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Recruiting NCT06688864

Under-Resourced Adults With Chronic Pain eHealth Study

No phase Interventional Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EPIO App.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Change in West Haven Yale Multiphasic Pain Inventory (WHYMPI) score [Time frame: Baseline, 6 weeks]
Secondary outcome measures (9)
  • Change in Concerns About Pain-Short Form (CAP) [Time frame: Baseline, 6 weeks]
  • Change in Pain Self-Efficacy Questionnaire (PSEQ) score [Time frame: Baseline, 6 weeks]
  • Change in Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) score [Time frame: Baseline, 6 weeks]
  • Change in Hospital Anxiety and Depression Scale (HADS) score [Time frame: Baseline, 6 weeks]
  • Change in Short Form-36 score [Time frame: Baseline, 6 weeks]
  • Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C) score [Time frame: Baseline, 6 weeks]
  • Change in Perceived Stress Scale (PSS) score [Time frame: Baseline, 6 weeks]
  • System Usability Scale score (SUS) [Time frame: 6 weeks]
  • Everyday Discrimination Scale-Expanded (EDS-E) score [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06688864 · 23-009761

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