Ignite Creation Date:
2024-05-06 @ 1:54 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04158219
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2019-11-06
Brief Title:
Healthy Heart Habits
Sponsor:
Hennepin Healthcare Research Institute
Organization:
Hennepin Healthcare Research Institute
Study Overview
Official Title:
Development of an Integrated Depression and Behavioral Risk Factor Reduction Intervention for Secondary Prevention Following Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
H3
Brief Summary:
Approximately 350000 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 eg 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
Detailed Description:
Depression predicts high rates of morbiditymortality among acute coronary syndrome ACS patients Part of this relationship is explained by a poor profile of behavioral risk factors ie smokingphysical 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 N20 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 recruitmentretention 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None