CIH Stepped Care for Co-occurring Chronic Pain and PTSD

Официальное название

A Pilot Randomized Controlled Trial of CIH Stepped Care for Co-occurring Chronic Pain and PTSD

Обзор

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).

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Feasibility of Intervention Measure [Срок оценки: 6-months]
• Acceptability of Intervention Measure [Срок оценки: 6-months]
• Appropriateness of Intervention Measure [Срок оценки: 6-months]
• Participant Retainment [Срок оценки: 6-months]

Вторичные конечные точки (2)

• PTSD Diagnostic Scale for DSM-5 [Срок оценки: Baseline, 3-, 6-, and 9-months]
• Patient Reported Outcome Measurement System - Pain Interference [Срок оценки: Baseline, 3-, 6-, and 9-months]

Критерии участия

Критерии включения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Washington — Seattle

Идентификаторы

NCT: NCT06219408 · STUDY00015530 · R00AT012054

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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