Exercise Training for the Treatment of Generalized Anxiety Disorder

July 29, 2016 updated by: University of Georgia

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Worry Symptoms
Time Frame: Baseline, Week 2, Week 4, Week 6
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

August 4, 2009

First Submitted That Met QC Criteria

August 4, 2009

First Posted (ESTIMATE)

August 6, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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