Lifestyle Interventions for Generalized Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Penn State worry Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants, ages 18-
- •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.
排除标准
- •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).
结局指标
主要结局
Penn State worry Questionnaire
时间窗: 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
GAD-7
时间窗: 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."
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
时间窗: 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.
Clinical Global Impressions Improvement/Severity (CGI)
时间窗: 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).
次要结局
- Beck Anxiety Inventory (BAI)(changes from baseline to week 13)
- Beck Depression Inventory (BDI)(changes from baseline to week 13)
- Anxiety Sensitivity(changes from baseline to week 13)
- Social Physique Anxiety(changes from baseline to week 13)
研究者
Jasper Smits, Ph.D.
Associate Professor
Southern Methodist University