This protocol details the full methods of a ten-week moderate-to-high intensity, guidelines-based resistance exercise training intervention compared to a low intensity sham attention control among young adult women with analogue Generalized Anxiety Disorder.
A recent clinical trial supported the anxiolytic effects of regularly-performed resistance exercise training compared to a waitlist control among young adults with and without at least subclinical, or analogue, Generalized Anxiety Disorder. Although the evidence to date is promising, waitlist control conditions cannot control for potential social and psychological benefits of engaging with most interventions, including social contact, expectations for improvement, and mastery experiences, which could potentially be achieved from easier activities. Therefore, this trial aims to replicate the previously investigated World Health Organization and American College of Sports Medicine guidelines-based resistance exercise training program, and expand on this research by more rigorously examining the effects on anxiety and worry symptoms, independent of potential social and psychological benefits of engagement with the intervention. Consequently, this trial quantifies the acute and chronic effects of moderate-to-high intensity, guidelines-based resistance exercise training compared to a low intensity SHAM attention control on signs and symptoms of Generalized Anxiety Disorder among at-risk young adult women with Analogue Generalized Anxiety Disorder. This trial consists of a two-week familiarization protocol, eight weeks of formal resistance exercise training, and a one-month post-intervention follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
68
Resistance exercise training was designed in accordance with World Health Organization and American College of Sports Medicine guidelines. The eight-week, twice-weekly intervention was designed such that moderate-to-high intensity participants could achieve two sets of 8-12 repetitions of the eight exercises before volitional fatigue, a deterioration in lifting form, or failure to complete a repetition, using loads of approximately 70-80% of their estimated one-repetition maximum. Completed in the following order, the exercises were: barbell back squat, barbell bench press, hexagon bar deadlift, barbell bent over row, dumbbell lunges, seated dumbbell lateral raises, weighted or unweighted abdominal crunches, and seated dumbbell bicep curls. There was one minute of rest between each set, and two minutes of rest between each exercise. If participants could complete two sets of 12 repetitions, load was increased gradually by approximately 5% in the following session.
The low intensity SHAM condition was matched all features of engagement with the moderate-to-high intensity intervention apart from load, and load progression. Low intensity SHAM participants completed the same program with loads of approximately 20% of their estimated one-repetition maximum. To maintain low intensity, repetitions completed on the main, heavier lifts (i.e., back squat, bench press, deadlift, bent over row) were increased from 10 in one session to 12 in the next; load was then increased by approximately 10% in the following session, and 10 reps were performed again. On the remaining lighter, assistance lifts, eight repetitions were performed per set, then one repetition was added to both sets in each session, and load was increased by the smallest increment possible when two sets of 12 repetitions were performed. Borg's 6-20 rating of perceived exertion scores were used to monitor intensity, such that if scores exceeded 11, load and reps were not progressed.
University of Limerick
Limerick, Munster, Ireland
Analogue Generalized Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Time frame: Baseline
Analogue Generalized Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 1
Analogue Generalized Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 4
Analogue Generalized Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 8
Analogue Generalized Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 12
Analogue Generalized Anxiety Disorder Status
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Time frame: Baseline
Analogue Generalized Anxiety Disorder Status
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Time frame: Week 1
Analogue Generalized Anxiety Disorder Status
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Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Time frame: Week 4
Analogue Generalized Anxiety Disorder Status
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Time frame: Week 8
Analogue Generalized Anxiety Disorder Status
Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Time frame: Week 12
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Baseline
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Pre-week 1
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 1
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 2
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 3
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 4
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 5
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 6
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 7
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 8
Worry Symptoms
16-item Penn State Worry Questionnaire (Meyer et al., 1990)
Time frame: Week 12
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Baseline
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Pre-week 1
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 1
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 2
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 3
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 4
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 5
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 6
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 7
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 8
Anxiety Symptoms
Trait anxiety was measured using the Trait (STAI-Y2) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Week 12
Anxiety Symptoms
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Baseline
Anxiety Symptoms
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Pre-acute resistance exercise bout week 1
Anxiety Symptoms
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Post-acute resistance exercise bout week 1
Anxiety Symptoms
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Pre-acute resistance exercise bout week 8
Anxiety Symptoms
State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Time frame: Post-acute resistance exercise bout week 8
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Baseline
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Pre-week 1
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 1
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 2
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 3
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 4
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 5
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 6
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 7
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 8
Depressive Symptoms
16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Time frame: Week 12
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: Pre-week 1
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
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Week 12
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Pre-acute resistance exercise bout week 1
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Post-acute resistance exercise bout week 1
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Pre-acute resistance exercise bout week 8
