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

August 4, 2009
August 3, 2011
August 2009
May 2010   (final data collection date for primary outcome measure)
  • 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.
Clinician diagnosis of Generalized Anxiety Disorder as measured by Anxiety Disorders Interview Schedule-Adult Version severity ratings [ Time Frame: Pre- and post- 6 week training intervention ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00953654 on ClinicalTrials.gov Archive Site
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Exercise Training for the Treatment of Generalized Anxiety Disorder
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.

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).

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Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • 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.
  • 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.
  • 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
    Intervention: Other: Strength Training
  • 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.
    Intervention: Other: Endurance Training
  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00953654
UGA-2009-01913-1
Not Provided
Matthew P. Herring, The University of Georgia
University of Georgia
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Principal Investigator: Matthew P Herring, MS, MEd The University of Georgia
Study Director: Patrick J O'Connor, PhD The University of Georgia
University of Georgia
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP