Exercise Training for the Treatment of Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

Exercise Training for the Treatment of Generalized Anxiety Disorder: A Randomized Controlled Trial Comparing Endurance and Strength Training Among Sedentary Women With Generalized Anxiety Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953654
• Other study ID #: UGA-2009-01913-1
• Status: Completed
• Phase: N/A
• First received: August 4, 2009
• Last updated: August 3, 2011
• Start date: August 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2010
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of 6 weeks of endurance or strength training and a wait list comparison condition on symptoms of Generalized Anxiety Disorder (GAD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Women aged 18-39 years

• Principal diagnosis of Generalized Anxiety Disorder according to DSM-IV diagnostic criteria (comorbidities will be acceptable as long as Generalized Anxiety Disorder is the principal diagnosis)

Exclusion Criteria:

• A score of less than 45 on the Penn State Worry Questionnaire

• A score of less than 7 on the Generalized Anxiety Disorder section of the Psychiatric Diagnostic Screening Questionnaire

• Expending greater than 250 kilocalories per kilogram body weight per week as measured by a 7-day physical activity recall questionnaire

• Engaging in greater than 6 exercise bouts in the month prior to recruitment

• Pregnancy

• Any medical contraindications (cardiovascular or musculoskeletal) to exercise training according to American College of Sports Medicine guidelines

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder

Intervention

Other:
• Strength Training
6 weeks of strength training exercise sessions involving leg press, leg curl, and leg extension exercises twice weekly at an intensity progressing from 50% to 75% of predicted one-repetition maximum across the 6 weeks of the trial.
• Endurance Training
Six weeks of lower-body dynamic cycling exercise completed on an electronically-braked cycle ergometer twice weekly. The intervention will be matched to the strength training intervention on total work completed, total time actively engaged in exercise, a focus on leg muscles, and load (intensity) progression across the 6 week training protocol.

Locations

Country	Name	City	State
United States	The University of Georgia	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings	GAD is characterized by persistent excessive or pathologic worry most days for at least 6 months about activities of daily life that is difficult to control and associated with at least 3 of the following symptoms: restlessness, feeling on edge, being easily fatigued, difficulty concentrating, irritability, muscle tension, and sleep difficulty. Symptoms are not caused by a substance or disorder, but cause significant distress or functional impairment. Remission was measured using the ADIS-IV from 1-16 days following the 6-week intervention.	Pre- and post- 6 week training intervention	No
Primary	Worry Symptoms	Worry symptoms, hallmark symptoms of GAD, were assessed using the Penn State Worry Questionnaire (PSWQ). The PSWQ is a 16-item self-report questionnaire that measures pathological worry symptoms. Participants rate items from 1 "not at all typical of me" to 5 "very typical of me." Scores range from 16 to 80, with higher scores indicated exacerbated worry symptoms. Symptoms were assessed at baseline and at the beginning of the second weekly session during weeks 2, 4, and 6.	Baseline, Week 2, Week 4, Week 6	No