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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and Commitment Therapy Behavioral Intervention | Active Comparator | Subjects randomized to the ACT Intervention group will attend a 1-day group workshop in which two broad areas will be covered:
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| Control | No Intervention | Subjects randomized to not receive treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks and 12 weeks |
| Flow-mediated Dilation of the Brachial Artery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jess G Fiedorowicz, MD, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34672928 | Derived | 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. | |
| 34619441 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
Acceptance and Commitment Therapy |
| FG001 | Control | Subjects randomized to not receive treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
Acceptance and Commitment Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects dropped out of study | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks and 12 weeks |
|
12 weeks after beginning study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
Acceptance and Commitment Therapy |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jess G Fiedorowicz, MD, PhD | University of Iowa | 319-384-9267 | jess-fiedorowicz@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 13, 2018 | Apr 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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. |
| Baseline and 12 weeks |
| Pulse Wave Velocity (PWV) | Carotid-Femoral PWV (cm/sec) | Baseline and 12 weeks |
| Forearm Blood Flow | Forearm volume (FAV). Peak Forearm blood flow was assessed by plethysmography (mL/100 mL FAV/min). | Baseline and 12 weeks |
| 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. | Baseline, 6 weeks and 12 weeks |
| 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. | Baseline, 6 weeks and 12 weeks |
| 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. |
| Started New Anxiety Medication |
|
| BG001 | Control | Subjects randomized to not receive treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Ratio of weight to height | Mean | Standard Deviation | kg/m^2 |
|
| Education Level | Count of Participants | Participants |
|
| OG001 | Control | Subjects randomized to not receive treatment. |
|
|
|
| Secondary | 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. | Subjects dropped out. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks and 12 weeks |
|
|
|
|
| Secondary | 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. | Data was collected for the first 5 cohorts. | Posted | Mean | Standard Deviation | percentage of flow-mediation dilation | Baseline and 12 weeks |
|
|
|
|
| Secondary | Pulse Wave Velocity (PWV) | Carotid-Femoral PWV (cm/sec) | Subjects dropped out. There are additional measurements which are missing at random. | Posted | Mean | Standard Deviation | cm/sec | Baseline and 12 weeks |
|
|
|
|
| Secondary | Forearm Blood Flow | Forearm volume (FAV). Peak Forearm blood flow was assessed by plethysmography (mL/100 mL FAV/min). | Subjects dropped out of study and some measurements are missing at random. | Posted | Mean | Standard Deviation | mL/100 mL FAV/min | Baseline and 12 weeks |
|
|
|
|
| Secondary | 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. | Last 3 cohorts were measured. Furthermore measurements are missing at random. | Posted | Mean | Standard Deviation | bursts/minute | Baseline, 6 weeks and 12 weeks |
|
|
|
|
| Secondary | 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. | Subjects dropped out of study | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks and 12 weeks |
|
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| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Control | Subjects randomized to not receive treatment. | 0 | 28 | 0 | 28 | 0 | 28 |
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| 6 weeks |
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| 12 weeks |
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| 12 weeks |
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| 12 weeks |
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| 12 weeks |
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| 6 weeks |
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| 12 weeks |
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| 6 weeks |
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| 12 weeks |
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