Under-Resourced Adults With Chronic Pain eHealth Study (Flourish)

Delivery of an eHealth Intervention for Under-resourced Adults With Chronic Pain (Flourish Study)

The purpose of this study is to examine the feasibility of the dissemination of a cognitive-behavioral eHealth application (app) for pain self-management with Black and LGBTQ+ adults with high-impact chronic pain lasting at least 3 months and disrupting daily functioning (Implementation aim).

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: EPIO App

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eleshia J. Morrison, Ph.D.; Phone Number: 507-255-1791; Email: Morrison.Eleshia@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Eleshia J. Morrison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Identify as Black and/or LGBTQ+
• Reside in USA
• Chronic pain diagnosis for at least 3 months.
• Experience chronic pain that makes it harder to do their day-to-day activities
• Have daily access to a smart mobile device (smartphone or table) and are willing to use the EPIO app.

Exclusion Criteria:

• Unable or unwilling to use the digital app for the study
• Do not have daily access to a smart mobile device (smartphone or tablet)
• Self-report cancer related pain, or severe untreated psychological illness (e.g., psychosis); and/or do not fit into one of the demographic categories listed in #1-3 for inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Black adults with chronic pain	Behavioral: EPIO App; Participants will receive access to the app-based cognitive-behavioral pain self-management intervention program (EPIO) for 3 months.
Experimental: LGBTQIA+ adults with chronic pain	Behavioral: EPIO App; Participants will receive access to the app-based cognitive-behavioral pain self-management intervention program (EPIO) for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in West Haven Yale Multiphasic Pain Inventory (WHYMPI) score	The West Haven Yale Multiphasic Pain Inventory (WHYMPI) is a 52-item measure of various domains of the experience of pain, including pain interference (primary intervention outcome) and pain severity with daily functioning.	Baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Everyday Discrimination Scale-Expanded (EDS-E) score	The Everyday Discrimination Scale-Expanded (EDS-E) is a self-report measure used to assess the frequency of various forms of discrimination experienced by individuals in their day-to-day lives. It consists of 10 items, each rated on a 5-point Likert scale from 0 (never) to 4 (very often).	Baseline
Change in Concerns About Pain-Short Form (CAP)	The Concerns About Pain-Short Form (CAP) is a 6-item measure of the nature of cognitive appraisals in response to pain and has been validated for use in diverse patient populations.	Baseline, 6 weeks
Change in Pain Self-Efficacy Questionnaire (PSEQ) score	The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain.	Baseline, 6 weeks
Change in Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) score	The Chronic Pain Acceptance Questionnaire (CPAQ-R) consists of 20 items, with 10 items each for the subscales of Activity Engagement and Pain Willingness. The items on the CPAQ are rated on a 7-point scale from 0 (never true) to 6 (always true). Higher scores indicate higher levels of acceptance.	Baseline, 6 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score	The Hospital Anxiety and Depression Scale is a 14-item scale with seven items each for the anxiety and depression symptom subscales. For both subscales, a score of 8-10 indicates mild symptoms, 11-14 indicates moderate symptoms, and 15-21 indicates severe symptoms.	Baseline, 6 weeks
Change in Short Form-36 score	The SF-36 Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability.	Baseline, 6 weeks
Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C) score	The AUDIT-C consists of three questions, and each question has 5 answer choices valued from 0 points to 4 points. The AUDIT-C is scored on a scale of 0-12. A score of 4 for men and a score of 3 for women can raise suspicion of alcohol use disorder.	Baseline, 6 weeks
Change in Perceived Stress Scale (PSS) score	The 10-item Perceived Stress Scale (PSS) measures global perceived stress experienced by the participant over the preceding 30 days. The questions in this assessment tool ask how often the participant felt or thought a certain way during the past month. Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often. Possible scores range from 0 to 40, with lower scores indicating a better outcome (less stress).	Baseline, 6 weeks
System Usability Scale score (SUS)	The System Usability Scale is a 10-item measure of overall usability of the app regarding perceived usefulness and ease of use. The overall score is in a range from 0-100, with a higher score indicating better user satisfaction.	6 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Eleshia J. Morrison, Ph.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: 23-009761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No