The Resistance Exercise Training for Worry Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Resistance Exercise Among Young Adults With and Without Analogue Generalized Anxiety Disorder: A Protocol for a Randomized Controlled Trial

Conditions
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Analogue Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Resistance exercise training
* Other: Wait-list


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria were age 18-40y; no medical contraindication to safe participation in resistance exercise training; and no current pregnancy or lactation. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Analogue-Generalized Anxiety Disorder Resistance Training<br>Resistance exercise training among young adults with analogue-Generalized Anxiety Disorder | Behavioral: Resistance exercise training<br>* 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.<br>* Other names: strength training;|
| Other: Analogue-Generalized Anxiety Disorder Wait-List<br>8-week wait-list control condition among young adults with analogue-Generalized Anxiety Disorder | Other: Wait-list<br>* 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.<br>|
| Experimental: Non-Analogue-Generalized Anxiety Disorder Resistance Training<br>Resistance exercise training among young adults without analogue-Generalized Anxiety Disorder | Behavioral: Resistance exercise training<br>* 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.<br>* Other names: strength training;|
| Other: Non-Analogue-Generalized Anxiety Disorder Wait-List<br>8-week wait-list control condition among young adults with analogue-Generalized Anxiety Disorder | Other: Wait-list<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | Baseline | 
| Analogue-Generalized Anxiety Disorder Status | The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther) | week1 | 
| Analogue-Generalized Anxiety Disorder Status | The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther) | week 4 | 
| Analogue-Generalized Anxiety Disorder Status | The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther) | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Week 8 | 
| Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Baseline | 
| Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 1 | 
| Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 2 | 
| Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 3 | 
| Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 4 | 
| Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 5 | 
| Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 6 | 
| Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 7 | 
| Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 8 | 
| Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Baseline | 
| Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 1 | 
| Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 2 | 
| Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 3 | 
| Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 4 | 
| Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 5 | 
| Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 6 | 
| Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 7 | 
| Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 8 | 
| Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Baseline | 
| Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 1 | 
| Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 2 | 
| Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 3 | 
| Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 4 | 
| Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 5 | 
| Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 6 | 
| Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 7 | 
| Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 8 | 
| Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Baseline | 
| Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 1 | 
| Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 2 | 
| Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 3 | 
| Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 4 | 
| Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 5 | 
| Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 6 | 
| Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 7 | 
| Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 8 | 
| Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Baseline | 
| Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 1 | 
| Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 2 | 
| Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 3 | 
| Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 4 | 
| Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 5 | 
| Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 6 | 
| Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 7 | 
| Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Week 8 | 
| Attentional Biases | Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol) | Baseline | 
| Attentional Biases | Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol) | Week 1 | 
| Attentional Biases | Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol) | 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) | Baseline | 
| Cognitive Function | Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol) | Week1 | 
| Cognitive Function | Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol) | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety