CIH Stepped Care for Co-occurring Chronic Pain and PTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older
A clinic employee and/or trainee
Aged 18 years or older
English-speaking
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
CIH Stepped Care
BehavioralCIH 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: CIH Stepped CareExperimental treatment 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility of Intervention Measure
Feasibility of intervention; 1-5; higher scores indicate greater feasibility
Time frame
6-months2
Acceptability of Intervention Measure
Acceptability of Intervention; 1-5; higher scores indicate greater acceptability
Time frame
6-months3
Appropriateness of Intervention Measure
Appropriateness of Intervention; 1-5; higher scores indicate greater appropriateness
Time frame
6-months4
Participant Retainment
Percentage of Participants Retained in Intervention Arm
Time frame
6-monthsSecondary outcomes
1
PTSD Diagnostic Scale for DSM-5
PTSD symptoms; 0-80; higher scores indicate more severe PTSD symptoms
Time frame
Baseline, 3-, 6-, and 9-months2
Patient Reported Outcome Measurement System - Pain Interference
Pain interference; 0-100; higher scores indicate worse pain interference
Time frame
Baseline, 3-, 6-, and 9-monthsOther outcomes
1
PEG
Pain severity and interference; 0-10; higher scores indicate more pain severity and interference
Time frame
Measurement-based care (every 2 weeks for those in CIH Stepped Care)2
Harvard's Flourishing Measure - Happiness and Life Satisfaction
Happiness and Life Satisfaction; 0-10; higher scores indicate greater happiness and life satisfaction
Time frame
Baseline, 3-, 6-, and 9-Months3
Harvard's Flourishing Scale - Meaning and Purpose
Meaning and Purpose (every 2 weeks for those in CIH Stepped Care); 0-10; higher scores indicate greater meaning and purpose
Time frame
Measurement-based care4
Emotion Regulation Questionnaire-Short Form
Cognitive re-appraisal; 3-21; higher scores indicate greater cognitive re-appraisal
Time frame
Baseline, 3-, 6-, and 9-monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov