NCT06183281 · University of California, San Francisco
Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity
(INSPIRE)
What this study is 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 treatment group$1 pilot starting in Nov 2023.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
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
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Severe mental illness or other condition preventing informed consent
Where
- San Francisco, California
Collaborators
University of California, Berkeley, National Institute of Neurological Disorders and Stroke (NINDS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 27, 2026 · Source of record for eligibility and locations