Exercise Training for the Treatment of Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
University of Georgia
ClinicalTrials.gov Identifier:
NCT00953654
First received: August 4, 2009
Last updated: August 3, 2011
Last verified: August 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014