Analogue Generalized Anxiety Disorder Clinical Trial
Official title:
Effects of Resistance Exercise Among Young Adults With and Without Analogue Generalized Anxiety Disorder: A Protocol for a Randomized Controlled Trial
| Verified date | October 2019 |
| Source | University of Limerick |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 95 |
| Est. completion date | May 3, 2019 |
| Est. primary completion date | May 3, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility |
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: - |
| Country | Name | City | State |
|---|---|---|---|
| Ireland | The Department of Physical Education and Sport Sciences Building | Limerick |
| Lead Sponsor | Collaborator |
|---|---|
| University of Limerick | Irish Research Council |
Ireland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Analogue-Generalized Anxiety Disorder Status | The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther) | Baseline | |
| Primary | Analogue-Generalized Anxiety Disorder Status | The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther) | week1 | |
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Baseline | |
| Secondary | Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 1 | |
| Secondary | Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 2 | |
| Secondary | Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 3 | |
| Secondary | Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 4 | |
| Secondary | Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 5 | |
| Secondary | Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 6 | |
| Secondary | Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 7 | |
| Secondary | Depressive Symptoms | 16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr) | Week 8 | |
| Secondary | Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Baseline | |
| Secondary | Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 1 | |
| Secondary | Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 2 | |
| Secondary | Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 3 | |
| Secondary | Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 4 | |
| Secondary | Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 5 | |
| Secondary | Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 6 | |
| Secondary | Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 7 | |
| Secondary | Mood | Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992) | Week 8 | |
| Secondary | Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Baseline | |
| Secondary | Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 1 | |
| Secondary | Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 2 | |
| Secondary | Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 3 | |
| Secondary | Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 4 | |
| Secondary | Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 5 | |
| Secondary | Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 6 | |
| Secondary | Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 7 | |
| Secondary | Irritability | 21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res) | Week 8 | |
| Secondary | Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Baseline | |
| Secondary | Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 1 | |
| Secondary | Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 2 | |
| Secondary | Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 3 | |
| Secondary | Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 4 | |
| Secondary | Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 5 | |
| Secondary | Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 6 | |
| Secondary | Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 7 | |
| Secondary | Sleep Quality | Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res) | Week 8 | |
| Secondary | Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Baseline | |
| Secondary | Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 1 | |
| Secondary | Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 2 | |
| Secondary | Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 3 | |
| Secondary | Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 4 | |
| Secondary | Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 5 | |
| Secondary | Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 6 | |
| Secondary | Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 7 | |
| Secondary | Non-Intervention Physical Activity | 7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol) | Week 8 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Attentional Biases | Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol) | Baseline | |
| Secondary | Attentional Biases | Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol) | Week 1 | |
| Secondary | Attentional Biases | Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol) | Week 8 | |
| Secondary | Cognitive Function | Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol) | Baseline | |
| Secondary | Cognitive Function | Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol) | Week1 | |
| Secondary | 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 |