Exercise Training for the Treatment of Generalized Anxiety Disorder

NCT00953654 | Completed Results

• 1 other identifier: UGA-2009-01913-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder; Exercise Training; Strength Training; Mental Health

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Strength Training

EXPERIMENTAL

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

Endurance Training

EXPERIMENTAL

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

Waiting List Control

NO INTERVENTION

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.

Interventions

Strength Training OTHER

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.

Strength Training

Endurance Training OTHER

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.

Endurance Training

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead

Study Sites (1)

The University of Georgia

Athens, Georgia, 30602-6554, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Psychological Well-Being

Interventions

Resistance Training; Endurance Training

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

One limitation of this trial was the small sample size. Although the research design was sufficiently powered to detect a statistically significant effect for the primary outcome, a larger trial is warranted.

Results Point of Contact

• Title: Matthew P. Herring, PhD
• Organization: The University of Georgia

mph8@uga.edu

706-542-4381

Study Officials

• Matthew P Herring, MS, MEd

  The University of Georgia

  PRINCIPAL INVESTIGATOR

• Patrick J O'Connor, PhD

  The University of Georgia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 6, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 9, 2016
• Results First Posted: September 29, 2010

Record last verified: 2016-07

Locations

US (1)