Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Location contact
Eleshia J. Morrison
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06688864
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Eleshia J. Morrison
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive access to the app-based cognitive-behavioral pain self-management intervention program (EPIO) for 3 months.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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).
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
Delivery of an eHealth Intervention for Under-resourced Adults With Chronic Pain (Flourish Study)
Acronym: Flourish
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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