Does Treating Anxiety Symptoms With ACT Improve Vascular Inflammation and Function?

The investigators hypothesize that reducing the burden of anxiety symptoms using Acceptance
and Commitment Therapy (ACT) will improve vascular function, inflammation, mSNA, and oxidant
stress.

The investigation also explore other secondary endpoints related to oxidant stress and
inflammation in vascular endothelial cells. If anxiety increases inflammation, then we
predict that ACT will reduce circulating pro-inflammatory cytokines, and produce a phenotype
of endothelial cell proteins reflecting decreased inflammation compared to pre-treatment. And
if anxiety increases oxidative stress, then ACT should produce a phenotype of endothelial
cell proteins reflecting decreased oxidant stress and increased nitric oxide synthase
activity.

Inclusion Criteria:

- Willing and able to provide written, signed consent after the nature of the study has
been explained, and prior to any research-related procedures.

- Age is > or = 25 and < or = 65 years of age.

- Healthy, as determined by health history questionnaire, blood chemistries, and 12-lead
ECG.

- Blood chemistries indicative of normal renal (creatinine <2.0mg/dl), liver (<3 times
upper limit for ALT, AST), and thyroid function (TSH between 0.4 - 5.0 mU/L) or on
stable thyroid medication with no dose change for 3 months.

- If currently receiving treatment with or taking any of the following supplements, must
be willing and able to discontinue taking for 2 weeks prior to each study visit and/or
throughout the treatment period: Vitamin C, E or other multivitamins containing
vitamin C or E; omega-3 fatty acids; Phosphodiesterase (PDE) 5 inhibitors (i.e.
Viagra®, Cialis®, Levitra®, or Revatio®); PDE 3 inhibitors (e.g., cilostazol
(Pletal®), milrinone, or vesnarinone).

- No history of cardiovascular disease (e.g., heart attack, stroke, heart failure,
valvular heart disease, cardiomyopathy), or peripheral arterial disease.

- Non-smokers, defined as no history of smoking or no smoking for at least the past 3
months.

- Normal resting 12-lead ECG (no evidence of myocardial infarction, left ventricular
hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
fibrillation/flutter. atherosclerosis).

Exclusion Criteria:

- Current diagnosis or history of cancer, liver disease, HIV/AIDS

- History of brain tumor, aneurysm or injury

- Clinical diagnosis of mental health disorders such as bipolar disorder or
schizophrenia

- History of cardiovascular disease such as heart angioplasty/stent or bypass surgery,
myocardial infarction, stroke, heart failure with or without LV ejection fraction
<40%, cardiomyopathy, valvular heart disease, cardiomyopathy, heart transplantation,
atherosclerosis.

- Current tobacco user or history of tobacco use within the past 3 months (cigarettes,
cigars, chewing tobacco, Hookah).

- History of lung emphysema, chronic bronchitis or chronic obstructive pulmonary disease
(COPD).

- Abnormal resting 12-lead ECG (e.g., evidence of myocardial infarction, left
ventricular hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
fibrillation/flutter, atherosclerosis).

- Serious neurologic disorders including seizures.

- History of renal failure, dialysis or kidney transplant.

- Use of any investigational products or investigational medical devices within 30 days
prior to screening, or requirement for any investigational agent prior to completion
of all scheduled study assessments.

- Recent flu-like symptoms within the past 2 weeks.

- Pregnant or breastfeeding at screening, or planning to become pregnant (self or
partner) at any time during the study. A urinary pregnancy test will be done on all
females. If test is positive, the subject will be excluded.

- History of rheumatoid arthritis, Grave's disease, systemic lupus erythamatosis, and
Wegener's granulomatosis.

- Taking anticoagulation, anti-seizure, or antipsychotic agents.

- Start of or dose change to an antidepressant or anti-anxiety medication within the
past 3 months (if no change in medication or dose in past 3 month, then subject will
be eligible).

- Intention to start or current psychotherapy for anxiety and/or depression while
enrolled in study.

- Immunodeficiency or systemic autoimmune disease.

- History of bleeding disorders or conditions of the microcirculation (i.e. von
Willebrand disease, Raynaud's disease).

- History of co-morbid condition that would limit life expectancy to <1 year.

- Taking chronic non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin,
indomethacin, naproxen, acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®) and not
able or willing to go off of for 2 weeks prior to each study visit.

- Taking cox-2 inhibitors (Celebrex®, Vioxx®, etc) or allopurinol (Zyloprim®, Lopurin®,
Aloprim®).

- Taking steroids or biologics: corticosteroids (prednisone); methotrexate, infliximib
(Remicade®), etaneracept (Enbrel®); anakinra (Kineret®).

- Vulnerable populations (prisoners, etc.) will not be eligible to participate in this
study.

- Current alcohol abuse.

- On weight loss drugs (i.e. orilistat (Xenical®), sibutramine (Meridia®),
phenylpropanol-amine (Acutrim®)), or similar over-the-counter medications within 3
months of screening.

- Any condition that, in the view of the PI or Co-I, places the subject at high risk or
poor treatment and study compliance.