Treatment of anxiety in patients with coronary heart disease: Rationale and design of the UNderstanding the benefits of exercise and escitalopram in anxious patients WIth coroNary heart Disease (UNWIND) randomized clinical trial.
BACKGROUND
Anxiety is highly prevalent among patients with coronary heart disease (CHD), and there is growing evidence that high levels of anxiety are associated with worse prognosis. However, few studies have evaluated the efficacy of treating anxiety in CHD patients for reducing symptoms and improving clinical outcomes. Exercise and selective serotonin reuptake inhibitors have been shown to be effective in treating patients with depression, but have not been studied in cardiac patients with high anxiety.


METHODS
The UNWIND trial is a randomized clinical trial of patients with CHD who are at increased risk for adverse events because of comorbid anxiety. One hundred fifty participants with CHD and elevated anxiety symptoms and/or with a diagnosed anxiety disorder will be randomly assigned to 12 weeks of aerobic exercise (3×/wk, 35 min, 70%-85% VO2peak), escitalopram (5-20 mg qd), or placebo. Before and after 12 weeks of treatment, participants will undergo assessments of anxiety symptoms and CHD biomarkers of risk, including measures of inflammation, lipids, hemoglobin A1c, heart rate variability, and vascular endothelial function. Primary outcomes include post-intervention effects on symptoms of anxiety and CHD biomarkers. Secondary outcomes include clinical outcomes (cardiovascular hospitalizations and all-cause death) and measures of quality of life.


CONCLUSIONS
The UNWIND trial (ClinicalTrials.gov NCT02516332) will evaluate the efficacy of aerobic exercise and escitalopram for improving anxiety symptoms and reducing risk for adverse clinical events in anxious CHD patients.
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC. Electronic address: Blume003@mc.duke.edu.
James A
JA
Blumenthal
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
Bryan J
BJ
Feger
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
Patrick J
PJ
Smith
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
Lana L
LL
Watkins
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
Wei
W
Jiang
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
Jonathan
J
Davidson
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
Benson M
BM
Hoffman
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
Megan
M
Ashworth
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
Stephanie K
SK
Mabe
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
Michael A
MA
Babyak
Department of Medicine, Duke University Medical Center, Durham, NC.
William E
WE
Kraus
Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Alan
A
Hinderliter
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC.
Andrew
A
Sherwood
D000328:Adult; D001007:Anxiety / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D015415:Biomarkers / Q000032:analysis; D015283:Citalopram / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000097:blood / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D039721:Diagnostic and Statistical Manual of Mental Disorders; D015444:Exercise / Q000502:physiology / Q000523:psychology; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006339:Heart Rate; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D011580:Psychological Techniques; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage; D016896:Treatment Outcome
D015415:Biomarkers; D015283:Citalopram; D006442:Glycated Hemoglobin; D017367:Selective Serotonin Reuptake Inhibitors