RFCBT I - Proof of Concept Study/Single Subject Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Response Style Questionnaire
研究概览
简要总结
Many people know that a poor diet, exercise, smoking, and alcohol use cause heart disease. However, a less known factor that increases the risk of heart disease is depression. In addition, heart disease can also make depression worse. Almost half of American adults have some form of heart disease. Patients with low income are at an even greater risk. The circular relation between depression and heart disease raises the question of whether or not there are factors that lead to both. Attacking a factor that affects both depression and heart disease could help prevent them both. One such factor is rumination which is when someone tends to have repeated negative thoughts that loop without end. This loop in turn tears and wears down the body over time, making the person be at risk for heart disease and depression. Rumination-Focused Cognitive Behavioral Therapy (RFCBT) is a tool that targets rumination and, by doing so, reduces the risk for depression. While research has shown RFCBT helps to reduce or stop the loop that leads to depression, this project will further look at the effect of RFCBT on measures of heart health persons with low income.
详细描述
Objectives Objective #1: Determine whether RFCBT will impact blood pressure as a biomarker of cardiovascular health. The investigators hypothesize that RFCBT will lead to an improvement in blood pressure.
Objective #2: Determine whether RFCBT will impact stress biomarkers of cardiovascular health. The investigators hypothesize that RF-CBT will lead to an improvement of salivary cortisol.
Objective #3: Determine whether RFCBT will impact inflammatory biomarkers of cardiovascular health. The investigators hypothesize that RF-CBT will lead to an improvement of salivary C-Reactive Protein (h-CRP), interleukin (IL-6), and tumor necrosis factor-alpha (TNF-α).
Objective #4: Determine the acceptability of RFCBT for individuals with low income. While the investigators cannot predict the themes that will be generated, the information will have implications for the use of RFCBT with individuals with low income.
Study Design/Methodology The investigators will use a multiple baseline design - a type of Single Case Experimental Design (SCED) and collect survey, interview, and biological (blood pressure & saliva) data. Because of the study design, all participants will receive Rumination-Focused Cognitive Behavioral Training (RFCBT); the study is not blinded, and no non-intervention control group is necessary. As participants will be selected non-randomly, they will be randomly assigned to a group or in other words after how many weeks of baseline phase they will perceive RFCBT using the random number generator in the statistics package R. That is, 1/3rd of the participants will participate in 5 baseline waves of data collection, each one week apart, before starting RFCBT, another 1/3rd of participants will participate in 6 baseline waves before starting RFCBT, and the final 1/3rd of participants will participate in 6 baseline waves before starting RFCBT. Thus, all participants will participate in 5 to 7 weekly baseline waves. Next, each participant will participate with their trainer in up to 18 50-minute meetings of RFCBT. In this time, each participant will participate in 6 to 9 waves of training data collection (one wave of data collection every 2 RFCBT meetings). After completion of the training, each participant will be followed for another 10 weeks during which they participate in 5 waves of follow-up data collection (one wave of data collection every 2 weeks). Thus, each participant participates in 28 to 36 weeks in the study and takes part in 16 to 21 waves of data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is a Single subject design study. Thus, as all participants receive the intervention, there is no masking possible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •RSQ-Brooding score: >= 11
- •PHQ-9 score: 10-20
- •SBP: >= 120 and/or DBP: >= 80)
- •fluent in English
排除标准
- •None besides the described inclusion criteria
结局指标
主要结局
Response Style Questionnaire
时间窗: 33 weeks after baseline 1
sadness rumination, Score range: 5-20, higher score = more rumination
systolic blood pressure measures
时间窗: 33 weeks after baseline 1
systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
diastolic blood pressure measures
时间窗: 33 weeks after baseline 1
diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
Patient Health Questionnaire-9
时间窗: 33 weeks after baseline 1
depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
次要结局
未报告次要终点
研究者
Patrick Possel
Professor
University of Louisville