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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
First received
Last updated
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
Health authority
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

Study Design


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
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