RecruitingNot ApplicableNCT06219408

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


Sponsor

University of Washington

Enrollment

60 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria10

  • In order to be eligible to participate in this study, clinic employees must meet all of the following criteria:
  • Aged 18 years or older
  • A clinic employee and/or trainee
  • In order to be eligible to participate in this study, patients must meet all of the following criteria:
  • Aged 18 years or older
  • English-speaking
  • A patient at the clinic from which recruitment occurs
  • Endorse chronic pain (defined as experiencing pain on more than half of the days of the past 3-months)
  • Endorse at least moderate pain severity and interference (defined as at least an average of 4 on the PEG)
  • 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.

Exclusion Criteria4

  • Patients who meet any of the following criteria will be excluded from participation in this study:
  • In current treatment for chronic pain and/or PTSD at their respective clinic
  • Past 2-week suicidal intention at screening
  • Severe cognitive impairment preventing individual from participating

Interventions

BEHAVIORALCIH 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.


Locations(1)

University of Washington

Seattle, Washington, United States

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NCT06219408


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