Eleanor.Schwarz@ucsf.edu

Lisa Ochoa-Frongia, MD

415-476-4082Lisa.Ochoa-Frongia@ucsf.edu

UCSF Adult Primary Care Mt. Zion Clinic

Recruiting

San Francisco, California, United States, 94115

Contacts

Jason Satterfield, PhD

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

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-27.