Lifestyle Interventions for Generalized Anxiety Disorder
|ClinicalTrials.gov Identifier: NCT01644812|
Recruitment Status : Terminated
First Posted : July 19, 2012
Last Update Posted : August 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Aerobic Exercise Stretching||Behavioral: Aerobic exercise Behavioral: Stretching||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lifestyle Interventions for Generalized Anxiety Disorder|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||July 2013|
Active Comparator: Aerobic exercise
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
Sham Comparator: stretching
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.
- Penn State worry Questionnaire [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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).
- Beck Anxiety Inventory (BAI) [ Time Frame: 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) [ Time Frame: changes from baseline to week 13 ]The BDI is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms.
- Anxiety Sensitivity [ Time Frame: 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 .
- Social Physique Anxiety [ Time Frame: changes from baseline to week 13 ]The SPAS is a 7-item scale measuring individual anxiety regarding one's figure or physique.
- Health and Risk Assessment Screening. [ Time Frame: 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.
- Psychiatric Diagnoses [ Time Frame: 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).
- The Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644812
|United States, Massachusetts|
|BU Center for Anxiety and Related Disorders, Boston University|
|Boston, Massachusetts, United States, 02215|
|United States, Texas|
|Anxiety Research and Treatment Program, SMU Department of Psychology|
|Dallas, Texas, United States, 75206|