CIH Stepped Care for Co-occurring Chronic Pain and PTSD

A Pilot Randomized Controlled Trial of CIH Stepped Care for Co-occurring Chronic Pain and PTSD

The goal of this clinical trial is to evaluate the feasibility, acceptability, appropriateness, and retention of patient participants of a CIH Stepped Care approach for co-occurring chronic pain and PTSD vs. treatment as usual in two primary care settings (one rural and one urban).

Researchers will compare CIH Stepped Care to treatment as usual.

Participants will complete assessments at baseline, 3-months, 6-months, and 9-months, and those in the CIH Stepped Care condition will participate in the intervention while also completed assessments every 2-weeks, which helps determine their treatment.

We hypothesize that, at 6-months, CIH Stepped Care will be feasible, acceptable, and appropriate (defined by an average of 4/5 on each measure) to patients and clinic employees and result in at least 70% of individuals be retained in each condition (n=21 per condition).

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: CIH Stepped 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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Reed, PhD; Phone Number: 206-543-3752; Email: davider2@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: David E. Reed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

There are two populations of study. The first is clinic employees who work at primary care, family medicine, or similar clinics. The second is individuals with co-occurring chronic pain and PTSD.

Description

Inclusion Criteria

In order to be eligible to participate in this study, clinic employees must meet all of the following criteria:

1. Aged 18 years or older
2. A clinic employee and/or trainee

In order to be eligible to participate in this study, patients must meet all of the following criteria:

1. Aged 18 years or older
2. English-speaking
3. A patient at the clinic from which recruitment occurs
4. Endorse chronic pain (defined as experiencing pain on more than half of the days of the past 3-months)
5. Endorse at least moderate pain severity and interference (defined as at least an average of 4 on the PEG)
6. Endorse at least 31 on the PCL-5, in combination with a Criterion A traumatic event. If we have difficulties in recruiting individuals who meet our PTSD diagnosis criteria, we will modify this criteria by removing the requirement of a Criterion A traumatic event, and require a destabilizing life event instead.

4.2 Exclusion Criteria

There are no exclusion criteria for clinic employees.

Patients who meet any of the following criteria will be excluded from participation in this study:

1. In current treatment for chronic pain and/or PTSD at their respective clinic
2. Past 2-week suicidal intention at screening
3. Severe cognitive impairment preventing individual from participating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as Usual; Treatment as usual at the clinic
Experimental: CIH Stepped Care; CIH Stepped Care is a stepped approach to care delivered by a health coach (e.g., psychologist-in-training or clinical social worker) in-person or remotely (individual person sessions). It is 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.	Behavioral: CIH Stepped Care; CIH Stepped Care is a stepped approach to care delivered by a health coach (e.g., psychologist-in-training or clinical social worker) in-person or remotely (individual person sessions). It is 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Intervention Measure	Feasibility of intervention; 1-5; higher scores indicate greater feasibility	6-months
Acceptability of Intervention Measure	Acceptability of Intervention; 1-5; higher scores indicate greater acceptability	6-months
Appropriateness of Intervention Measure	Appropriateness of Intervention; 1-5; higher scores indicate greater appropriateness	6-months
Participant Retainment	Percentage of Participants Retained in Intervention Arm	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Diagnostic Scale for DSM-5	PTSD symptoms; 0-80; higher scores indicate more severe PTSD symptoms	Baseline, 3-, 6-, and 9-months
Patient Reported Outcome Measurement System - Pain Interference	Pain interference; 0-100; higher scores indicate worse pain interference	Baseline, 3-, 6-, and 9-months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PEG	Pain severity and interference; 0-10; higher scores indicate more pain severity and interference	Measurement-based care (every 2 weeks for those in CIH Stepped Care)
Harvard's Flourishing Measure - Happiness and Life Satisfaction	Happiness and Life Satisfaction; 0-10; higher scores indicate greater happiness and life satisfaction	Baseline, 3-, 6-, and 9-Months
Harvard's Flourishing Scale - Meaning and Purpose	Meaning and Purpose (every 2 weeks for those in CIH Stepped Care); 0-10; higher scores indicate greater meaning and purpose	Measurement-based care
Emotion Regulation Questionnaire-Short Form	Cognitive re-appraisal; 3-21; higher scores indicate greater cognitive re-appraisal	Baseline, 3-, 6-, and 9-months
Metacognitive Processes of Decentering Scale	Decentering; 0-10; higher scores indicate higher decentering	Baseline, 3-, 6-, and 9-months
Meaning in Life Questionnaire	Meaning in Life; 1-7; higher scores indicate more meaning in life	Baseline, 3-, 6-, and 9-months
Existential Phenomenological Questionnaire - Short Form	Existential Anxiety; 1-5; higher scores indicate more existential anxiety	Baseline, 3-, 6-, and 9-months
Five Facet Mindfulness Questionnaire	Mindfulness; 24-120; higher scores indicate more mindfulness	Baseline, 3-, 6-, and 9-months
Columbia-Suicide Severity Rating Scale - Self-Report	Suicidality; 6 items; risk levels of high, moderate, low/no risk are determined	3-, 6-, and 9-months
GAD-7	Anxiety; 0-21; higher scores indicate more severe anxiety symptoms	Baseline, 3-, 6-, and 9-Months
PHQ-9	Depression; 0-27; higher scores indicate more severe depression symptoms	Baseline, 3-, 6-, and 9-Months
PROMIS-Physical Health	Physical Health; 0-100 T-scores; higher scores indicate greater physical health function	Baseline, 3-, 6-, and 9-Months
Working Alliance Inventory-Short Revised-Therapist	Therapeutic Alliance; 1-7; higher scores indicate greater working patient-provider therapeutic alliance	3- and 6-months
Reason for Dropout	1-item on why participant discontinued study	6-months
Fidelity of CIH Stepped Care	Treatment fidelity; percentage of items completed; greater percentage indicates higher fidelity	6-months
PTSD Checklist for DSM-5	PTSD Symptoms; 0-80; higher scores indicate higher PTSD symptom severity	Measurement-based care (every 2 weeks for those in CIH Stepped Care)
Adherence	Adherence (defined as completing over 50% of the measurement-based care assessments that occur every 2 weeks and completing participant-health coach measurement-based care contacts, where, for instance, treatment options would be discussed)	6-months
Medication use	Medication use (name, dose, and frequency)	Baseline, 3-, 6-, and 9-months
Healthcare use	Healthcare use; frequency of different healthcare services used (e.g., primary care visits)	Baseline, 3-, 6-, and 9-months
Treatment Change	1-item asking patients in the CIH Stepped Care condition whether they would like to change treatments	Measurement-based care (every 2 weeks for those in CIH Stepped Care)
Working Alliance Inventory-Short Revised-Client	Therapeutic Alliance; 1-7; higher scores indicate greater working patient-provider therapeutic alliance	3- and 6-months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: David Reed, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Stress Disorders, Traumatic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: STUDY00015530; R00AT012054 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be de-identified and approved by the PI.
• IPD Sharing Time Frame: IPD and supporting information will be available after all data has been collected until data is destroyed.
• IPD Sharing Access Criteria: Researchers and others whose goal is to advance the science of improving care for those with chronic pain.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No