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| Name | Class |
|---|---|
| Boston University | OTHER |
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This two-site (Southern Methodist University (SMU) and Boston University (BU)) study aims to examine the effectiveness of exercise interventions for the treatment of generalized anxiety disorder (GAD). If effective, the use of exercise as a component of treatment for GAD would have a significant public health impact. In addition to improving GAD treatment outcome, exercise is expected to offer health benefits and promote further lifestyle changes.
The present study involves the randomization of 52 adults with GAD to either a 12-week combined supervised- home-based moderate-intensity aerobic exercise protocol (EX) or a 12-week combined supervised- home-based stretching protocol (CTRL). The investigators hypothesize that participants in the EX intervention will evidence greater improvements in anxiety symptoms and quality of life relative to individuals receiving the control intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic exercise | Active Comparator | The exercise intervention is a 12-week program involving 150 minutes of moderate intensity exercise (65-69% of participant's age-predicted [220-age] maximum heart rate) each week. Participants will complete one 50-minute supervised treadmill exercise session in the laboratory and 100 minutes of exercise on their own. These exercises may include walking, jogging, biking, or other forms of aerobic exercise. The at-home exercise regimen will be individualized for each participant. |
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| stretching | Sham Comparator | The exercise intervention is a 12-week program involving 150 minutes of stretching each week (one 50-minute stretching session in the laboratory and 100 minutes of stretching at home). Participants in the stretching condition will work with a facilitator to create a stretching regimen for 100 minutes of home stretching throughout the week. The facilitator will provide a list of potential stretches with descriptions on how to perform them. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise | Behavioral |
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| Stretching |
| Measure | Description | Time Frame |
|---|---|---|
| Penn State worry Questionnaire | The PSWQ is a 16-item inventory designed to capture the generality, excessiveness, and uncontrollability of pathological worry. It has been shown to have good internal consistency with samples consisting of older adults with GAD | changes from baseline to week 13 |
| GAD-7 | The GAD-7 is a self-reported questionnaire for screening and severity measurement of generalized anxiety disorder (GAD). The researchers conclude that the "GAD-7 is a valid and efficient tool" to screen for anxiety and to assess "its severity in clinical practice and research." | changes from baseline to week 13 |
| Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | This questionnaire rates 16 aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. The Q-LES-Q will be used to examine changes in quality of life with treatment. | changes from baseline to week 13 |
| Clinical Global Impressions Improvement/Severity (CGI) | The CGI-I is a measure of global improvement rated from 1 (very much improved) to 7 (very much worse). The CGI-S measures global severity rated from 1 (not ill) to 7 (extremely ill). | changes from baseline to week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Anxiety Inventory (BAI) | The BAI is a commonly used 21-item, self-report inventory designed to measure severity of anxiety symptoms. | changes from baseline to week 13 |
| Beck Depression Inventory (BDI) |
| Measure | Description | Time Frame |
|---|---|---|
| Health and Risk Assessment Screening. | The American College of Sports Medicine risk stratification health screening (see Appendix) is a self-guided review of health and medical history for known diseases and signs, symptoms, and risk factors for cardiovascular disease. Female participants will also be administered a pregnancy test. | screening week 0 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BU Center for Anxiety and Related Disorders, Boston University | Boston | Massachusetts | 02215 | United States | ||
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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The BDI is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms.
| changes from baseline to week 13 |
| Anxiety Sensitivity | Anxiety sensitivity was measured using the Anxiety Sensitivity Index a 16-item questionnaire designed to assess one's tendency to respond fearfully to anxiety-related symptoms. Data on the reliability and validity of the ASI scales have been favorable . | changes from baseline to week 13 |
| Social Physique Anxiety | The SPAS is a 7-item scale measuring individual anxiety regarding one's figure or physique. | changes from baseline to week 13 |
| Psychiatric Diagnoses | Diagnostic exclusions and lifetime prevalence of Axis I diagnoses will be determined by the Structured Clinical Interview for DSM-IV non-patient version (SCID-NP; First et al., 2004) during Screening Visit 1. The SCID will be administered during by trained doctoral-level interviewers and will be supervised by the PIs, as has been done successfully in the past (e.g., Zvolensky, Leen-Feldner et al., 2004; Smits et al., 2009). | Screening week 0 |
| The Columbia Suicide Severity Rating Scale (C-SSRS) | C-SSRS is a standardized measure of current and past self-injurious behavior, suicidal intent, and suicidal behaviors. The C-SSRS has demonstrated good reliability and validity (Hammad et al., 2006; Posner et al., 2007). The C-SSRS will be administered at the Screening Visit. | Screening week 0 |
| Anxiety Research and Treatment Program, SMU Department of Psychology |
| Dallas |
| Texas |
| 75206 |
| United States |