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Partners for Pain & Wellbeing: A Randomized Trial of Community Supported Complementary and Integrative Health Self Management for Back Pain
The goal of this clinical trial is to learn how well two community-based self-management programs work in people with chronic back or neck pain. The main question it aims to answer is: How well does a community-based self-management program teaching mind-body skills such as mindfulness and cognitive behavioral approaches (Partners4Pain) work for reducing pain intensity and interference with general activities and enjoyment of life compared to a community-based self-management program focused on general health and wellbeing (Keys to Wellbeing)? Participants will be asked to do the following: * Attend 2 screening visits to learn about the study and see if they meet the requirements to participate. * Be randomly assigned to one of the two community-based self-management programs. * Attend 9 weekly self-management program sessions (90 minutes each) * Complete surveys about their pain and overall health at 2 months (after the programs end), 4 months, and 6 months. Funding for the project is provided through the National Center for Complementary and Integrative Health (NCCIH) and the National Institute of Neurological Disorders and Stroke (NINDS) through the NIH HEAL Initiative (https://heal.nih.gov/), R33AT012309.
This project is a full-scale, multi-level randomized hybrid effectiveness implementation trial (n=376) of 'Partners4Pain', a community supported self-management program for individuals with back or neck pain. Partners4Pain will be compared to an active control, Keys to Wellbeing. Both programs were optimized and feasibility tested in an earlier R61 pilot study of 51 individuals (NCT05786508). Aims for the hybrid effectiveness implementation trial are: AIM 1. To assess the relative effectiveness of Partners4Pain versus Keys to Wellbeing in terms of: * Primary effectiveness outcomes of pain intensity and interference over 6 months using bi-monthly assessments. * Secondary effectiveness outcomes of pain impact, self-efficacy and other HEAL outcomes. AIM 2. To assess the impact of health factors on the effectiveness of Partners4Pain for primary and secondary outcomes through subgroup analyses which account for potential complexities between factors. AIM 3. To describe important implementation related measures that can impact and inform sustained translation of the program with community partner organizations.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Minnesota
Minneapolis, Minnesota, United States
Start Date
January 6, 2025
Primary Completion Date
August 1, 2027
Completion Date
August 1, 2027
Last Updated
December 15, 2025
376
ESTIMATED participants
Partners4Pain
BEHAVIORAL
Keys to Wellbeing
BEHAVIORAL
Lead Sponsor
University of Minnesota
Collaborators
NCT06661850
NCT03836248
NCT04379115
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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