Lifestyle Interventions for Generalized Anxiety Disorder

Stopped early · Not applicable

Conditions studied: Aerobic Exercise, Stretching

In brief

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.

Key facts

Study ID

NCT01644812

Run by

Southern Methodist University

People needed

10

Starts

2012-03-01

Last updated by the study team

2013-08-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• BU Center for Anxiety and Related Disorders, Boston University — Boston, Massachusetts, United States
• Anxiety Research and Treatment Program, SMU Department of Psychology — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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