Chronic PainNCT06219408
CIH Stepped Care for Co-occurring Chronic Pain and PTSD
A study testing CIH Stepped Care in people with Chronic Pain and Posttraumatic Stress Disorder, run by University of Washington at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Posttraumatic Stress Disorder
- What is being tested?
- CIH Stepped Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
David E. Reed
About this study
Official title: A Pilot Randomized Controlled Trial of CIH Stepped Care for Co-occurring Chronic Pain and PTSD
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.
Read more
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
- Being tested
- CIH Stepped Care
- Medical subject headings
- Chronic Pain, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIH Stepped CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CIH Stepped Care | Experimental | 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. Receives: Behavioral: CIH Stepped Care |
| Treatment as Usual | No intervention | Treatment as usual at the clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure
Feasibility of intervention; 1-5; higher scores indicate greater feasibility
Measured: 6-months
Acceptability of Intervention Measure
Acceptability of Intervention; 1-5; higher scores indicate greater acceptability
Measured: 6-months
Appropriateness of Intervention Measure
Appropriateness of Intervention; 1-5; higher scores indicate greater appropriateness
Measured: 6-months
Participant Retainment
Percentage of Participants Retained in Intervention Arm
Measured: 6-months
Secondary outcomes (2)
PTSD Diagnostic Scale for DSM-5
PTSD symptoms; 0-80; higher scores indicate more severe PTSD symptoms
Measured: Baseline, 3-, 6-, and 9-months
Patient Reported Outcome Measurement System - Pain Interference
Pain interference; 0-100; higher scores indicate worse pain interference
Measured: Baseline, 3-, 6-, and 9-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start18 Feb 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, David Reed, University of Washington
- Investigators
- David Reed, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219408
- Sponsor's protocol ID
- STUDY00015530
- Other IDs
- R00AT012054
- Status last verified
- Nov 2025
- First submitted
- 12 Jan 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be de-identified and approved by the PI.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of CIH Stepped Care for Co-occurring Chronic Pain and PTSD
- ClinicalTrials.gov ID
- NCT06219408
- Acronym / sponsor ID
- STUDY00015530
- Conditions
- Chronic Pain, Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIH Stepped Care | Experimental | Behavioral: CIH Stepped CareCIH 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. |
| Treatment as Usual | No intervention | –Treatment as usual at the clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIH Stepped CareCIH 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. | Behavioural | CIH Stepped Care |
Primary outcome
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
2 secondary outcomes
PTSD Diagnostic Scale for DSM-5
Time frame: Baseline, 3-, 6-, and 9-months
Patient Reported Outcome Measurement System - Pain Interference
Time frame: Baseline, 3-, 6-, and 9-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. IPD will be de-identified and approved by the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Reed, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIH Stepped Care in people with Chronic Pain and Posttraumatic Stress Disorder, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Reed, PhD (206-543-3752, davider2@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (time frame: 6-months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.