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Recruiting NCT06183281

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

No phase Interventional Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CBT, Mindfulness, and Movement.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity (INSPIRE): Tailored Digital Tools, Telehealth Coaching, and Primary Care Coordination

Overview

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]
Secondary outcome measures (12)
  • Change from Baseline in Physical Functioning on the 5-point PROMIS Physical Function Short Form 6b [Time frame: Baseline, 3mo, 6mo, 12mo]
  • Change from Baseline in Sleep Disturbance and Sleep Duration on the 5-point PROMIS Sleep Disturbance Short Form 6a [Time frame: Baseline, 3mo, 6mo, 12mo]
  • Change from Baseline in Fear and Anxiety about Pain on the 5-point Pain Catastrophizing Scale Short Form 6 [Time frame: Baseline, 3mo, 6mo, 12mo]
  • Change from Baseline in Self-reported Depressive Symptoms on the 4-point Patient Health Questionnaire - 9 (PHQ-9) [Time frame: Baseline, 3mo, 6mo, 12mo]
  • Change from Baseline in Self-reported Anxiety Symptoms on the 4-point General Anxiety Scale (GAD-7) [Time frame: Baseline, 3mo, 6mo, 12mo]
  • Change from Baseline in Overall Satisfaction with Treatment on the 7-point Patient Global Impression of Change (PGIC) [Time frame: Baseline, 3mo, 6mo, 12mo]
  • Change from Baseline in Self-reported Alcohol Use Disorder Symptoms on the 5-point Alcohol Use Disorder Identification Test (AUDIT) [Time frame: Baseline, 3mo, 6mo, 12mo]
  • Change from Baseline in Drug Abuse Screening Test (DAST) Score [Time frame: Baseline, 3mo, 6mo, 12mo]
  • Change from Baseline in Internalized Stigma of Mental Illness on the 4-point Internalized Stigma of Mental Illness Inventory (ISMI) [Time frame: Baseline, 3mo, 6mo, 12mo]
  • Change from Baseline in Self-reported Social Isolation on the 5-point PROMIS Social Isolation Short Form 8a [Time frame: Baseline, 3mo, 6mo, 12mo]
  • Change from Baseline in Clinician Self-reported Attitudes, Beliefs, and Perspectives about Mental Illness on the 5-point Opening Minds Survey for Health Care Providers [Time frame: Baseline, 3mo, 6mo, 12mo]
  • Change from Baseline in Patient Self-reported Trust of their Healthcare Provider(s) on the 5-point PROMIS Healthcare Relationship Trust (HCR) Scale [Time frame: Baseline, 3mo, 6mo, 12mo]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • San Francisco General Hospital — San Francisco
  • UCSF Adult Primary Care Mt. Zion Clinic — San Francisco

Publications

  • 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

Identifiers

NCT: NCT06183281 · R33NS129050 · R61NS129050 · R33NS129050

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