CClinicalTrials.gg
CompletedNCT02915874ACT on AnxietyUpdated Jul 5, 2019Results posted

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

An interventional study of Acceptance and Commitment Therapy in Anxiety, sponsored by University of Iowa. Completed at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by University of Iowa · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anxiety

Browse trials for

03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 72 is close to the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • 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.

Interventions

  • BehavioralAcceptance and Commitment Therapy
06

What researchers measure

Primary outcomes

  1. Beck Anxiety Inventory (BAI)

    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.

    Time frame: Baseline, 6 weeks and 12 weeks

Secondary outcomes

  1. State-Trait Anxiety Inventory (STAI) - State Anxiety

    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.

    Time frame: Baseline, 6 weeks and 12 weeks

  2. Flow-mediated Dilation of the Brachial Artery

    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.

    Time frame: Baseline and 12 weeks

  3. Pulse Wave Velocity (PWV)

    Carotid-Femoral PWV (cm/sec)

    Time frame: Baseline and 12 weeks

  4. Forearm Blood Flow

    Forearm volume (FAV). Peak Forearm blood flow was assessed by plethysmography (mL/100 mL FAV/min).

    Time frame: Baseline and 12 weeks

  5. Muscle Sympathetic Nerve Activity

    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.

    Time frame: Baseline, 6 weeks and 12 weeks

  6. State-Trait Anxiety Inventory (STAI) - Trait Anxiety

    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.

    Time frame: Baseline, 6 weeks and 12 weeks

07

Results

Posted Jul 5, 2019
Limitations and caveats
Participants were mostly Caucasian and were not blinded to the treatment. No attempt was made to measure participants understanding and use of the ACT processes or changes in psychological flexibility.

Participant flow

Participant flow — Overall Study
MilestoneAcceptance and Commitment Therapy Behavioral InterventionControl
Started4428
Week 6 follow up4126
Completed3822
Not completed66
Withdrew: Lost to follow-up54
Withdrew: Withdrawal by subject11
Withdrew: Started new anxiety medication01

Outcome measures

PrimaryBeck Anxiety Inventory (BAI)

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.

Time frame:
Baseline, 6 weeks and 12 weeks
Reported as:
Mean · score on a scale
Beck Anxiety Inventory (BAI)
score on a scaleAcceptance and Commitment Therapy Behavioral InterventionControl
Baseline18.750 ± 8.33417.464 ± 7.951
6 weeks13.317 ± 8.41316.154 ± 8.624
12 weeks11.053 ± 8.07714.727 ± 10.315
Statistical analysis
  • Acceptance and Commitment Therapy Behavioral Intervention vs Control · Mixed Models Analysis · p = 0.02 (a priori threshold: 0.05) · Slope: -1.13
SecondaryState-Trait Anxiety Inventory (STAI) - State Anxiety

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.

Time frame:
Baseline, 6 weeks and 12 weeks
Reported as:
Mean · score on a scale
State-Trait Anxiety Inventory (STAI) - State Anxiety
score on a scaleAcceptance and Commitment Therapy Behavioral InterventionControl
Baseline43.227 ± 9.24644.143 ± 6.980
6 weeks43.000 ± 12.53848.885 ± 9.688
12 weeks39.658 ± 11.51642.682 ± 10.895
Statistical analysis
  • Acceptance and Commitment Therapy Behavioral Intervention vs Control · Mixed Models Analysis · p = 0.19 (a priori threshold: 0.05) · Slope: -1.02
SecondaryFlow-mediated Dilation of the Brachial Artery

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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · percentage of flow-mediation dilation
Flow-mediated Dilation of the Brachial Artery
percentage of flow-mediation dilationAcceptance and Commitment Therapy Behavioral InterventionControl
Baseline3.448 ± 4.8845.913 ± 4.151
12 weeks4.269 ± 3.2434.574 ± 2.231
Statistical analysis
  • Acceptance and Commitment Therapy Behavioral Intervention vs Control · Mixed Models Analysis · p = 0.27 (a priori threshold: 0.05) · Slope: 2.07
SecondaryPulse Wave Velocity (PWV)

Carotid-Femoral PWV (cm/sec)

Time frame:
Baseline and 12 weeks
Reported as:
Mean · cm/sec
Pulse Wave Velocity (PWV)
cm/secAcceptance and Commitment Therapy Behavioral InterventionControl
Baseline630.335 ± 254.534640.811 ± 144.177
12 weeks620.608 ± 183.534639.938 ± 158.349
Statistical analysis
  • Acceptance and Commitment Therapy Behavioral Intervention vs Control · Mixed Models Analysis · p = 0.98 (a priori threshold: 0.05) · Slope: -0.49
SecondaryForearm Blood Flow

Forearm volume (FAV). Peak Forearm blood flow was assessed by plethysmography (mL/100 mL FAV/min).

