Testing an Intervention to Reduce Pain and Depression Among Older Women With Physical Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in Pain Interference as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)
研究概览
简要总结
Chronic pain and depression or low mood are often experience by women who age with or into disabilities. Due to various factors women with disabilities often experience this cycle of pain and depression. Both of these conditions can be debilitating and lead to declines in health. Treating these conditions simultaneously, particularly , in older adults can be complicated due to side effects, risks of poor access to pain management and mental health care , and complications from other co occuring conditions. In order to address this cycle in older women with disabilities the investigators are testing the Women in Pain Reduction through Improved Mood and Empowerment (PRIME) study. The PRIME intervention includes four in person visits by a nurse to the women's homes where the participants set goals regarding pain and depression and the nurse helps the participants strategize ways to meet these goals. The second component of the study will be eight group sessions virtually with other participants in the study. The group sessions will be led by a clinical psychologist who will engage in Acceptance Commitment Therapy with the women.
详细描述
Chronic pain and depression frequently co-occur among older women with disabilities, and each can exacerbate the other in a worsening cycle. This co-occurrence may be due, in part, to pain and depression sharing biologic etiologies such as inflammation. Beyond each individual category of risk, the intersection of age, sex, and disability place older women with disabilities at even higher risk of having co-occurring pain and depression.There are several effective multi-component behavioral interventions for either pain or depression, but not both outcomes in combination, and none were designed to integrate social determinants of health to address the inequities inherent in being an older woman with disabilities. Addressing these two conditions in this population warrants multicomponent interventions that are appropriate for and inclusive of all older women with disabilities. The proposed study is to apply self-regulation theory to refine and further test the feasibility of a tailored behavioral activation intervention, older women with disabilities in Pain Reduction through Improved Mood and Empowerment (PRIME) Study Aim 1: Leveraging the investigators previous research, the investigators will enroll 15-30 community dwelling women , ages 50 and over, with physical disabilities , living in Maryland who have pain and depression in the Women in PRIME clinical trial.
Aim 2: The investigators will determine a) feasibility and acceptability of the intervention and b) if strategies and evaluation techniques are appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The data collectors, interventionists, and investigator will be masked to which group participants belong to.
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-reported pain >4 out of a 0-10 scale that has lasted longer than 3 months and prohibits at least one valued or daily activity,
- •physical disability based on the 2008 American Community Survey. The survey includes one question about disability in the following categories: sensory, physical, self-care, ability to go outside of the home, and independent living difficulty. Candidates who report having mobility disabilities will be considered for the study,
- •non-institutionalized and living in Maryland, and
- •score a 5 or higher on the PHQ9 (depression measure) at least two times during a two week period (screening call and then at first data collection visit via video)
- •50 years of age and older, 6) female
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), 81 and
- •unable to understand or speak English. We will exclude anyone with more than three hospitalizations and/or have a terminal diagnosis because of the acuity of their conditions which may limit the effectiveness of the intervention. Physical therapy may impact the outcomes of the intervention and having impaired cognition may make it difficult for participants to engage in the nurse visits, set goals and participate in the ACT sessions.
研究组 & 干预措施
Wait List Control Group
This group will be randomized to wait list control. They will serve as a control for the intervention at time points 1 and 2. However after a 2-3 month period they will receive the intervention.
干预措施: PRIME Intervention (Behavioral)
Intervention Group
Individuals randomized to this group will start the intervention immediately and have outcomes measured at three time points.
干预措施: PRIME Intervention (Behavioral)
结局指标
主要结局
Change in Pain Interference as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)
时间窗: Baseline, 12 weeks, 24 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference is a 6 question measure with a range of 6-30 with a higher score indicating increased pain interference.
Change in Pain Behavior as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)Pain behavior measure
时间窗: Baseline, 12 weeks, 24 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference is a 20 question measure with a range of 20-100 with a higher score indicating increased pain behaviors
Change in Depression as assessed by the Patient Health Questionnaire 9 (PHQ9)
时间窗: Baseline, 12 weeks, 24 weeks
The Patient Health Questionnaire 9 (PHQ9) measures depressive symptoms. The score range is 0-27 with a higher score indicating more severe depression.
Change in depression as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 57
时间窗: Baseline, 12 weeks, 24 weeks
The Patient Reported Outcomes Measurement System (PROMIS)57 the Patient Reported Outcomes Measurement Information System (PROMIS) 57, which is includes an 8-item instrument that can be used to measure self-reported negative mood, view of self, and somatic symptoms. The score range for PROMIS 57 is 8-40. Higher scores indicate more depressive symptoms
Change in Pain Intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity measure
时间窗: Baseline, 12 weeks, 24 weeks
Pain Intensity will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity measure. PROMIS Pain Intensity is a 3 question measure with a range of 3-15 with a higher score indicating increased pain intensity.
Pain Intensity as Assessed by the Patient-Reported Outcomes Measurement Information System Pain Intensity Measure
时间窗: Baseline and 12 weeks
Pain Intensity was measured by the Patient-Reported Outcomes Measurement Information System . Pain intensity measure. Patient-Reported Outcomes Measurement Information System . Survey uses a standardized T-score metric based on a mean of 50 and a standard deviation of 10. Higher score worse pain.
Pain Interference as Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)
时间窗: Baseline and 12 weeks.
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference is a 6 question measure with a range of 0-100 with a higher score indicating increased pain interference.
Pain Behavior as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)Pain Behavior Measure
时间窗: Baseline and 12 weeks.
Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference is a 20 question measure with a range of 20-100 with a higher score indicating increased pain behaviors
Depression as Assessed by the Patient Health Questionnaire 9 (PHQ9)
时间窗: Baseline and 12 weeks.
The Patient Health Questionnaire 9 (PHQ9) measures depressive symptoms. The score range is 0-27 with a higher score indicating more severe depression.
Depression as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 57
时间窗: Baseline and 12 weeks
The Patient Reported Outcomes Measurement System (PROMIS)57 the Patient Reported Outcomes Measurement Information System (PROMIS) 57, which is includes an 8-item instrument that can be used to measure self-reported negative mood, view of self, and somatic symptoms. The score range for PROMIS 57 is 8-40. Higher scores indicate more depressive symptoms, which is a worse outcome.
次要结局
- Change in Psychological Flexibility as assessed by the Psychological Flexibility in Pain Instrument(Baseline, 12 weeks, 24 weeks)
- Communication with Health Care Providers- Patient Reaction Assessment(Baseline and 12 weeks)
- Change in Interleukin-6 (IL-6), Interleukin-8 (IL-8), and(Baseline and 12 weeks)
- Change in Goal Attainment as assessed by self report(At baseline and at 12 weeks)
- Change in Comorbidities as assessed by the Charlson Comorbidity Index (CCI)(Baseline and 12 weeks)
- Change in Sleep Disturbance as assessed by the 4 item PROMIS sleep disturbance measure(Baseline and 12 weeks)
- Psychological Flexibility as Assessed by the Psychological Flexibility in Pain Instrument(Baseline and 12 weeks. Baseline are pre intervention scores and 12 weeks are post intervention scores.)
- Percentage of Goals Attained as Assessed by Self Report(12 weeks)
- Comorbidities as Assessed by the Charlson Comorbidity Index (CCI)(Baseline)
- Change in Sleep Disturbance as Assessed by the 4 Item PROMIS Sleep Disturbance Measure(Baseline and 12 weeks)
- Communication With Health Care Providers- Patient Reaction Assessment(Baseline and 12 weeks)