Recruiting

CIH Stepped Care vs. Treatment As Usual

Sponsor:

University of Washington

Code:

NCT06219408

Conditions

Chronic Pain

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CIH Stepped Care

Study Details

Brief 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

Chronic Pain

Posttraumatic Stress Disorder

Study ID

NCT06219408

Start date

Feb 18, 2026

Status verified date

Nov, 2025

Completion date

Aug 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: Treatment as Usual

Treatment as usual at the clinic

Interventions

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 measure

  • Feasibility of Intervention Measure [ Time Frame: 6-months ]
  • Acceptability of Intervention Measure [ Time Frame: 6-months ]
  • Appropriateness of Intervention Measure [ Time Frame: 6-months ]
  • Participant Retainment [ Time Frame: 6-months ]

Central Contacts and Locations

Central contacts

David Reed, PhD

206-543-3752davider2@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

University of Washington

Last update posted

Feb 27, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2026-02-27.