Time frame:
Baseline and 12 weeks
Reported as:
Mean · mL/100 mL FAV/min
Forearm Blood Flow
mL/100 mL FAV/minAcceptance and Commitment Therapy Behavioral InterventionControl
Baseline23.546 ± 8.43419.307 ± 4.943
12 weeks25.181 ± 8.43119.969 ± 7.444
Statistical analysis
  • Acceptance and Commitment Therapy Behavioral Intervention vs Control · Mixed Models Analysis · p = 0.69 (a priori: 0.05) · Slope: 1.03
SecondaryMuscle Sympathetic Nerve Activity

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.

Time frame:
Baseline, 6 weeks and 12 weeks
Reported as:
Mean · bursts/minute
Muscle Sympathetic Nerve Activity
bursts/minuteAcceptance and Commitment Therapy Behavioral InterventionControl
Baseline13.890 ± 10.42721.550 ± 11.476
6 weeks13.343 ± 8.65223.967 ± 13.876
12 weeks19.104 ± 11.28329.877 ± 11.835
Statistical analysis
  • Acceptance and Commitment Therapy Behavioral Intervention vs Control · Mixed Models Analysis · p = 0.58 · Slope: -2.77
SecondaryState-Trait Anxiety Inventory (STAI) - Trait Anxiety

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.

Time frame:
Baseline, 6 weeks and 12 weeks
Reported as:
Mean · score on a scale
State-Trait Anxiety Inventory (STAI) - Trait Anxiety
score on a scaleAcceptance and Commitment Therapy Behavioral InterventionControl
Baseline53.205 ± 7.89356.179 ± 8.748
6 weeks46.902 ± 11.97553.846 ± 9.456
12 weeks44.842 ± 11.30551.136 ± 9.662
Statistical analysis
  • Acceptance and Commitment Therapy Behavioral Intervention vs Control · Mixed Models Analysis · p = 0.08 (a priori threshold: 0.05) · Slope: -1.02

Adverse events

Collected over 12 weeks after beginning study. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Acceptance and Commitment Therapy Behavioral Intervention0/44 (0%)0/44 (0%)0/44 (0%)
Control0/28 (0%)0/28 (0%)0/28 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Acceptance and Commitment Therapy Behavioral InterventionControlTotal
Mean33 ± 8.737.1 ± 10.134.6 ± 9.4
Sex: Female, Male
Sex: Female, Male(Participants)Acceptance and Commitment Therapy Behavioral InterventionControlTotal
Female292049
Male15823
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Acceptance and Commitment Therapy Behavioral InterventionControlTotal
Hispanic or Latino628
Not Hispanic or Latino382664
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Acceptance and Commitment Therapy Behavioral InterventionControlTotal
American Indian or Alaska Native000
Asian404
Native Hawaiian or Other Pacific Islander011
Black or African American415
White362561
More than one race000
Unknown or Not Reported011
Body Mass Index
Body Mass Index(kg/m^2)Acceptance and Commitment Therapy Behavioral InterventionControlTotal
Mean26.1 ± 4.829.6 ± 6.327.4 ± 5.6
Education Level
Education Level(Participants)Acceptance and Commitment Therapy Behavioral InterventionControlTotal
Some College268
College Degree221436
Graduate or Professional Degree20828
08

Study locations

1 site
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
09

References and documents

Publications

  • Dindo L, Fiedorowicz JG, Boykin DM, Wooldridge N, Myers J, Ajibewa T, Stroud A, Kuwaye D, Liu Z, Pierce GL. A randomized controlled trial for symptoms of anxiety and depression: Effects of a 1-day acceptance and commitment training workshop. Ann Clin Psychiatry. 2021 Nov;33(4):258-269. doi: 10.12788/acp.0046. PubMed 34672928 ↗
  • Fiedorowicz JG, Dindo L, Ajibewa T, Persons J, Marchman J, Holwerda SW, Abosi OJ, DuBose LE, Wooldridge N, Myers J, Stroud AK, Dubishar K, Liu Z, Pierce GL. One-day acceptance and commitment therapy (ACT) workshop improves anxiety but not vascular function or inflammation in adults with moderate to high anxiety levels in a randomized controlled trial. Gen Hosp Psychiatry. 2021 Nov-Dec;73:64-70. doi: 10.1016/j.genhosppsych.2021.09.009. Epub 2021 Sep 28. PubMed 34619441 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 13, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02915874
Lead sponsor
University of Iowa
Responsible party
Jess G. Fiedorowicz (Associate Professor, University of Iowa) — Principal investigator
First posted
Sep 27, 2016
Start date
Oct 2014
Primary completion
Dec 2017
Completion
Dec 2017
Results posted
Jul 5, 2019
Last update
Jul 5, 2019

Study contacts

Jess G Fiedorowicz, MD, PhD
principal investigator · University of Iowa

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion