NCT06219408 · University of Washington
CIH Stepped Care for Co-occurring Chronic Pain and PTSD
What this study is about
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.
View original scientific description
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).
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.
Primary outcome measures
Feasibility of Intervention Measure
Time frame: 6-months
Feasibility of intervention; 1-5; higher scores indicate greater feasibility
Acceptability of Intervention Measure
Time frame: 6-months
Acceptability of Intervention; 1-5; higher scores indicate greater acceptability
Appropriateness of Intervention Measure
Time frame: 6-months
Appropriateness of Intervention; 1-5; higher scores indicate greater appropriateness
Participant Retainment
Time frame: 6-months
Percentage of Participants Retained in Intervention Arm
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. 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:
- 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
Where
- Seattle, Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations