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Exercise and Pharmacotherapy for Anxiety in Cardiac Patients - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the effects of exercise and medication on symptoms of worry and stress in adults with coronary heart disease.

What is the Condition Being Studied?

Heart disease with worry, stress, or tension 

Who Can Participate in the Study?

Adults age 40 and older who:
- Have a history of heart disease (e.g., stent, heart attack, bypass graft, or angina)  
- Have symptoms of worry, stress, tension, nervousness, panic, or anxiety  
- Are not currently taking medication to enhance mood  
- Are not currently in a formal exercise program

For more information about who can be in this study, please contact the study team.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

- Have a screening visit that includes answering questionnaires, a physical, and an interview.  
- Have baseline pre-treatment procedures, like an exercise stress test, blood work, and an ultrasound of your blood vessels.  
- Be randomized (like flipping a coin) to one of three 12-week treatment groups:
--- Group 1: Exercise at a local cardiac rehab facility 3 days/week
--- Group 2: Medication pill (escitalopram (Lexapro)) taken daily plus 5 clinic visits
--- Group 3: Placebo (like a sugar pill) taken daily plus 5 clinic visits

- Have post-treatment assessments, the same as you did during the screening visit.  

- Have one follow-up visit 6 months after the study, which involves questionnaires, an interview, and a walk test. 

Study Details

Full Title
Exercise and Pharmacotherapy for Anxiety in Cardiac Patients
Principal Investigator
Clinical Psychologist
Protocol Number
IRB:PRO00064329
NCT:NCT02516332
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698