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Chronic PainINSPIRENCT06183281

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

A study testing CBT, Mindfulness, and Movement in people with Chronic Pain, run by University of California, San Francisco at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
CBT, Mindfulness, and Movement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
586 participants
Where
2 sitesUnited States
Study dates
28 Apr 2025to 31 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Severe mental illness or other condition preventing informed consent

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jason Satterfield, PhD contact

415-353-2104

Jason.Satterfield@ucsf.edu

United States2 sites, 2 recruiting
  • San Francisco General Hospital

    San Francisco, California, 94110

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

    Lisa Ochoa-Frongia, MD, 415-476-4082 ext. 411, Lisa.Ochoa-Frongia@ucsf.edu

    Recruiting
  • UCSF Adult Primary Care Mt. Zion Clinic

    San Francisco, California, 94115

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

    Adrian Aguilera, PhD

    Recruiting

Other trials in United States

About this study

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

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
Being tested
CBT, Mindfulness, and Movement
Keywords
Non-malignant chronic pain, Digital health, Health coaching, Health equity, Cognitive therapy, Mindfulness, Movement
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT, Mindfulness, and MovementBehavioural

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

Study groups in NCT06183281
Study groupRoleWhat they receive
InterventionExperimentalThe 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).
Receives: Behavioral: CBT, Mindfulness, and Movement
ControlNo interventionControl participants will receive educational materials about chronic pain and full workbook with non-pharmacologic strategies.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline, 3mo, 6mo, 12mo

Secondary outcomes (14)
  1. Change from Baseline in Physical Functioning on the 5-point PROMIS Physical Function Short Form 6b

    The PROMIS Physical Function Short Form 6b is a validated, self-reported 6-question survey assessing someone's ability to do household chores, to go up and down stairs at a normal pace, to go for a 15-minute walk, to run errands or shop, to do more than two hours of physical labor, and to do moderate work around the house. Possible scores for each question range from 1 (unable to do) to 5 (able to do without difficulty). Lower scores are indicative of lower levels of physical functioning. Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

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

    The PROMIS Sleep Disturbance Short Form 6a is a validated, self-reported 6-question survey assessing quality of sleep. Possible scores for each question range from 1 (very good) to 5 (very poor). A higher score indicates greater sleep disturbance. Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

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

    The Pain Catastrophizing Scale Short Form 6 is a validated, self-reported 6-question survey assessing thoughts and feelings that someone may have about their pain. Possible scores for each question range from 0 (not at all, no catastrophizing thoughts and feelings) to 4 (all the time, constant catastrophizing thoughts and feelings). Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

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

    The PHQ-9 is a validated, self-reported 9-question survey assessing common symptoms of depression. Possible scores for each question range from 0 (not at all) to 3 (nearly every day). A higher score indicates a higher likelihood of depression. Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

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

    The GAD-7 is a validated, self-reported 7-question survey assessing common symptoms of anxiety. Possible scores for each question range from 0 (not at all) to 3 (nearly every day). A higher score indicates a higher likelihood of general anxiety. Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

  6. Change from Baseline in Overall Satisfaction with Treatment on the 7-point Patient Global Impression of Change (PGIC)

    The Patient Global Impression of Change (PGIC) is a validated, self-reported 1-question survey assessing how much a patient's pain has improved since the start of treatment. Possible scores range from 0 (very much improved) to 6 (very much worse). Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

  7. Change from Baseline in Self-reported Alcohol Use Disorder Symptoms on the 5-point Alcohol Use Disorder Identification Test (AUDIT)

    The Alcohol Use Disorder Identification Test (AUDIT) is a validated, self-reported 10-question survey assessing common symptoms of alcohol use disorder. Possible scores for each question range from 0 (never) to 4 (4 or more times per week). Scores for each question are added up. A score of 8 or higher is considered to indicate hazardous or harmful alcohol use. Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

