Brief Behavioral Health Intervention Program for Patients With Stable Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Self-efficacy for managing coronary artery disease
研究概览
简要总结
The purpose of this study is to examine the effectiveness of a lifestyle intervention for patients living with stable coronary artery disease (CAD). One group will receive the the intervention, and the other will receive treatment as usual (TAU). The investigators hypothesize that, compared to the TAU group, participants receiving the intervention will 1) experience greater confidence in managing their cardiac disease, as indicated by perceived self-efficacy and illness perceptions; 2) experience greater psychological adjustment as indicated by depressive, anxious, and demoralization symptoms; 3) experience greater engagement in health behaviors including healthy eating and physical activity.
详细描述
Participants will be randomly assigned to one of two research groups: the intervention group (IG) and the treatment as usual (TAU) group. The IG will receive the Cardiac Lifestyle Intervention for Maintaining healthy Behaviors ("CLIMB"). CLIMB is a 3-session (2-week) intervention. One session includes health behavior feedback, and patient selection of relevant lifestyle modules based on values clarification. In the remaining two sessions, participants will complete two of five elective lifestyle modules: Healthy Eating, Physical Activity, Reducing Stress and Worry, Mood Management, and Smoking Cessation Education. Intervention components include information provision, goal setting, problem solving, and elements of cognitive behavioral therapy.
Participants in the IG will complete a Baseline assessment, three intervention sessions, a 30-day follow-up, and a 3-month follow-up. Baseline and Session 1 will take place on the same day. Sessions 1, 2, and 3 will be spaced approximately one week apart from one another (1 week in-between Sessions 1 and 2, and 1 week in-between Sessions 2 and 3). The 30-day follow-up will occur approximately 30-days after Session 3. The 3-month follow-up will occur approximately 3 months after Session 3. Assessment measures will be filled out at Baseline, at Post-treatment (end of Session 3), at 30-day follow-up, and at 3-month follow-up. The TAU group will fill out assessment measures at comparable time points, with the exception that there will be no 3-month follow-up. After completing their 30-day follow-up measures, TAU members may elect to receive the CLIMB intervention.
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
- None
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CAD as indicated by history of at least one myocardial infarction, at least one coronary artery bypass graft surgery, at least one coronary stent, and/or at least one coronary vessel with stenosis greater than or equal to 70%.
- •Stable status as indicated by no myocardial infarctions, unstable angina, or other acute coronary syndromes within the past 3 months, no coronary revascularizations within the past 3 months, and no planned revascularizations.
排除标准
- •Age < 30 years or > 79 years
- •Cognitive impairment as indicated by diagnosis in medical chart
- •Psychotic symptoms as indicated by diagnosis in medical chart
- •Any documented non-skin malignancy, malignant melanoma, or advanced kidney disease (indicated by stage 4 or 5 or on dialysis)
- •Ejection fraction < 30%
- •Physician determination of inappropriateness for study, due to anticipated life expectancy of <1 year, presence of a survival limiting or uncontrolled illness, and/or hemodynamically important valvular disease.
- •Women who are pregnant or breast feeding
- •Non-English-speaking
- •Participation in another clinical trial concurrently or within 30 days before screening
- •Psychological safety concerns, including plans to harm oneself within the past two months and/or suicide attempt within the past year
研究组 & 干预措施
CLIMB intervention
The intervention group will receive the Cardiac Lifestyle Intervention for Maintaining healthy Behaviors ("CLIMB") intervention. Participants will participate in a 3-session, one-on-one intervention that takes place over the course of two weeks.
干预措施: CLIMB intervention (Behavioral)
Treatment as usual (TAU)
The TAU group will continue to receive their regular medical care.
结局指标
主要结局
Self-efficacy for managing coronary artery disease
时间窗: 30-day follow-up
Participants will complete the Self-Efficacy for Managing Chronic Disease Scale-6 (SEMCD-6) to assess self-efficacy in managing coronary artery disease. Scale scores range from 6 (minimum) to 60 (maximum), with higher scores indicating greater self-efficacy in managing chronic disease (i.e., a better outcome).
Participant-reported depressive symptoms
时间窗: 30-day follow-up
The Patient Health Questionnaire-9 (PHQ-9) will be administered to assess depressive symptoms. Scale scores range from 0 (minimum) to 27 (maximum) with higher scores indicating elevated depressive symptoms (i.e., a worse outcome).
Illness perceptions
时间窗: 30-day follow-up
Participants will complete the Brief Illness Perception Questionnaire (B-IPQ) as a measure of how threatening they perceive their coronary artery disease to be. Scale scores range from 0 (minimum) to 80 (maximum), with higher scores indicating more threatening illness perceptions (i.e., a worse outcome).
Participant-reported anxiety symptoms
时间窗: 30-day follow-up
The Generalized Anxiety Disorder-7 (GAD-7) will be administered to assess anxious symptoms. Scale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating elevated levels of anxiety symptoms (i.e., a worse outcome).
次要结局
- Confidence in resisting over-eating and unhealthy foods (i.e., Diet self-efficacy)(2-weeks/post-treatment, 30-day follow-up)
- Participant-reported symptoms of demoralization(2-weeks/post-treatment, 30-day follow-up)
- Dietary patterns as measured using the brief dietary assessment and intervention tool: the Starting the Conversation (STC) questionnaire.(2-weeks/post-treatment, 30-day follow-up)
- Number of cigarettes smoked per week over the past two weeks(2-weeks/post-treatment, 30-day follow-up)
- Physical activity patterns(2-weeks/post-treatment, 30-day follow-up)
- Confidence in exercising consistently (i.e., Exercise self-efficacy)(2-weeks/post-treatment, 30-day follow-up)
研究者
Chelsea Wiener
MS
University of Central Florida