跳至主要内容
临床试验/NCT04158219
NCT04158219已完成1 期

Development of an Integrated Depression and Behavioral Risk Factor Reduction Intervention for Secondary Prevention Following Acute Coronary Syndrome

Hennepin Healthcare Research Institute1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年11月15日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
8
试验地点
1
主要终点
Acceptability Measured by the Client Satisfaction Questionnaire

研究概览

简要总结

Approximately 350,000 Acute Coronary Syndrome (ACS) patients experience significant depression symptoms each year in the US. Post-ACS depressed mood interferes with patients making necessary changes to behavioral risk factors (e.g., smoking cessation) and predicts poor medical outcomes. The proposed study will develop an integrated depression and behavioral risk factor reduction intervention for secondary prevention post-ACS through an open trial of 20 patients.

详细描述

Depression predicts high rates of morbidity/mortality among acute coronary syndrome (ACS) patients. Part of this relationship is explained by a poor profile of behavioral risk factors (i.e., smoking,physical activity, medication adherence, diet). An integrated treatment targeting both depressed mood and multiple behavioral risk factors could be highly effective in reducing post-ACS mortality. Behavioral Activation for depression may be an ideal counseling treatment for this since it has recently shown promise for facilitating behavioral risk factor changes in ACS patients with depression (K23HL107391). The current study adapts this manual targeting post-ACS depressed mood and smoking cessation to target depression and multiple behavioral risk factors post-ACS. This study will be an open trial (N=20) to test the feasibility and acceptability of our procedures and obtain initial indications of efficacy. This study hypothesizes that 1) the BA-HD manual and study procedures will be feasible and acceptable to post-ACS patients with depressed mood as measured by self-report, recruitment/retention rate, and post- treatment qualitative interviews and 2) that participants will experience clinically significant improvements in depressed mood and behavioral risk factor profile. The long-term goal of this research is to improve long-term survival rates following ACS.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ACS diagnosis (diagnosis of unstable angina, ST and non-ST elevation myocardial infarction) documented in medical record in the preceding 2-12 months
  • •Current diagnosis of depression documented in medical record, OR clinically administered PHQ-9 score of 10 or greater documented in the medical record in the preceding 12 months, OR CES-D score greater than or equal to 10
  • •current non-adherence to 1 or more of 4 more behavioral risk factors
  • •willing to make immediate changes to one or more of the relevant behavioral risk factors
  • •age of 18-75
  • •lives within 1.5 hours of Hennepin Healthcare
  • •fluent in English.

排除标准

  • •Limited mental competency (as indicated in medical chart)
  • •presence of current exacerbation of psychosis/serious mental illness or suicidality
  • •in hospice care
  • •currently attending regular counseling targeting depression or any health behavior change
  • •currently attending a cardiac rehabilitation program (those excluded for being in rehabilitation will be re-contacted after completion)

研究组 & 干预措施

Treatment

Experimental

Behavioral activation for health and depression (BA-HD)

干预措施: Behavioral activation for health and depression (BA-HD) (Behavioral)

结局指标

主要结局

Acceptability Measured by the Client Satisfaction Questionnaire

时间窗: At 12 weeks

This will be assessed at the end of the intervention using the 8-item Client Satisfaction Questionnaire. score range 8-32 with higher score indicating greater satisfaction.

Treatment Engagement Measured by Sessions Attended

时间窗: At 12 weeks

Throughout the study we will measure engagement by tracking attendance of treatment sessions.

次要结局

  • Depression Symptoms as Measured by PHQ-9 (Patient Health Questionnaire-9)(At 12 weeks)
  • Composite Behavioral Risk Factor Adherence MOS (Medical Outcomes Study Patient Adherence Questionnaire)(At 12 weeks)
  • Study Retention Measured by the Number of Participants Who Complete the Follow-up Assessments(At 12 weeks)
  • Depression Symptoms as Measured by CES-D 10 (Center for Epidemiological Studies Depression Scale Revised)(At 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Busch

Sr. Clinical Psychologist, Associate Professor

Hennepin Healthcare Research Institute

研究点 (1)

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