  8. Change from Baseline in Drug Abuse Screening Test (DAST) Score

    The Drug Abuse Screening Test (DAST) is a validated, self-reported 10-question survey assessing risk of drug abuse. Each question is answered with a "yes" or a "no". Answers that indicate possible risk of drug abuse are given a score of 1, while answers that do not indicate possible risk of drug abuse are given a score of 0. The scores for each question are then added together. Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

  9. Change from Baseline in Internalized Stigma of Mental Illness on the 4-point Internalized Stigma of Mental Illness Inventory (ISMI)

    The Internalized Stigma of Mental Illness Inventory (ISMI) is a validated, self-reported 29-question survey assessing a patient's attitude, beliefs, and behaviors relating to their mental illness. Possible scores range from 1 (strongly disagree) to 4 (strongly agree). The scores for each question are added together. A higher score indicates greater internalized stigma of mental illness. Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

  10. Change from Baseline in Self-reported Social Isolation on the 5-point PROMIS Social Isolation Short Form 8a

    The PROMIS Social Isolation Short Form 8a is a validated, self-reported 8-question survey assessing a the extent to which someone feels isolated socially. Possible scores range from 1 (never) to 5 (always). The scores for each question are added together. A higher score indicates more severe isolation. Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

  11. 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

    The Opening Minds Survey for Health Care Providers is a validated, self-reported 20-question survey assessing health care providers' attitudes, beliefs, and perspectives about mental illness. Possible responses to each question are "Strongly Disagree", "Disagree", "Neither Agree nor Disagree", "Agree", and "Strongly Agree". No numeric scores are assigned to responses. Changes in responses between each time point and baseline will be evaluated qualitatively.

    Measured: Baseline, 3mo, 6mo, 12mo

  12. Change from Baseline in Patient Self-reported Trust of their Healthcare Provider(s) on the 5-point PROMIS Healthcare Relationship Trust (HCR) Scale

    The Healthcare Relationship Trust Scale is a validated, self-reported 13-question survey assessing how a patient feels about their health care provider. Possible scores range from 0 (none of the time) to 4 (all of the time). The scores for each question are added together. A higher score indicates greater trust of the patient's health care provider. Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

  13. Change from Baseline in Self-reported Pain Self-Efficacy on the 7-point Pain Self-Efficacy Questionnaire - Two Item Short Form (PSEQ-2)

    The Pain Self-Efficacy Questionnaire Two Item Short Form (PSEQ-2) is a validated, self-reported 2-question survey assessing a patient's ability to live and work despite their pain. Possible scores range from 0 (not at all confident) to 6 (completely confident). The scores for each question are added together. A higher score indicates greater self-efficacy. Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

  14. Change from Baseline in Self-reported Psychological Inflexibility on the 7-point Psychological Inflexibility in Pain Scale

    The Psychological Inflexibility in Pain Scale is a validated, self-reported 12-question survey assessing how a patient accepts and adapts to a life with chronic pain. Possible scores range from 1 (never true) to 7 (always true). The scores for each question are added together. A higher score indicates greater psychological inflexibility in pain. Change = (score at time point - score at baseline)

    Measured: Baseline, 3mo, 6mo, 12mo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2023
  2. Study start28 Apr 2025
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized into intervention or enhanced usual care conditions
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
586 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06183281
Sponsor's protocol ID
R33NS129050
Other IDs
R61NS129050, R33NS129050
Acronym
INSPIRE
Status last verified
Jul 2026
First submitted
13 Aug 2023
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This project is part of the Helping to End Addiction Longterm (HEAL) initiative and will use the data sharing platform required for that consortia.

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.

    PubMed 41507957

Questions about this trial

What is this clinical trial studying?

A study testing CBT, Mindfulness, and Movement in people with Chronic Pain, run by University of California, San Francisco at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jason Satterfield, PhD (415-353-2104, Jason.Satterfield@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06183281, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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