Actively Recruiting
A Pilot Randomized Controlled Trial of CIH Stepped Care for Co-occurring Chronic Pain and PTSD
Led by University of Washington · Updated on 2026-02-27
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a CIH Stepped Care approach compared to treatment as usual for adults with co-occurring chronic pain and posttraumatic stress disorder (PTSD) in two primary care settings, one rural and one urban. This pilot randomized controlled trial aims to assess the feasibility, acceptability, appropriateness, and participant retention of the CIH Stepped Care model, which is mindfulness-based and meaning-centered. The study hypothesizes that by 6 months, these measures will indicate positive reception and at least 70% retention in each treatment condition. The CIH Stepped Care intervention is delivered by a health coach, such as a psychologist-in-training or clinical social worker, through individual sessions either in-person or remotely. This approach begins with less intensive treatments like psychoeducation and can be stepped up to more intensive therapies based on patient response and preference. Participants are randomly assigned to either receive this stepped care or continue with treatment as usual at their clinic. Participants will be assessed at baseline, 3, 6, and 9 months. Those in the CIH Stepped Care group will also complete assessments every two weeks to guide their treatment progression. Researchers will measure feasibility, acceptability, appropriateness, and retention at 6 months as primary outcomes. Secondary outcomes include PTSD symptoms and pain interference. The total study period extends over at least 9 months, with ongoing monitoring through regular assessments.
CONDITIONS
Brief Title
CIH Stepped Care for Co-occurring Chronic Pain and PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- English-speaking
- A patient at the clinic from which recruitment occurs
- Endorse chronic pain (pain on more than half of the days in the past 3 months)
- Have at least moderate pain severity and interference (average of 4 or higher on the PEG scale)
- Have PTSD symptoms with a score of at least 31 on the PCL-5 combined with a Criterion A traumatic event or a destabilizing life event if recruitment criteria are adjusted
You will not qualify if you...
- Currently receiving treatment for chronic pain and/or PTSD at the clinic
- Past 2-week suicidal intention at screening
- Severe cognitive impairment preventing participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 6 months
Participants receive stepped care treatment delivered by a health coach in-person or remotely, starting with less intensive sessions and stepping up to more intensive care based on response and preference.
Individual sessions with a health coach as scheduled
Duration - Up to 3 months after treatment
Participants continue to be assessed for PTSD symptoms and pain interference to monitor progress after treatment.
Assessments at 3, 6, and 9 months including surveys and questionnaires
Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
D
David Reed, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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