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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06219408
• Other study ID #: STUDY00015530
• Secondary ID: K99AT012054
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2, 2025
• Est. completion date: February 29, 2028

Study information

• Verified date: February 2024
• Source: University of Washington
• Contact: David Reed, PhD
• Phone: 803-767-3384
• Email: davider2[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 29, 2028
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. 18 years or older

2. English-speaking

3. Have a recent University of Washington system visit (within 6 months of data pull). At that index visit the potential patient participant must have a diagnosis indicating the presence of pain and at least one prior visit with diagnosis indicating the presence of pain at least three months apart (using International Classification of Diseases [ICD] codes). This timeframe will ensure that the patient meets the standard criteria for a chronic pain designation. Pain will include back pain, neck pain, limb/extremity pain, joint pain, arthritic disorders (except gout and neuropathic arthropathy), fibromyalgia, headache, orofacial, ear, and temporomandibular disorder, musculoskeletal chest pain, and/or other pain.

4. At least a 4 on the pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G; PEG) at the time of study screening.

5. Posttraumatic stress disorder (PTSD) diagnosis at any 2021-2023 visit (using ICD codes) and/or screen positive for significant PTSD symptoms (=31 on the PTSD Checklist-5 [PCL-5]) with a Criterion A event and/or destabilizing life event. Difficulty in recruitment may result in contingency plans, including reducing the PCL-5 cutoff score to 28, using subthreshold "Majority" ("Meeting three of the four DSM-5 criterion categories") and/or a "Five symptom" designation ("Meeting at least one symptom in each criterion [i.e., at least one B, C, D, and E symptom], but not meet fully-threshold PTSD") definitions.

Exclusion Criteria

1. Current suicidal ideation and intent identified at the time of study screening/informed consent.

2. Severe cognitive impairment preventing individual from participating

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Barriers/facilitators of success	Qualitative check-ins related to barriers/facilitators of success	Baseline, 3-months, 6-months, 9-months
Other	Feasibility of Intervention Measure	Feasibility of Intervention; 1-5; higher scores indicate better outcome	6-months
Other	Acceptability of Intervention Measure	Acceptability of Intervention; 1-5; higher scores indicate better outcome	6-months
Other	Appropriateness of Intervention Measure	Appropriateness of Intervention; 1-5; higher scores indicate better outcome	6-months
Other	Costs of Intervention delivery/services used	Costs of Intervention delivery/services used	6-months
Primary	Patient Reported Outcome Measurement System - Pain Interference	Pain interference; 0-100; higher scores indicate worse outcome	Baseline, 3-months, 6-months, 9-months
Primary	Clinician-administered posttraumatic stress disorder scale	PTSD symptoms; 0-80; higher scores indicate worse outcome	Baseline, 3-months, 6-months, 9-months
Secondary	pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G)	Pain severity and interference; 0-10; higher scores indicate worse outcome	Screening, measurement-based care (assessed every 2-weeks until study completion), Baseline, 3-months, 6-months, 9-months
Secondary	Posttraumatic stress disorder checklist for DSM-5	PTSD Symptoms; 0-80; higher scores indicate worse outcome	Screening, measurement-based care (assessed every 2-weeks until study completion)
Secondary	Item 1 from Flourishing Measure	Emotional well-being; 0-10; higher scores indicate better outcome	Measurement-based care (assessed every 2-weeks until study completion), Baseline, 3-months, 6-months, 9-months
Secondary	Five Facet Mindfulness Questionnaire	Mindfulness; 1-5; higher scores indicate better outcome	Baseline, 3-months, 6-months, 9-months
Secondary	Patient Health Questionnaire - Item 9	Suicidal ideation; 0-3; higher scores indicate worse outcome	Screening, Baseline, 3-months, 6-months, 9-months
Secondary	Short Form-12 - Physical Health	Physical health functioning; 0-12; higher scores indicate better outcome	Baseline, 3-months, 6-months, 9-months
Secondary	Short Form-12 - Mental Health	Mental health functioning; 0-12; higher scores indicate better outcome	Baseline, 3-months, 6-months, 9-months
Secondary	Meaning in Life Questionnaire	Meaning in life; 1-7; higher scores indicate better outcome	Baseline, 3-months, 6-months, 9-months