Chronic Pain, Posttraumatic Stress Disorder
Conditions
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).
Interventions
BEHAVIORALCIH 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.
Sponsors
University of Washington
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Measure | 6-months | Feasibility of intervention; 1-5; higher scores indicate greater feasibility |
| Acceptability of Intervention Measure | 6-months | Acceptability of Intervention; 1-5; higher scores indicate greater acceptability |
| Appropriateness of Intervention Measure | 6-months | Appropriateness of Intervention; 1-5; higher scores indicate greater appropriateness |
| Participant Retainment | 6-months | Percentage of Participants Retained in Intervention Arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Diagnostic Scale for DSM-5 | Baseline, 3-, 6-, and 9-months | PTSD symptoms; 0-80; higher scores indicate more severe PTSD symptoms |
| Patient Reported Outcome Measurement System - Pain Interference | Baseline, 3-, 6-, and 9-months | Pain interference; 0-100; higher scores indicate worse pain interference |
Countries
United States
Contacts
CONTACTDavid Reed, PhD
PRINCIPAL_INVESTIGATORDavid Reed, PhD
University of Washington
Outcome results
None listed