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

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ClinicalTrials.gov Identifier: NCT02915874
Recruitment Status : Completed
First Posted : September 27, 2016
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jess G. Fiedorowicz, University of Iowa

Brief Summary:
The goal of this study is to evaluate the effectiveness of a brief, intensive 1-day psychotherapy group intervention (Acceptance and Commitment Therapy, ACT), compared to a 12 week time control group on anxiety symptoms, vascular function, inflammation, muscle sympathetic nerve activity (mSNA), and oxidant stress. Similar measures will be performed at baseline in individuals with low or no anxiety for comparison. Individuals who are interested in the study will be identified by an online screening survey and will be contacted by the research team; advertisements, flyers and mass emails will direct individuals to the online screening survey. Those deemed eligible to participate will be randomized to the ACT intervention or a control group. Assessments of anxiety symptoms (via various surveys) and vascular function (via non-invasive, well-established techniques) will be performed at baseline and 12 weeks post-ACT group intervention session. In addition, reassessment of anxiety symptoms via aforementioned surveys will take place 6 weeks post-ACT group session. After 12 weeks, anxiety and vascular assessments will be repeated to re-evaluate severity of anxiety symptoms, vascular function, inflammation, and oxidant stress.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Acceptance and Commitment Therapy Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Acceptance and Commitment Therapy Behavioral Intervention

Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:

  1. 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;
  2. 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.
Behavioral: Acceptance and Commitment Therapy
No Intervention: Control
Subjects randomized to not receive treatment.



Primary Outcome Measures :
  1. Beck Anxiety Inventory (BAI) [ Time Frame: Baseline, 6 weeks and 12 weeks ]
    Self-report measure of anxiety. The test consists of 21 questions graded on a scale of 0 (not at all) to 3 (severely). Range of total score is 0 to 63. Higher scores indicate more severe anxiety symptoms.


Secondary Outcome Measures :
  1. State-Trait Anxiety Inventory (STAI) - State Anxiety [ Time Frame: Baseline, 6 weeks and 12 weeks ]
    Self-reported anxiety measures. STAI-Form Y-1 total score. Consists of 20 questions based on a 4-point Likert scale. Range of total score is 20 to 80. Higher scores indicate greater anxiety.

  2. Flow-mediated Dilation of the Brachial Artery [ Time Frame: Baseline and 12 weeks ]
    Flow-mediated dilation of the brachial artery will be assessed by ultrasound following a 5 minute distal occlusion. Larger values are better. Data was collected for the first 5 cohorts.

  3. Pulse Wave Velocity (PWV) [ Time Frame: Baseline and 12 weeks ]
    Carotid-Femoral PWV (cm/sec)

  4. Forearm Blood Flow [ Time Frame: Baseline and 12 weeks ]
    Forearm volume (FAV). Peak Forearm blood flow was assessed by plethysmography (mL/100 mL FAV/min).

  5. Muscle Sympathetic Nerve Activity [ Time Frame: Baseline, 6 weeks and 12 weeks ]
    Muscle sympathetic nerve activity will be measured directly through the peroneal nerve over a 30 minute recording. The processed signal for neural activity will be processed as bursts/minute. Data was collected for the last 3 cohorts.

  6. State-Trait Anxiety Inventory (STAI) - Trait Anxiety [ Time Frame: Baseline, 6 weeks and 12 weeks ]
    Self-reported anxiety measure. STAI-Form Y2 total score. Consists of 20 questions based on a 4-point Likert scale. Range of total score is 20 to 80. Higher scores indicate greater anxiety.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915874


Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: Jess G Fiedorowicz, MD, PhD University of Iowa
  Study Documents (Full-Text)

Documents provided by Jess G. Fiedorowicz, University of Iowa:
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Responsible Party: Jess G. Fiedorowicz, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02915874    
Other Study ID Numbers: 201409782
First Posted: September 27, 2016    Key Record Dates
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders