This protocol details the full methods of two parallel, randomized controlled trials of an eight-week resistance exercise training intervention compared to a wait-list control condition among young adults with and without analogue-Generalized Anxiety Disorder.
Recent meta-analyses support the chronic anxiolytic effects of resistance exercise training among women with diagnosed Generalized Anxiety Disorder. However, the effects of resistance exercise training among those with subclinical, or analogue-Generalized Anxiety Disorder is unknown. This protocol details the full methods of two parallel, randomized controlled trials of an eight-week resistance exercise training intervention compared to a wait-list control condition among young adults with and without analogue-Generalized Anxiety Disorder. Analogue-Generalized Anxiety Disorder status was determined using validated cut-scores for both the Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder sub-scale score of 6 or greater, and the Penn State Worry Questionnaire score of 45 or greater. The ecologically-valid resistance exercise training was designed according to World Health Organization and American College of Sports Medicine guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
95
The ecologically-valid resistance exercise training was designed according to World Health Organization and American College of Sports Medicine guidelines. The eight-week, twice-weekly intervention was designed to be performed at a moderate intensity. The resistance of each exercise was such that when participants could successfully complete 2 sets of 12 repetitions at a certain load, the resistance was increased incrementally up to 5% for the following session. Exercise sessions were scheduled with at least one day of rest between sessions. The eight exercises included the barbell squat, barbell bench press, hexagon bar deadlift, dumbbell shoulder lateral raise, barbell bent over rows, dumbbell lunges, dumbbell curls, and abdominal crunches.
Participants randomized to the delayed-start wait-list condition completed questionnaires once-weekly. The investigator sent a weekly email to the participant providing links to the questionnaires. Participants that completed the eight-week wait-list condition were offered the eight weeks of RET either immediately upon completion, or later at a time of their convenience while the trial was ongoing. Each participant randomized to the eight-week wait-list also completed two 30-minute bouts of seated quiet rest in an empty room at weeks one and eight.
The Department of Physical Education and Sport Sciences Building
Limerick, Ireland
Analogue-Generalized Anxiety Disorder Status
The Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001, Arch of Gen Psychiatr)
Time frame: Baseline
Analogue-Generalized Anxiety Disorder Status
The Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001, Arch of Gen Psychiatr)
Time frame: week1
Analogue-Generalized Anxiety Disorder Status
The Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001, Arch of Gen Psychiatr)
Time frame: week 4
Analogue-Generalized Anxiety Disorder Status
The Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001, Arch of Gen Psychiatr)
Time frame: week 8
Analogue-Generalized Anxiety Disorder Status
The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)
Time frame: Baseline
Analogue-Generalized Anxiety Disorder Status
The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)
Time frame: week1
Analogue-Generalized Anxiety Disorder Status
The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)
Time frame: week 4
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Analogue-Generalized Anxiety Disorder Status
The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)
Time frame: week 8
Anxiety Symptoms
State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)
Time frame: Baseline
Anxiety Symptoms
State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)
Time frame: week 1
Anxiety Symptoms
State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)
Time frame: week 2
Anxiety Symptoms
State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)
Time frame: week 3
Anxiety Symptoms
State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)
Time frame: week 4
Anxiety Symptoms
State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)
Time frame: week 5
Anxiety Symptoms
State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)
Time frame: Week 6
Anxiety Symptoms
State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)
Time frame: Week 7
Anxiety Symptoms
State and trait anxiety were measured using the State (STAI-Y1) and Trait (STAI-Y2) subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol)
Time frame: Week 8
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)
Time frame: Baseline
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)
Time frame: Week 1
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)
Time frame: Week 2
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)
Time frame: Week 3
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)
Time frame: Week 4
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)
Time frame: Week 5
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)
Time frame: Week 6
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)
Time frame: Week 7
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)
Time frame: Week 8
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Baseline
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 1
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 2
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 3
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 4
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 5
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 6
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 7
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 8
Irritability
21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)
Time frame: Baseline
Irritability
21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)
Time frame: Week 1
Irritability
21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)
Time frame: Week 2
Irritability
21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)
Time frame: Week 3
Irritability
21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)
Time frame: Week 4
Irritability
21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)
Time frame: Week 5
Irritability
21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)
Time frame: Week 6
Irritability
21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)
Time frame: Week 7
Irritability
21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)
Time frame: Week 8
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)
Time frame: Baseline
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)
Time frame: Week 1
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)
Time frame: Week 2
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)
Time frame: Week 3
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)
Time frame: Week 4
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)
Time frame: Week 5
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)
Time frame: Week 6
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)
Time frame: Week 7
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)
Time frame: Week 8
Non-Intervention Physical Activity
7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)
Time frame: Baseline
Non-Intervention Physical Activity
7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)
Time frame: Week 1
Non-Intervention Physical Activity
7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)
Time frame: Week 2
Non-Intervention Physical Activity
7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)
Time frame: Week 3
Non-Intervention Physical Activity
7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)
Time frame: Week 4
Non-Intervention Physical Activity
7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)
Time frame: Week 5
Non-Intervention Physical Activity
7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)
Time frame: Week 6
Non-Intervention Physical Activity
7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)
Time frame: Week 7
Non-Intervention Physical Activity
7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)
Time frame: Week 8
A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health
Time frame: Baseline
A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health
Time frame: Week 1
A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health
Time frame: Week 2
A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health
Time frame: Week 3
A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health
Time frame: Week 4
A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health
Time frame: Week 5
A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health
Time frame: Week 6
A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health
Time frame: Week 7
A novel questionnaire assessing expectancy of exercise to improve or not to improve physical and mental health outcomes. (Lindheimer et al., 2019, Eur J of Sport Sci)
Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health
Time frame: Week 8
Attentional Biases
Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol)
Time frame: Baseline
Attentional Biases
Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol)
Time frame: Week 1
Attentional Biases
Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol)
Time frame: Week 8
Cognitive Function
Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol)
Time frame: Baseline
Cognitive Function
Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol)
Time frame: Week1
Cognitive Function
Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol)
Time frame: Week 8