CIH Stepped Care for Co-occurring Chronic Pain and PTSD

NCT06219408 | Recruiting DMC

• 2 other identifiers: STUDY00015530R00AT012054
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Feasibility of Intervention Measure

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

  6-months

• Acceptability of Intervention Measure

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

  6-months

• Appropriateness of Intervention Measure

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

  6-months

• Participant Retainment

  Percentage of Participants Retained in Intervention Arm

  6-months

Secondary Outcomes (2)

• PTSD Diagnostic Scale for DSM-5

  Baseline, 3-, 6-, and 9-months

• Patient Reported Outcome Measurement System - Pain Interference

  Baseline, 3-, 6-, and 9-months

Other Outcomes (21)

• PEG

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

• Harvard's Flourishing Measure - Happiness and Life Satisfaction

  Baseline, 3-, 6-, and 9-Months

• Harvard's Flourishing Scale - Meaning and Purpose

  Measurement-based care

Study Arms (2)

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.

Behavioral: CIH Stepped Care

Treatment as Usual

NO INTERVENTION

Treatment as usual at the clinic

Interventions

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.

CIH Stepped Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• David Reed, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Reed, PhD

CONTACT

206-543-3752; davider2@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To mirror a future large-scale trial, the PI/biostatistician/randomizer will remain masked. An unmasked member of the research team will inform individuals to which group they are randomized and will be available to answer questions about assessments if needed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor: School of Medicine, Psychiatry

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: February 18, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD and supporting information will be available after all data has been collected until data is destroyed.
• Access Criteria: Researchers and others whose goal is to advance the science of improving care for those with chronic pain.

Locations

US (1)