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NCT Number: NCT06688864

Under-Resourced Adults With Chronic Pain eHealth 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Eleshia J. Morrison

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EPIO App

Behavioral

Participants will receive access to the app-based cognitive-behavioral pain self-management intervention program (EPIO) for 3 months.

Primary outcomes

  1. Change in West Haven Yale Multiphasic Pain Inventory (WHYMPI) score

    Time frame: Baseline, 6 weeks

    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 outcomes

  1. Change in Concerns About Pain-Short Form (CAP)

    Time frame: Baseline, 6 weeks

    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.

  2. Change in Pain Self-Efficacy Questionnaire (PSEQ) score

    Time frame: Baseline, 6 weeks

    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.

  3. Change in Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) score

    Time frame: Baseline, 6 weeks

    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.

  4. Change in Hospital Anxiety and Depression Scale (HADS) score

    Time frame: Baseline, 6 weeks

    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.

  5. Change in Short Form-36 score

    Time frame: Baseline, 6 weeks

    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.

  6. Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C) score

    Time frame: Baseline, 6 weeks

    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.

  7. Change in Perceived Stress Scale (PSS) score

    Time frame: Baseline, 6 weeks

    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).

  8. System Usability Scale score (SUS)

    Time frame: 6 weeks

    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.

  9. Everyday Discrimination Scale-Expanded (EDS-E) score

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Eleshia J. Morrison, Ph.D.

CONTACT

[email protected]

507-255-1791

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: Flourish

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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