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

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

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.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Washington (Academic / other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT06219408 on ClinicalTrials.gov

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.

Who should consider this trial

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).

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.

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 performed: 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.

Eligibility 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 this trial is running

Seattle, Washington

• University of Washington — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: David Reed, PhD — University of Washington
• Study coordinator: David Reed, PhD

Conditions Chronic Pain; Posttraumatic Stress Disorder