Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440278
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
Healthy Heart Habits-2
Sponsor:
The Miriam Hospital
Organization:
The Miriam Hospital
Study Overview
Official Title:
Multisite Feasibility of BA-HD An Integrated Depression and Behavioral Risk Factor Reduction Coaching Program Following Acute Coronary Syndrome
Status:
RECRUITING
Status Verified Date:
2024-05
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:
HHH-2
Brief Summary:
Sixty adults who have experienced acute coronary syndrome within the past 2-12 months from three states Rhode Island North Carolina Minnesota will be randomized to either 1 a coaching program for depressed mood and health behavior change Behavioral Activation for Health and Depression BA-HD or 2 Enhanced Usual Care This study will evaluate the feasibility and acceptability of study procedures and BA-HD and establish protocol and measurement harmonization across three sites in preparation for a future multi-site efficacy trial
Detailed Description:
Acute coronary syndrome ACS represents a significant public health burden with the most recent estimates suggesting that over 1 million US adults experience ACS per year As individuals are acutely surviving ACS more often the associated disease burden is increasing for both the healthcare system and the individual living post-ACS
Poor engagement in health behaviors post-ACS contributes to risk for recurrent ACS and mortality Modifiable behavioral contributors include smoking medication non-adherence physical inactivity and poor diet Approximately 20 of post-ACS adults experience depression and depression is associated with worse engagement in critical health behaviors which in turn increases subsequent progression of cardiovascular disease Treatment of depression alone improves but does not eliminate behavioral nonadherence Behavioral Activation is a robust counseling treatment for depression with evidence of improvements in depressive symptoms across varied populations including those with medication conditions BA seeks to improve mood by increasing environmental reinforcement through collaborative values-guided setting of activation goals The goal setting focus and structure of BA allows for seamless integration of health behavior targets and thus offers a potential framework to integrate depression and health behavior treatment BA-HD may be a useful strategy to depression and multiple health behavior improvement post-ACS However this possibility requires further testing
The purpose of this study is to examine the feasibility and acceptability of a multisite pilot randomized controlled trial and test the initial potential effects of the intervention BA-HD on cardiovascular health and depressive symptoms relative to an Enhanced Usual Care control condition Participants will be randomly assigned to either 12 weeks of tele-delivered BA-HD or Enhanced Usual Care ie one session of depression and heart disease education and provision of community mental health resources
Primary endpoints are feasibility of multisite recruitment procedures eg recruitment rates at each site feasibility of intervention and control procedures eg percent of enrolled participants who complete the study study retention eg percent of participants who complete 3 month follow-up and acceptability of intervention content and intervention delivery and control procedures We hypothesize that the intervention content and delivery will be 1 feasible and 2 acceptable We will also examine changes in cardiovascular health depressive symptoms medication adherence affect and quality of life
Poor engagement in health behaviors post-ACS contributes to risk for recurrent ACS and mortality Modifiable behavioral contributors include smoking medication non-adherence physical inactivity and poor diet Approximately 20 of post-ACS adults experience depression and depression is associated with worse engagement in critical health behaviors which in turn increases subsequent progression of cardiovascular disease Treatment of depression alone improves but does not eliminate behavioral nonadherence Behavioral Activation is a robust counseling treatment for depression with evidence of improvements in depressive symptoms across varied populations including those with medication conditions BA seeks to improve mood by increasing environmental reinforcement through collaborative values-guided setting of activation goals The goal setting focus and structure of BA allows for seamless integration of health behavior targets and thus offers a potential framework to integrate depression and health behavior treatment BA-HD may be a useful strategy to depression and multiple health behavior improvement post-ACS However this possibility requires further testing
The purpose of this study is to examine the feasibility and acceptability of a multisite pilot randomized controlled trial and test the initial potential effects of the intervention BA-HD on cardiovascular health and depressive symptoms relative to an Enhanced Usual Care control condition Participants will be randomly assigned to either 12 weeks of tele-delivered BA-HD or Enhanced Usual Care ie one session of depression and heart disease education and provision of community mental health resources
Primary endpoints are feasibility of multisite recruitment procedures eg recruitment rates at each site feasibility of intervention and control procedures eg percent of enrolled participants who complete the study study retention eg percent of participants who complete 3 month follow-up and acceptability of intervention content and intervention delivery and control procedures We hypothesize that the intervention content and delivery will be 1 feasible and 2 acceptable We will also examine changes in cardiovascular health depressive symptoms medication adherence affect and quality of life
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