Lifestyle Interventions for Generalized Anxiety Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Lifestyle Interventions for Generalized Anxiety Disorder

Conditions
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Aerobic Exercise, Stretching

Intervention / Treatment
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* Behavioral: Aerobic exercise
* Behavioral: Stretching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants, ages 18-65. Principal diagnosis of Generalized Anxiety Disorder. Willing to and capable of providing informed consent, attending all study visits, and complying with the protocol. Classified as either being at low risk or moderate risk for cardiovascular disease according to American College of Sports Medicine (ACSM) risk stratification guidelines (see Telephone Prescreen and Risk Stratification section for more information). Sedentary as defined by ACSM guidelines as not participating in at least 30 minutes of moderate-intensity exercise on at least 3 days a week for at least 3 months. Exclusion Criteria: Currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (I, II, or NOS), schizophrenia or schizoaffective disorder, anorexia, bulimia. Alcohol or drug dependence, abuse of depressants, dissociative anesthetics, hallucinogens, opioids, and cocaine within the last 6 months. Comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the protocol. Cognitive behavioral therapy within three months of baseline, or ongoing supportive therapy directed specifically toward the treatment of anxiety or mood disorder. Psychotropic medications are acceptable only if they are stabilized for at least 3 weeks prior to the baseline visit, as long they are not considered a relative or absolute contraindication to the use of any treatment option in the protocol. For women, currently pregnant, plans to be pregnant in the next year, or currently breastfeeding. Insufficient command of the English language (i.e., they cannot carry on a conversation with an interviewer in the English language or read associated text).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aerobic exercise<br>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. | Behavioral: Aerobic exercise<br> <br> |
| Sham Comparator: stretching<br>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. | Behavioral: Stretching<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |