Integrating Mind-Body Practices Into Primary Care Treatment

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Posttraumatic Stress Disorder
• Interventions: Behavioral: CIH Stepped Care

• Registration Number: NCT06219408
• Lead Sponsor: University of Washington

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-29
• Study Start: 2025-06-02
• Primary Completion: 2027-04-30
• Study Completion: 2028-02-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIH Stepped Care	CIH Stepped Care	A mindfulness-based and meaning-based stepped care approach for treating co-occurring chronic pain and PTSD that will begin with less intensive treatment (e.g., psychoeducation) and, based on patient response and preference, will be "stepped up" to more intensive treatment when appropriate.

Primary Outcome Measures

Name	Time	Method
Clinician-administered posttraumatic stress disorder scale	Baseline, 3-months, 6-months, 9-months	PTSD symptoms; 0-80; higher scores indicate worse outcome
Patient Reported Outcome Measurement System - Pain Interference	Baseline, 3-months, 6-months, 9-months	Pain interference; 0-100; higher scores indicate worse outcome

Secondary Outcome Measures

Name	Time	Method
Item 1 from Flourishing Measure	Measurement-based care (assessed every 2-weeks until study completion), Baseline, 3-months, 6-months, 9-months	Emotional well-being; 0-10; higher scores indicate better outcome
Short Form-12 - Physical Health	Baseline, 3-months, 6-months, 9-months	Physical health functioning; 0-12; higher scores indicate better outcome
Meaning in Life Questionnaire	Baseline, 3-months, 6-months, 9-months	Meaning in life; 1-7; higher scores indicate better outcome
pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G)	Screening, measurement-based care (assessed every 2-weeks until study completion), Baseline, 3-months, 6-months, 9-months	Pain severity and interference; 0-10; higher scores indicate worse outcome
Posttraumatic stress disorder checklist for DSM-5	Screening, measurement-based care (assessed every 2-weeks until study completion)	PTSD Symptoms; 0-80; higher scores indicate worse outcome
Patient Health Questionnaire - Item 9	Screening, Baseline, 3-months, 6-months, 9-months	Suicidal ideation; 0-3; higher scores indicate worse outcome
Short Form-12 - Mental Health	Baseline, 3-months, 6-months, 9-months	Mental health functioning; 0-12; higher scores indicate better outcome
Five Facet Mindfulness Questionnaire	Baseline, 3-months, 6-months, 9-months	Mindfulness; 1-5; higher scores indicate better outcome

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States