Clinical trial NCT06219408: Integrating Mind-Body Practices Into Primary Care Treatment
Official title: Integrating Mind-Body Practices Into Primary Care Treatment: The IMPaCT Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Posttraumatic Stress Disorder
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Reported Outcome Measurement System - Pain Interference
timeFrame: Baseline, 3-months, 6-months, 9-months
measure: Clinician-administered posttraumatic stress disorder scale
timeFrame: Baseline, 3-months, 6-months, 9-months
Secondary outcomes:
measure: pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G)
timeFrame: Screening, measurement-based care (assessed every 2-weeks until study completion), Baseline, 3-months, 6-months, 9-months
measure: Posttraumatic stress disorder checklist for DSM-5
timeFrame: Screening, measurement-based care (assessed every 2-weeks until study completion)
measure: Item 1 from Flourishing Measure
timeFrame: Measurement-based care (assessed every 2-weeks until study completion), Baseline, 3-months, 6-months, 9-months
measure: Five Facet Mindfulness Questionnaire
timeFrame: Baseline, 3-months, 6-months, 9-months
measure: Patient Health Questionnaire - Item 9
timeFrame: Screening, Baseline, 3-months, 6-months, 9-months
measure: Short Form-12 - Physical Health
timeFrame: Baseline, 3-months, 6-months, 9-months
measure: Short Form-12 - Mental Health
timeFrame: Baseline, 3-months, 6-months, 9-months
measure: Meaning in Life Questionnaire
timeFrame: Baseline, 3-months, 6-months, 9-months
Other outcomes:
measure: Barriers/facilitators of success
timeFrame: Baseline, 3-months, 6-months, 9-months
measure: Feasibility of Intervention Measure
timeFrame: 6-months
measure: Acceptability of Intervention Measure
timeFrame: 6-months
measure: Appropriateness of Intervention Measure
timeFrame: 6-months
measure: Costs of Intervention delivery/services used
timeFrame: 6-months
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: David Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: