Generalized Anxiety Disorder
Conditions
Keywords
Generalized Anxiety Disorder, Exercise Training, Strength Training, Mental Health
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).
Interventions
OTHERStrength 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.
OTHEREndurance 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.
Sponsors
University of Georgia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings | 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. |
| Worry Symptoms | 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. |
Countries
United States
Participant flow
Recruitment details
Women were recruited from from a University and Community setting from August 2009 to March 2010. 1044 women were screened using online screening questionnaires; 853 were excluded for having too few worry symptoms or too high a physical activity level. 55 completed diagnostic interviews - 25 were excluded for no Generalized Anxiety Disorder.
Pre-assignment details
Thirty women met exclusion criteria and were enrolled in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Resistance Exercise Training Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum | 10 |
| Aerobic Exercise Training Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression. | 10 |
| 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. | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Resistance Exercise Training | Aerobic Exercise Training | Waiting List Control | Total |
|---|---|---|---|---|
| Age, Continuous | 25.6 years STANDARD_DEVIATION 7.1 | 20.7 years STANDARD_DEVIATION 3 | 24.2 years STANDARD_DEVIATION 6.3 | 23.5 years STANDARD_DEVIATION 5.9 |
| Age, Customized ≥18 and ≤23 years | 6 participants | 8 participants | 6 participants | 20 participants |
| Age, Customized >23 and ≤29 years | 1 participants | 2 participants | 1 participants | 4 participants |
| Age, Customized >29 and ≤37 years | 3 participants | 0 participants | 3 participants | 6 participants |
| Height | 162.6 centimeters STANDARD_DEVIATION 6.2 | 165.0 centimeters STANDARD_DEVIATION 7.6 | 166.5 centimeters STANDARD_DEVIATION 4.6 | 164.7 centimeters STANDARD_DEVIATION 6.6 |
| Medication Antibiotic | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Medication Antihistamine | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Medication Contraceptive | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Medication Muscle Relaxant | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Medication Norepinephrine-Dopamine Reuptake Inhibitor (NDRI) | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Medication Psychostimulant | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Medication Selective Serotonin Reuptake Inhibitor (SSRI) | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Medication Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Psychiatric Comorbidity Dysthymia | 2 cases | 0 cases | 2 cases | 4 cases |
| Psychiatric Comorbidity Major Depressive Disorder (MDD) | 1 cases | 3 cases | 3 cases | 7 cases |
| Psychiatric Comorbidity Obsessive Compulsive Disorder (OCD) | 1 cases | 1 cases | 3 cases | 5 cases |
| Psychiatric Comorbidity Post-Traumatic Stress Disorder (PTSD) | 0 cases | 0 cases | 2 cases | 2 cases |
| Psychiatric Comorbidity Social Phobia | 2 cases | 5 cases | 5 cases | 12 cases |
| Psychiatric Comorbidity Specific Phobia | 2 cases | 5 cases | 10 cases | 17 cases |
| Psychiatric Comorbidity Substance Abuse | 1 cases | 0 cases | 0 cases | 1 cases |
| Region of Enrollment United States | 10 participants | 10 participants | 10 participants | 30 participants |
| Sex/Gender, Customized Female | 10 participants | 10 participants | 10 participants | 30 participants |
| Weight | 60.6 Kilograms STANDARD_DEVIATION 9.1 | 70.0 Kilograms STANDARD_DEVIATION 15.5 | 66.4 Kilograms STANDARD_DEVIATION 8.1 | 65.7 Kilograms STANDARD_DEVIATION 12.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
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.
Time frame: Pre- and post- 6 week training intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resistance Exercise Training | Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings | 4 Participants |
| Aerobic Exercise Training | Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings | 6 Participants |
| Waiting List Control | Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings | 7 Participants |
Primary
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.
Time frame: Baseline, Week 2, Week 4, Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Resistance Exercise Training | Worry Symptoms | Week 4 | 60.3 Units on a scale (PSWQ) | Standard Deviation 8.29 |
| Resistance Exercise Training | Worry Symptoms | Baseline | 63.80 Units on a scale (PSWQ) | Standard Deviation 9.78 |
| Resistance Exercise Training | Worry Symptoms | Week 6 | 61.1 Units on a scale (PSWQ) | Standard Deviation 10.01 |
| Resistance Exercise Training | Worry Symptoms | Week 2 | 59.83 Units on a scale (PSWQ) | Standard Deviation 9.93 |
| Aerobic Exercise Training | Worry Symptoms | Week 4 | 58.8 Units on a scale (PSWQ) | Standard Deviation 5.2 |
| Aerobic Exercise Training | Worry Symptoms | Week 2 | 63.20 Units on a scale (PSWQ) | Standard Deviation 4.16 |
| Aerobic Exercise Training | Worry Symptoms | Baseline | 62.1 Units on a scale (PSWQ) | Standard Deviation 6.4 |
| Aerobic Exercise Training | Worry Symptoms | Week 6 | 59.3 Units on a scale (PSWQ) | Standard Deviation 7.38 |
| Waiting List Control | Worry Symptoms | Week 2 | 63.4 Units on a scale (PSWQ) | Standard Deviation 8.91 |
| Waiting List Control | Worry Symptoms | Baseline | 64.3 Units on a scale (PSWQ) | Standard Deviation 7.01 |
| Waiting List Control | Worry Symptoms | Week 6 | 65.5 Units on a scale (PSWQ) | Standard Deviation 7.62 |
| Waiting List Control | Worry Symptoms | Week 4 | 63.5 Units on a scale (PSWQ) | Standard Deviation 7.04 |
Comparison: Effects of RET and AET were compared to WL using a 3 condition by 3 time ANCOVA. An a priori statistical power analysis showed that a sample of 30 patients would provide a statistical power of .80 to detect a condition-by-time interaction for PSWQ scores assuming a two-tailed alpha value of 0.05, a correlation across repeated measures of 0.75 and a desire to detect a standardized effect size of 0.65.p-value: <0.05ANCOVA