CIH Stepped Care for Co-occurring Chronic Pain and PTSD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CIH Stepped Care.
- Who it may be relevant to
- Registry conditions: Chronic Pain, Posttraumatic Stress Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Randomized Controlled Trial of CIH Stepped Care for Co-occurring Chronic Pain and PTSD
Overview
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]
- Acceptability of Intervention Measure [Time frame: 6-months]
- Appropriateness of Intervention Measure [Time frame: 6-months]
- Participant Retainment [Time frame: 6-months]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Washington — Seattle
Identifiers
NCT: NCT06219408 · STUDY00015530 · R00AT012054