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

Chronic Pain Clinical Trial

— INSPIRE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06183281
• Other study ID #: R61NS129050
• Secondary ID: R61NS129050
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: August 1, 2027

Study information

• Verified date: December 2023
• Source: University of California, San Francisco
• Contact: Jason Satterfield, PhD
• Phone: 415-353-2104
• Email: Jason.Satterfield[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 586
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age 18 or older

2. speak English, Spanish, or Cantonese

3. have a UCSF Health or SFHN PCP

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• CBT, Mindfulness, and Movement
Blended CBT, mindfulness, and movement delivered through a mobile app and supported by a weekly telehealth pain management coach.

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California
United States	UCSF Adult Primary Care Mt. Zion Clinic	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Neurological Disorders and Stroke (NINDS), University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Baseline, 3mo, 6mo, 12mo
Secondary	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)	Baseline, 3mo, 6mo, 12mo
Secondary	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)	Baseline, 3mo, 6mo, 12mo
Secondary	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)	Baseline, 3mo, 6mo, 12mo
Secondary	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)	Baseline, 3mo, 6mo, 12mo
Secondary	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)	Baseline, 3mo, 6mo, 12mo
Secondary	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)	Baseline, 3mo, 6mo, 12mo
Secondary	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)	Baseline, 3mo, 6mo, 12mo
Secondary	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)	Baseline, 3mo, 6mo, 12mo
Secondary	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)	Baseline, 3mo, 6mo, 12mo
Secondary	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.	Baseline, 3mo, 6mo, 12mo
Secondary	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)	Baseline, 3mo, 6mo, 12mo
Secondary	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)	Baseline, 3mo, 6mo, 12mo
Secondary	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)	Baseline, 3mo, 6mo, 12mo