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| ID | Type | Description | Link |
|---|---|---|---|
| R00AT012054 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Treatment as Usual | No Intervention | Treatment as usual at the clinic |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Diagnostic Scale for DSM-5 | PTSD symptoms; 0-80; higher scores indicate more severe PTSD symptoms | Baseline, 3-, 6-, and 9-months |
| Patient Reported Outcome Measurement System - Pain Interference |
| Measure | Description | Time Frame |
|---|---|---|
| PEG | Pain severity and interference; 0-10; higher scores indicate more pain severity and interference | Measurement-based care (every 2 weeks for those in CIH Stepped Care) |
| Harvard's Flourishing Measure - Happiness and Life Satisfaction |
Inclusion Criteria
In order to be eligible to participate in this study, clinic employees must meet all of the following criteria:
In order to be eligible to participate in this study, patients must meet all of the following criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Reed, PhD | Contact | 206-543-3752 | davider2@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Reed, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
IPD will be de-identified and approved by the PI.
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IPD and supporting information will be available after all data has been collected until data is destroyed.
Researchers and others whose goal is to advance the science of improving care for those with chronic pain.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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Pain interference; 0-100; higher scores indicate worse pain interference
| Baseline, 3-, 6-, and 9-months |
Happiness and Life Satisfaction; 0-10; higher scores indicate greater happiness and life satisfaction
| Baseline, 3-, 6-, and 9-Months |
| 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 | Measurement-based care |
| Emotion Regulation Questionnaire-Short Form | Cognitive re-appraisal; 3-21; higher scores indicate greater cognitive re-appraisal | Baseline, 3-, 6-, and 9-months |
| Metacognitive Processes of Decentering Scale | Decentering; 0-10; higher scores indicate higher decentering | Baseline, 3-, 6-, and 9-months |
| Meaning in Life Questionnaire | Meaning in Life; 1-7; higher scores indicate more meaning in life | Baseline, 3-, 6-, and 9-months |
| Existential Phenomenological Questionnaire - Short Form | Existential Anxiety; 1-5; higher scores indicate more existential anxiety | Baseline, 3-, 6-, and 9-months |
| Five Facet Mindfulness Questionnaire | Mindfulness; 24-120; higher scores indicate more mindfulness | Baseline, 3-, 6-, and 9-months |
| Columbia-Suicide Severity Rating Scale - Self-Report | Suicidality; 6 items; risk levels of high, moderate, low/no risk are determined | 3-, 6-, and 9-months |
| GAD-7 | Anxiety; 0-21; higher scores indicate more severe anxiety symptoms | Baseline, 3-, 6-, and 9-Months |
| PHQ-9 | Depression; 0-27; higher scores indicate more severe depression symptoms | Baseline, 3-, 6-, and 9-Months |
| PROMIS-Physical Health | Physical Health; 0-100 T-scores; higher scores indicate greater physical health function | Baseline, 3-, 6-, and 9-Months |
| Working Alliance Inventory-Short Revised-Therapist | Therapeutic Alliance; 1-7; higher scores indicate greater working patient-provider therapeutic alliance | 3- and 6-months |
| Reason for Dropout | 1-item on why participant discontinued study | 6-months |
| Fidelity of CIH Stepped Care | Treatment fidelity; percentage of items completed; greater percentage indicates higher fidelity | 6-months |
| PTSD Checklist for DSM-5 | PTSD Symptoms; 0-80; higher scores indicate higher PTSD symptom severity | Measurement-based care (every 2 weeks for those in CIH Stepped Care) |
| Adherence | Adherence (defined as completing over 50% of the measurement-based care assessments that occur every 2 weeks and completing participant-health coach measurement-based care contacts, where, for instance, treatment options would be discussed) | 6-months |
| Medication use | Medication use (name, dose, and frequency) | Baseline, 3-, 6-, and 9-months |
| Healthcare use | Healthcare use; frequency of different healthcare services used (e.g., primary care visits) | Baseline, 3-, 6-, and 9-months |
| Treatment Change | 1-item asking patients in the CIH Stepped Care condition whether they would like to change treatments | Measurement-based care (every 2 weeks for those in CIH Stepped Care) |
| Working Alliance Inventory-Short Revised-Client | Therapeutic Alliance; 1-7; higher scores indicate greater working patient-provider therapeutic alliance | 3- and 6-months |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |