Pilot Study of Depression and Pain Perseverance Through Empowered Recovery (DAPPER) Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
研究概览
简要总结
African American women who are 50 years of age and older with depressive symptoms, pain and difficulty with mobility will participate in the DAPPER intervention study that includes 8 nurse visits in participants' homes to help participants with participants' pain and mood.
详细描述
The proposed intervention is called Depression and Pain Perseverance through Empowered Recovery (DAPPER). The investigators are adapting the Get Busy Get Better intervention by adding components (e.g. nurse visits and person directed goals) from the CAPABLE study for this intervention. The investigator will further develop the intervention through this two-phase pilot test. The aims of this pilot project are to 1) test the Depression and Pain Perseverance through Empowered Recovery (DAPPER) program for feasibility and acceptability. Specifically, the investigators will test the effect size of DAPPER on pain and depressive symptoms from baseline to 12 weeks (compare intervention to wait list control group) and then at 24 weeks to compare the intervention group to wait list control group once again. 2) estimate preliminary effect sizes for DAPPER in reduction pain and depressive symptoms, 3) measure effect sizes and feasibility of measuring cytokines and heart rate variability (HRV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The statistician will be responsible for randomization and the investigator and study team will not have knowledge if participants are assigned to intervention group or wait list control group.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Self-report pain >3 out of a 0 -10 scale that has lasted longer than 3 months and keeps subjects from doing at least one activity that subjects would like to do
- •Self-Identify as African American/Black female
- •Live in a community dwelling
- •Score a 5 or higher on the PHQ-9 (depression measure) at least two times during a two week period (screening call and then at first data collection visit)
- •Must be pre-frail (one or two criteria on frailty phenotype) or frail (three or more of the criteria on frailty phenotype)
- •One ADL or IADL limitation
排除标准
- •Hospitalized > 3 times in the last year
- •Participating in physical therapy
- •Have a terminal diagnosis (<1 year expected survival)
- •> moderate intellectual impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMSQ)
- •Unable to speak or understand English
结局指标
主要结局
Pain Intensity as Assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)
时间窗: Baseline and 12 weeks
The PROMIS Intensity is used to measure pain intensity on a scale of 0-10. Higher scores indicate more pain intensity.
Depressive Symptoms as Assessed by the Patient Health Questionnaire 9 (PHQ-9)
时间窗: Baseline and 12 weeks
The Patient Health Questionnaire 9 (PHQ-9) includes 9 questions related to the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic criteria for major depression. The PHQ-9 scores range from 0-27. Higher scores indicate more depressive symptoms.
次要结局
- Interleukin (IL)-6 in Saliva (pg/ml)(Baseline and 12 weeks)
- Interleukin (IL)-8 in Saliva (pg/ml)(Pre intervention , Post intervention 12 weeks for Intervention arm)
- Interleukin (IL)-1 Beta in Saliva (pg/ml)(Baseline and Post intervention 12 weeks for intervention arm. Baseline for wait list control.)
- Tumor Necrosis Factor (TNF)-Alpha in Saliva (pg/ml)(Baseline and post intervention (12 weeks ) for intervention arm. Baseline only (wait list control arm))