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NCT Number: NCT06219408

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.

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).

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Key information

Conditions

Chronic Pain Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Posttraumatic Stress Disorder Signs and Symptoms Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

Location status: Recruiting

Location contact

David E. Reed

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CIH Stepped Care

Behavioral

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 outcomes

  1. Feasibility of Intervention Measure

    Time frame: 6-months

    Feasibility of intervention; 1-5; higher scores indicate greater feasibility

  2. Acceptability of Intervention Measure

    Time frame: 6-months

    Acceptability of Intervention; 1-5; higher scores indicate greater acceptability

  3. Appropriateness of Intervention Measure

    Time frame: 6-months

    Appropriateness of Intervention; 1-5; higher scores indicate greater appropriateness

  4. Participant Retainment

    Time frame: 6-months

    Percentage of Participants Retained in Intervention Arm

Secondary outcomes

  1. PTSD Diagnostic Scale for DSM-5

    Time frame: Baseline, 3-, 6-, and 9-months

    PTSD symptoms; 0-80; higher scores indicate more severe PTSD symptoms

  2. Patient Reported Outcome Measurement System - Pain Interference

    Time frame: Baseline, 3-, 6-, and 9-months

    Pain interference; 0-100; higher scores indicate worse pain interference

Other outcomes

  1. PEG

    Time frame: Measurement-based care (every 2 weeks for those in CIH Stepped Care)

    Pain severity and interference; 0-10; higher scores indicate more pain severity and interference

  2. Harvard's Flourishing Measure - Happiness and Life Satisfaction

    Time frame: Baseline, 3-, 6-, and 9-Months

    Happiness and Life Satisfaction; 0-10; higher scores indicate greater happiness and life satisfaction

  3. Harvard's Flourishing Scale - Meaning and Purpose

    Time frame: Measurement-based care

    Meaning and Purpose (every 2 weeks for those in CIH Stepped Care); 0-10; higher scores indicate greater meaning and purpose

  4. Emotion Regulation Questionnaire-Short Form

    Time frame: Baseline, 3-, 6-, and 9-months

    Cognitive re-appraisal; 3-21; higher scores indicate greater cognitive re-appraisal

  5. Metacognitive Processes of Decentering Scale

    Time frame: Baseline, 3-, 6-, and 9-months

    Decentering; 0-10; higher scores indicate higher decentering

  6. Meaning in Life Questionnaire

    Time frame: Baseline, 3-, 6-, and 9-months

    Meaning in Life; 1-7; higher scores indicate more meaning in life

  7. Existential Phenomenological Questionnaire - Short Form

    Time frame: Baseline, 3-, 6-, and 9-months

    Existential Anxiety; 1-5; higher scores indicate more existential anxiety

  8. Five Facet Mindfulness Questionnaire

    Time frame: Baseline, 3-, 6-, and 9-months

    Mindfulness; 24-120; higher scores indicate more mindfulness

  9. Columbia-Suicide Severity Rating Scale - Self-Report

    Time frame: 3-, 6-, and 9-months

    Suicidality; 6 items; risk levels of high, moderate, low/no risk are determined

  10. GAD-7

    Time frame: Baseline, 3-, 6-, and 9-Months

    Anxiety; 0-21; higher scores indicate more severe anxiety symptoms

  11. PHQ-9

    Time frame: Baseline, 3-, 6-, and 9-Months

    Depression; 0-27; higher scores indicate more severe depression symptoms

  12. PROMIS-Physical Health

    Time frame: Baseline, 3-, 6-, and 9-Months

    Physical Health; 0-100 T-scores; higher scores indicate greater physical health function

  13. Working Alliance Inventory-Short Revised-Therapist

    Time frame: 3- and 6-months

    Therapeutic Alliance; 1-7; higher scores indicate greater working patient-provider therapeutic alliance

  14. Reason for Dropout

    Time frame: 6-months

    1-item on why participant discontinued study

  15. Fidelity of CIH Stepped Care

    Time frame: 6-months

    Treatment fidelity; percentage of items completed; greater percentage indicates higher fidelity

  16. PTSD Checklist for DSM-5

    Time frame: Measurement-based care (every 2 weeks for those in CIH Stepped Care)

    PTSD Symptoms; 0-80; higher scores indicate higher PTSD symptom severity

  17. Adherence

    Time frame: 6-months

    Adherence (defined as completing over 50% of the measurement-based care assessments that occur every 2 weeks and completing participant-health coach measurement-based care contacts, where, for instance, treatment options would be discussed)

  18. Medication use

    Time frame: Baseline, 3-, 6-, and 9-months

    Medication use (name, dose, and frequency)

  19. Healthcare use

    Time frame: Baseline, 3-, 6-, and 9-months

    Healthcare use; frequency of different healthcare services used (e.g., primary care visits)

  20. Treatment Change

    Time frame: Measurement-based care (every 2 weeks for those in CIH Stepped Care)

    1-item asking patients in the CIH Stepped Care condition whether they would like to change treatments

  21. Working Alliance Inventory-Short Revised-Client

    Time frame: 3- and 6-months

    Therapeutic Alliance; 1-7; higher scores indicate greater working patient-provider therapeutic alliance

Study contacts

Contact information is provided by the study sponsor or research team.

David Reed, PhD

CONTACT

[email protected]

206-543-3752

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

A Pilot Randomized Controlled Trial of CIH Stepped Care for Co-occurring Chronic Pain and PTSD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 23, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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