CIH Stepped Care for Co-occurring Chronic Pain and PTSD
NCT06219408 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-02-27
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).
Conditions
Interventions
- BEHAVIORAL
-
CIH 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.
Sponsors & Collaborators
-
National Center for Complementary and Integrative Health (NCCIH)
collaborator NIH - lead OTHER
Principal Investigators
-
David Reed, PhD · University of Washington
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-18
- Primary Completion
- 2027-05-30
- Completion
- 2027-08-30
Countries
- United States
Study Locations
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