Under-Resourced Adults with Chronic Pain EHealth Study

Not Applicable

Recruiting

• Conditions: Chronic Pain

• Registration Number: NCT06688864
• Lead Sponsor: Mayo Clinic

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-25
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Identify as Black or LGBTQ+.
• Reside in MN, WI, or IA.
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in West Haven Yale Multiphasic Pain Inventory (WHYMPI) score	Baseline, 3 months	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.

Secondary Outcome Measures

Name	Time	Method
System Usability Scale score (SUS)	3 months	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.
Everyday Discrimination Scale-Expanded (EDS-E) score	Baseline	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).
Change in Pain Catastrophizing Scale (PCS) score	Baseline, 3 months	The Pain Catastrophizing Scale (PCS) is a self-report questionnaire designed to assess catastrophic thinking related to pain. It consists of 13 items, each rated on a 5-point scale from 0 (not at all) to 4 (all the time). The total score ranges from 0 to 52, with higher scores indicating greater levels of catastrophizing.
Change in Pain Self-Efficacy Questionnaire (PSEQ) score	Baseline, 3 months	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.
Change in Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) score	Baseline, 3 months	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.
Change in Hospital Anxiety and Depression Scale (HADS) score	Baseline, 3 months	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.
Change in Short Form-36 score	Baseline, 3 months	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.
Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C) score	Baseline, 3 months	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.
Change in Perceived Stress Scale (PSS) score	Baseline, 3 months	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).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States