Integrating Mind-Body Practices Into Primary Care Treatment

Chronic Pain Clinical Trial

Official title: Integrating Mind-Body Practices Into Primary Care Treatment: The IMPaCT Pilot Study

Status Not yet recruiting

Clinical Trial Summary

The current study is a pilot RCT of a CIH stepped approach to care.

Clinical Trial Description

The current study (Aim 3 of the larger project) is a pilot randomized controlled trial of a complementary and integrative health (CIH) stepped approach to care. Patients will be recruited out of one urban and one rural primary care clinic. The stepped care approach will be consistent with current national guidelines and existing stepped approaches. In collaboration with WWAMI (Washington, Wyoming, Alaska, Montana, and Idaho) Primary Care Research Network, clinic providers (e.g., a nurse) will be recruited to become trained health coaches (6-8 hours of training; n=3 per site, which will ideally be the same number used in a future R01 multisite trial). Health coaches will provide initial mindfulness-based education, monitor measurement-based care assessments, ensure feedback is provided to the prepared primary care clinic, and connect patients with qualified/licensed CIH providers from the fixed-menu of options (i.e., they will not deliver those interventions themselves). Priorities of care and when to "step up" care will be a team decision including the primary care physician, and these decisions will take place during normal clinical team procedures to minimize burden and maximize sustainability. Patients will be able to continue their normal engagement with medical care, which will not be altered or delayed, including any conventional posttraumatic stress disorder (PTSD) and pain interventions. Patient adherence/provider fidelity to the intervention will be assessed, with Aims 1 and 2 helping determine how "successful" adherence/fidelity thresholds are established. Health coaches will also complete measures of feasibility, acceptability, and appropriateness at 6-months (using Weiner's 2017 assessments, see Table 9). Brief qualitative check-ins (monthly and when needed) with all health coaches and 1-2 clinic staff/administrators per clinic will focus on the clinic's ability to integrate these new procedures into existing clinic procedures, which will be used to improve the approach in real-time, in addition to informing the future R01 multisite trial. Patients will complete clinical effectiveness measures at 3-,6-, and 9-months, in addition to a treatment satisfaction assessment at 6-months (See Table 9). Time costs (e.g., measurement-based care, time to connect to outside CIH interventions) will be assessed at 6-months.

Potential Stepped care Prototype: A clinic provider (e.g., a nurse) will be trained as a health coach, who will guide participants through each step of the approach, monitor measurement-based care (every 2 weeks), provide feedback to the primary care physician/Care Team, and serve as the provider of the mindfulness-based patient education intervention of Step 2. The primary care setting will be a prepared primary care clinic (e.g., using University of Washington (UW) Medicine's electronic MyChart for measurement-based care). The prepared primary care clinic will include staff and providers trained in the stepped approach, technological capabilities that provide feedback to the primary care physician, methods to identify new patients with chronic pain and PTSD, and connecting to CIH interventions. The approach would begin with 1 session of self-management strategies and education, and symptom monitoring through measurement-based care (well-being, pain severity/interference, and PTSD via UW Medicine's MyChart). If the patient does not see improvement on 2/3 assessments or wants to alter treatment, the patient would be "stepped up" to a brief (4-6 sessions) mindfulness-based psycho-education weekly intervention that could be delivered by a health coach. The intervention draws heavily on current stepped strategies for pain (developed by mentor Dr. Kroenke) and PTSD (developed by consultant Dr. Zatzick) and would include brief mindfulness-based strategies and Veterans Affairs "Whole Health" resources. If the patient does not improve after the intervention, they will be connected to CIH services based on a fixed menu of evidence-based options. Patient preference and symptom severity will play a critical role; patients could begin with more intensive treatments if desired/clinically indicated. ;

Related Conditions & MeSH terms

• Chronic Pain
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

• NCT number: NCT06219408
• Study type: Interventional
• Source: University of Washington
• Contact: David Reed, PhD
• Phone: 803-767-3384
• Email: davider2@uw.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2, 2025
• Completion date: February 29, 2028