Aerobic Exercise, Stretching
Conditions
Brief summary
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.
Interventions
BEHAVIORALAerobic exercise
BEHAVIORALStretching
Sponsors
Boston University
Southern Methodist University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | changes from baseline to week 13 | 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. |
| GAD-7 | changes from baseline to week 13 | 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. |
| Clinical Global Impressions Improvement/Severity (CGI) | changes from baseline to week 13 | 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). |
| Penn State worry Questionnaire | changes from baseline to week 13 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Sensitivity | changes from baseline to week 13 | 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 . |
| Beck Anxiety Inventory (BAI) | changes from baseline to week 13 | The BAI is a commonly used 21-item, self-report inventory designed to measure severity of anxiety symptoms. |
| Beck Depression Inventory (BDI) | changes from baseline to week 13 | The BDI is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms. |
| Social Physique Anxiety | changes from baseline to week 13 | The SPAS is a 7-item scale measuring individual anxiety regarding one's figure or physique. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health and Risk Assessment Screening. | screening week 0 | 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. |
| The Columbia Suicide Severity Rating Scale (C-SSRS) | Screening week 0 | 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. |
| Psychiatric Diagnoses | Screening week 0 | 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). |
Countries
United States
Outcome results
None listed