Equity Using Interventions for Pain and Depression (EQUIPD) - Phase 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months
研究概览
简要总结
This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This pilot randomized controlled trial (RCT) is part of phase 1 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (NPTs).
This 2-arm pilot trial randomized 30 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system. After the baseline assessment, patients randomized to the intervention were asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions used Motivational Interviewing principles to foster openness to NPTs and self-efficacy by helping patients identify their goals and priorities, understand their NPT options, prepare them to discuss and choose options with their primary care providers (PCPs), and reinforce these choices to foster maintenance of these changes. DA contents were integrated into these sessions, which facilitated discussion of these options with their PCP. The first 3 sessions ideally took place prior to the patient's next scheduled PCP visit; the final session occurred after this visit. Assessments were conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months.
Patients randomized to the wait-list control group received usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they were given the DA and offered a 20-minute coaching session to walk them through it (patients could decline the coaching session).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients must:
- •have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for ≥3 months,
- •have at least moderate pain intensity and interference with function, defined by a score ≥4 (possible range: 0-10) on the Pain, Enjoyment of Life and General Activity scale (PEG), a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity,
- •have at least mild depression, defined as PHQ-8 score ≥5,
- •identify as Black or African American,
- •have consistent access to a telephone,
- •indicate openness to new pain treatments, and
- •have a scheduled appointment with their PCP in the next approximate 2-4 months
排除标准
- •Patients are excluded:
- •if previously participated in the PI's past pilot study (IRB #12885) or participation as a Patient Engagement Panel member for this project,
- •if medical records indicate severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure), or
- •if the eligibility screener reveals (1) active suicidal ideation, or (2) severe hearing/speech or cognitive impairment.
研究组 & 干预措施
Coaching and Decision Aid
Individual coaching sessions and Decision Aid
干预措施: Coaching and Decision Aid (Behavioral)
Control
Wait-list control group
结局指标
主要结局
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months
时间窗: 3 months
The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 6 Months
时间窗: 6 months
The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
次要结局
- Change From Baseline Altarum Consumer Engagement (ACE) Measure at 6 Months(6 months)
- Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 Months(3 months)
- Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 Months(6 months)
- Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 Months(3 months)
- Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 Months(6 months)
- Change From Baseline CollaboRATE at 3 Months(3 months)
- Change From Baseline CollaboRATE at 6 Months(6 months)
- Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 3 Months(3 months)
- Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 6 Months(6 months)
- Change From Baseline Patient Health Questionnaire (PHQ)-8 at 3 Months(3 months)
- Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 Months(6 months)
- Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 Months(3 months)
- Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 Months(6 months)
- Change From Baseline Pain Catastrophizing Scale at 3 Months(3 months)
- Change From Baseline Pain Catastrophizing Scale at 6 Months(6 months)
- Change From Baseline Altarum Consumer Engagement (ACE) Measure at 3 Months(3 months)
研究者
Marianne S. Matthias
Professor
Indiana University