Does Treating Anxiety Symptoms With ACT Improve Vascular Inflammation and Function? (ACT on Anxiety)
Anxiety
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
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 erythematosis, 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, infliximab (Remicade®), etanercept (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. orlistat (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.
Sites / Locations
- University of Iowa Hospitals and Clinics
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Acceptance and Commitment Therapy Behavioral Intervention
Control
Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered: Behavioral Change training will involve a) teaching subjects how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and those related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations (i.e. learning how to recognize, and develop cognitive distances from unhelpful thoughts such as "I can't take this anymore" and learning how to willingly face experiences that cannot be changed). In-session exercises and practice will be heavily emphasized during the group intervention and handouts will be distributed for home use.
Subjects randomized to not receive treatment.