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CIH Stepped Care for Co-occurring Chronic Pain and PTSD
NCT06219408 · University of Washington
In plain English
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Official title
A Pilot Randomized Controlled Trial of CIH Stepped Care for Co-occurring Chronic Pain and PTSD
About this study
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).
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
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-02-18
Estimated completion: 2027-08-30
Last updated: 2026-02-27
Interventions
Behavioral: CIH Stepped Care
Primary outcomes
- • Feasibility of Intervention Measure (6-months)
- • Acceptability of Intervention Measure (6-months)
- • Appropriateness of Intervention Measure (6-months)
Sponsor
University of Washington · other
With: National Center for Complementary and Integrative Health (NCCIH)
Contacts & investigators
ContactDavid Reed, PhD · contact · davider2@uw.edu · 206-543-3752
InvestigatorDavid Reed, PhD · principal_investigator, University of Washington
All locations (1)
University of WashingtonRecruiting
Seattle, Washington, United States