Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Stepped complementary and integrative health care for people with chronic pain and PTSD

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

Run by University of Washington · NCT06219408 · Data updated 2026-11-12

This will try a stepped complementary and integrative health (CIH) program to see if it is acceptable and helpful for adults with chronic pain and PTSD in primary care compared with usual care.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorUniversity of Washington
Academic / other
Locations1 site (Seattle, Washington)
StatusRecruiting
StartedFebruary 18, 2026
Main results expectedMay 30, 2027
Study endsAugust 30, 2027
Registry record updatedFebruary 27, 2026
Trial IDNCT06219408 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) who are patients at the participating clinics, English-speaking, report chronic pain (pain on more than half the days over the past 3 months) with at least moderate pain severity/interference (PEG ≥4), and meet probable PTSD criteria (PCL-5 ≥31 with a Criterion A event or a destabilizing life event).

Probably not a fit

Patients who do not have both chronic pain and probable PTSD, who cannot engage with CIH activities or attend required visits, or who require immediate specialty or inpatient care are unlikely to benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot compares a stepped complementary and integrative health (CIH) pathway to treatment-as-usual for adults with co-occurring chronic pain and PTSD in two primary care clinics (one rural, one urban). Eligible patients are enrolled and assigned to either the CIH Stepped Care program or usual care and complete assessments at baseline, 3, 6, and 9 months. Participants in the CIH arm also complete brief assessments every two weeks that guide progression through stepped CIH interventions. Primary outcomes focus on feasibility, acceptability, appropriateness, and retention, with predefined targets for retention and average acceptability/appropriateness scores.

Why it matters

Potential benefit: If successful, this approach could provide a patient-tailored CIH pathway that improves symptom management and keeps more patients engaged in primary care for both pain and PTSD.

How similar studies have gone: CIH approaches and stepped-care models have shown promise separately for chronic pain or PTSD, but combined stepped CIH for co-occurring pain and PTSD is relatively novel and not yet widely tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University of Washington
    Seattle, Washington, United States
    Recruiting

Study contacts

  • Principal investigator: David Reed, PhD — University of Washington
  • Study coordinator: David Reed, PhD
  • Email: davider2@uw.edu
  • Phone: 206-543-3752

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.