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
|Condition or disease||Intervention/treatment||Phase|
|Anxiety||Behavioral: Acceptance and Commitment Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
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:
Behavioral: Acceptance and Commitment Therapy
No Intervention: Control
Subjects randomized to not receive treatment.
- 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.
- 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.
- 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.
- Pulse Wave Velocity (PWV) [ Time Frame: Baseline and 12 weeks ]Carotid-Femoral PWV (cm/sec)
- 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).
- 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.
- 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.
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
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Jess G Fiedorowicz, MD, PhD||University of Iowa|