Mood
Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Time frame: Post-acute resistance exercise bout week 8
Analogue Major Depressive Disorder Status
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman \& Mattia, 2001)
Time frame: Baseline
Analogue Major Depressive Disorder Status
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 1
Analogue Major Depressive Disorder Status
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 4
Analogue Major Depressive Disorder Status
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 8
Analogue Major Depressive Disorder Status
Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 12
Analogue Panic Disorder Status
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Time frame: Baseline
Analogue Panic Disorder Status
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 1
Analogue Panic Disorder Status
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 4
Analogue Panic Disorder Status
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 8
Analogue Panic Disorder Status
Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 12
Analogue Social Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Time frame: Baseline
Analogue Social Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 1
Analogue Social Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 4
Analogue Social Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 8
Analogue Social Anxiety Disorder Status
Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Time frame: Week 12
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time frame: Baseline
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time frame: Week 1
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time frame: Week 4
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time frame: Week 8
Sleep Quality
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time frame: Week 12
Irritability Symptoms
21-item Irritability Questionnaire (Craig et al., 2008)
Time frame: Baseline
Irritability Symptoms
21-item Irritability Questionnaire (Craig et al., 2008)
Time frame: Week 1
Irritability Symptoms
21-item Irritability Questionnaire (Craig et al., 2008)
Time frame: Week 4
Irritability Symptoms
21-item Irritability Questionnaire (Craig et al., 2008)
Time frame: Week 8
Irritability Symptoms
21-item Irritability Questionnaire (Craig et al., 2008)
Time frame: Week 12
Rumination
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Time frame: Baseline
Rumination
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Time frame: Week 1
Rumination
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Time frame: Week 4
Rumination
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Time frame: Week 8
Rumination
Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Time frame: Week 12
Cognitive Functioning
Stroop Colour and Word Test (Williams et al., 1996)
Time frame: Baseline
Cognitive Functioning
Stroop Colour and Word Test (Williams et al., 1996)
Time frame: Pre-acute resistance exercise bout week 1
Cognitive Functioning
Stroop Colour and Word Test (Williams et al., 1996)
Time frame: Post-acute resistance exercise bout week 1
Cognitive Functioning
Stroop Colour and Word Test (Williams et al., 1996)
Time frame: Pre-acute resistance exercise bout week 8
Cognitive Functioning
Stroop Colour and Word Test (Williams et al., 1996)
Time frame: Post-acute resistance exercise bout week 8
Cognitive Functioning
Stroop Colour and Word Test (Williams et al., 1996)
Time frame: Week 8
Cognitive Functioning
Trail Making Test (Tombaugh, 2004)
Time frame: Baseline
Cognitive Functioning
Trail Making Test (Tombaugh, 2004)
Time frame: Pre-acute resistance exercise bout week 1
Cognitive Functioning
Trail Making Test (Tombaugh, 2004)
Time frame: Post-acute resistance exercise bout week 1
Cognitive Functioning
Trail Making Test (Tombaugh, 2004)
Time frame: Pre-acute resistance exercise bout week 8
Cognitive Functioning
Trail Making Test (Tombaugh, 2004)
Time frame: Post-acute resistance exercise bout week 8
Cognitive Functioning
Trail Making Test (Tombaugh, 2004)
Time frame: Week 8
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Resistance Exercise Training (EPO-RET) questionnaire, derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants were asked "For each of the below outcomes, think about how you would expect to feel after completing a resistance exercise program (2 sessions per week for 8-12 weeks) relative to how you typically feel".
Time frame: Baseline
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Resistance Exercise Training (EPO-RET) questionnaire, derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants were asked "For each of the below outcomes, think about how you would expect to feel after completing a resistance exercise program (2 sessions per week for 8-12 weeks) relative to how you typically feel".
Time frame: Week 1
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Resistance Exercise Training (EPO-RET) questionnaire, derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants were asked "For each of the below outcomes, think about how you would expect to feel after completing a resistance exercise program (2 sessions per week for 8-12 weeks) relative to how you typically feel".
Time frame: Week 4
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Resistance Exercise Training (EPO-RET) questionnaire, derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants were asked "For each of the below outcomes, think about how you would expect to feel after completing a resistance exercise program (2 sessions per week for 8-12 weeks) relative to how you typically feel".
Time frame: Week 8
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Resistance Exercise Training (EPO-RET) questionnaire, derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants were asked "For each of the below outcomes, think about how you would expect to feel after completing a resistance exercise program (2 sessions per week for 8-12 weeks) relative to how you typically feel".
Time frame: Week 12
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Time frame: Pre-acute resistance exercise bout week 1
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Time frame: Post-acute resistance exercise bout week 1
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Time frame: Pre-acute resistance exercise bout week 8
Resistance Exercise Expectations
15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Time frame: Post-acute resistance exercise bout week 8
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Baseline
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Pre-week 1
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 1
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 2
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 3
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 4
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 5
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 6
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 7
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 8
Physical Activity
7-day Physical Activity Recall (Blair et al., 1985)
Time frame: Week 12
Muscle-Strengthening Exercise Activity
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Time frame: Baseline
Muscle-Strengthening Exercise Activity
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Time frame: Week 1
Muscle-Strengthening Exercise Activity
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Time frame: Week 4
Muscle-Strengthening Exercise Activity
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Time frame: Week 8
Muscle-Strengthening Exercise Activity
Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)
Time frame: Week 12