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
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.
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 →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.
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Exclusion Criteria:
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
Subjects randomized to not receive treatment.
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
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
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
Pulse Wave Velocity (PWV)
Carotid-Femoral PWV (cm/sec)
Time frame: Baseline and 12 weeks
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
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
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
| Milestone | Acceptance and Commitment Therapy Behavioral Intervention | Control |
|---|---|---|
| Started | 44 | 28 |
| Week 6 follow up | 41 | 26 |
| Completed | 38 | 22 |
| Not completed | 6 | 6 |
| Withdrew: Lost to follow-up | 5 | 4 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Started new anxiety medication | 0 | 1 |
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.
| score on a scale | Acceptance and Commitment Therapy Behavioral Intervention | Control |
|---|---|---|
| Baseline | 18.750 ± 8.334 | 17.464 ± 7.951 |
| 6 weeks | 13.317 ± 8.413 | 16.154 ± 8.624 |
| 12 weeks | 11.053 ± 8.077 | 14.727 ± 10.315 |
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.
| score on a scale | Acceptance and Commitment Therapy Behavioral Intervention | Control |
|---|---|---|
| Baseline | 43.227 ± 9.246 | 44.143 ± 6.980 |
| 6 weeks | 43.000 ± 12.538 | 48.885 ± 9.688 |
| 12 weeks | 39.658 ± 11.516 | 42.682 ± 10.895 |
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.
| percentage of flow-mediation dilation | Acceptance and Commitment Therapy Behavioral Intervention | Control |
|---|---|---|
| Baseline | 3.448 ± 4.884 | 5.913 ± 4.151 |
| 12 weeks | 4.269 ± 3.243 | 4.574 ± 2.231 |
Carotid-Femoral PWV (cm/sec)
| cm/sec | Acceptance and Commitment Therapy Behavioral Intervention | Control |
|---|---|---|
| Baseline | 630.335 ± 254.534 | 640.811 ± 144.177 |
| 12 weeks | 620.608 ± 183.534 | 639.938 ± 158.349 |
Forearm volume (FAV). Peak Forearm blood flow was assessed by plethysmography (mL/100 mL FAV/min).
| mL/100 mL FAV/min | Acceptance and Commitment Therapy Behavioral Intervention | Control |
|---|---|---|
| Baseline | 23.546 ± 8.434 | 19.307 ± 4.943 |
| 12 weeks | 25.181 ± 8.431 | 19.969 ± 7.444 |
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.
| bursts/minute | Acceptance and Commitment Therapy Behavioral Intervention | Control |
|---|---|---|
| Baseline | 13.890 ± 10.427 | 21.550 ± 11.476 |
| 6 weeks | 13.343 ± 8.652 | 23.967 ± 13.876 |
| 12 weeks | 19.104 ± 11.283 | 29.877 ± 11.835 |
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.
| score on a scale | Acceptance and Commitment Therapy Behavioral Intervention | Control |
|---|---|---|
| Baseline | 53.205 ± 7.893 | 56.179 ± 8.748 |
| 6 weeks | 46.902 ± 11.975 | 53.846 ± 9.456 |
| 12 weeks | 44.842 ± 11.305 | 51.136 ± 9.662 |
Collected over 12 weeks after beginning study. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acceptance and Commitment Therapy Behavioral Intervention | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Control | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Age, Continuous(years) | Acceptance and Commitment Therapy Behavioral Intervention | Control | Total |
|---|---|---|---|
| Mean | 33 ± 8.7 | 37.1 ± 10.1 | 34.6 ± 9.4 |
| Sex: Female, Male(Participants) | Acceptance and Commitment Therapy Behavioral Intervention | Control | Total |
|---|---|---|---|
| Female | 29 | 20 | 49 |
| Male | 15 | 8 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Acceptance and Commitment Therapy Behavioral Intervention | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 2 | 8 |
| Not Hispanic or Latino | 38 | 26 | 64 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Acceptance and Commitment Therapy Behavioral Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 4 | 1 | 5 |
| White | 36 | 25 | 61 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Body Mass Index(kg/m^2) | Acceptance and Commitment Therapy Behavioral Intervention | Control | Total |
|---|---|---|---|
| Mean | 26.1 ± 4.8 | 29.6 ± 6.3 | 27.4 ± 5.6 |
| Education Level(Participants) | Acceptance and Commitment Therapy Behavioral Intervention | Control | Total |
|---|---|---|---|
| Some College | 2 | 6 | 8 |
| College Degree | 22 | 14 | 36 |
| Graduate or Professional Degree | 20 | 8 | 28 |
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University of Iowa