CIH Stepped Care for Co-occurring Chronic Pain and PTSD

N/ARecruitingNCT06219408

University of Washington60 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Pain Posttraumatic Stress Disorder

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 exclusion criteria for clinic employees. Patients who meet any of the following criteria will be excluded from participation in this study: 1. In current treatment for chronic pain and/or PTSD at their respective clinic 2. Past 2-week suicidal intention at screening 3. Severe cognitive impairment preventing individual from participating

Outcomes

Primary Outcomes

Feasibility of Intervention Measure

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

Time frame: 6-months

Acceptability of Intervention Measure

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

Time frame: 6-months

Appropriateness of Intervention Measure

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

Time frame: 6-months

Participant Retainment

Percentage of Participants Retained in Intervention Arm

Time frame: 6-months

Secondary Outcomes

PTSD Diagnostic Scale for DSM-5

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

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

Patient Reported Outcome Measurement System - Pain Interference

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

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

CIH Stepped Care for Co-occurring Chronic Pain and PTSD

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts