Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03629158
Status:
COMPLETED
Last Update Posted:
2019-08-02
First Post:
2018-07-31
Brief Title:
Brief Behavioral Health Intervention Program for Patients With Stable Coronary Artery Disease
Sponsor:
University of Central Florida
Organization:
University of Central Florida
Study Overview
Official Title:
Brief Behavioral Health Intervention Program for Patients With Stable Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2019-07
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:
None
Brief Summary:
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
Detailed Description:
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
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
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