Exercise Training for the Treatment of Generalized Anxiety Disorder - Full Text View

Sponsor:	University of Georgia
Information provided by:	University of Georgia
ClinicalTrials.gov Identifier:	NCT00953654

Purpose

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).

Condition	Intervention
Generalized Anxiety Disorder	Other: Strength Training Other: Endurance Training

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by University of Georgia:

Primary Outcome Measures:

Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings [ Time Frame: Pre- and post- 6 week training intervention ] [ Designated as safety issue: No ]
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.
Worry Symptoms [ Time Frame: Baseline, Week 2, Week 4, Week 6 ] [ Designated as safety issue: No ]
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.

Enrollment:	30
Study Start Date:	August 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Strength Training Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum	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.
Experimental: Endurance Training Six-week lower-body dynamic cycling exercise condition completed twice weekly and matched to the strength training arm on total work completed, total time actively engaged in exercise and load progression.	Other: 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.
No Intervention: Waiting List Control Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.

Eligibility

Ages Eligible for Study:	18 Years to 39 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953654

Locations

United States, Georgia
The University of Georgia
Athens, Georgia, United States, 30602-6554

Sponsors and Collaborators

University of Georgia

Investigators

Principal Investigator:	Matthew P Herring, MS, MEd	The University of Georgia
Study Director:	Patrick J O'Connor, PhD	The University of Georgia

More Information

No publications provided

Responsible Party:	Matthew P. Herring, The University of Georgia
ClinicalTrials.gov Identifier:	NCT00953654 History of Changes
Other Study ID Numbers:	UGA-2009-01913-1
Study First Received:	August 4, 2009
Results First Received:	August 17, 2010
Last Updated:	August 3, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Georgia:

Generalized Anxiety Disorder
Exercise Training
Strength Training
Mental Health

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012