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Completed

NCT Number: NCT04116944

The Resistance Exercise Training for Worry Trial

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.

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Key information

Conditions

Analogue Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Department of Physical Education and Sport Sciences Building

Limerick, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Resistance Exercise Training

Behavioral

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.

Other names: weight-lifting, strength training

Wait-list

Other

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.

Primary outcomes

  1. Analogue-Generalized Anxiety Disorder Status

    Time frame: Baseline

    The Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001, Arch of Gen Psychiatr)

  2. Analogue-Generalized Anxiety Disorder Status

    Time frame: week1

    The Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001, Arch of Gen Psychiatr)

  3. Analogue-Generalized Anxiety Disorder Status

    Time frame: week 4

    The Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001, Arch of Gen Psychiatr)

  4. Analogue-Generalized Anxiety Disorder Status

    Time frame: week 8

    The Psychiatric Diagnostic Screening Questionnaire Generalized Anxiety Disorder subscale score of 6 or greater (Zimmerman & Mattia, 2001, Arch of Gen Psychiatr)

  5. Analogue-Generalized Anxiety Disorder Status

    Time frame: Baseline

    The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)

  6. Analogue-Generalized Anxiety Disorder Status

    Time frame: week1

    The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)

  7. Analogue-Generalized Anxiety Disorder Status

    Time frame: week 4

    The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)

  8. Analogue-Generalized Anxiety Disorder Status

    Time frame: week 8

    The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)

Secondary outcomes

  1. Anxiety Symptoms

    Time frame: Baseline

    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)

  2. Anxiety Symptoms

    Time frame: week 1

    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)

  3. Anxiety Symptoms

    Time frame: week 2

    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)

  4. Anxiety Symptoms

    Time frame: week 3

    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)

  5. Anxiety Symptoms

    Time frame: week 4

    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)

  6. Anxiety Symptoms

    Time frame: week 5

    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)

  7. Anxiety Symptoms

    Time frame: Week 6

    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)

  8. Anxiety Symptoms

    Time frame: Week 7

    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)

  9. Anxiety Symptoms

    Time frame: Week 8

    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)

  10. Depressive Symptoms

    Time frame: Baseline

    16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)

  11. Depressive Symptoms

    Time frame: Week 1

    16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)

  12. Depressive Symptoms

    Time frame: Week 2

    16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)

  13. Depressive Symptoms

    Time frame: Week 3

    16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)

  14. Depressive Symptoms

    Time frame: Week 4

    16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)

  15. Depressive Symptoms

    Time frame: Week 5

    16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)

  16. Depressive Symptoms

    Time frame: Week 6

    16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)

  17. Depressive Symptoms

    Time frame: Week 7

    16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)

  18. Depressive Symptoms

    Time frame: Week 8

    16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003, Bio Psychiatr)

  19. Mood

    Time frame: Baseline

    Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)

  20. Mood

    Time frame: Week 1

    Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)

  21. Mood

    Time frame: Week 2

    Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)

  22. Mood

    Time frame: Week 3

    Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)

  23. Mood

    Time frame: Week 4

    Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)

  24. Mood

    Time frame: Week 5

    Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)

  25. Mood

    Time frame: Week 6

    Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)

  26. Mood

    Time frame: Week 7

    Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)

  27. Mood

    Time frame: Week 8

    Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)

  28. Irritability

    Time frame: Baseline

    21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)

  29. Irritability

    Time frame: Week 1

    21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)

  30. Irritability

    Time frame: Week 2

    21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)

  31. Irritability

    Time frame: Week 3

    21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)

  32. Irritability

    Time frame: Week 4

    21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)

  33. Irritability

    Time frame: Week 5

    21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)

  34. Irritability

    Time frame: Week 6

    21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)

  35. Irritability

    Time frame: Week 7

    21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)

  36. Irritability

    Time frame: Week 8

    21-item Irritability Questionnaire (Craig et al., 2008, Psychiatr Res)

  37. Sleep Quality

    Time frame: Baseline

    Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)

  38. Sleep Quality

    Time frame: Week 1

    Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)

  39. Sleep Quality

    Time frame: Week 2

    Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)

  40. Sleep Quality

    Time frame: Week 3

    Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)

  41. Sleep Quality

    Time frame: Week 4

    Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)

  42. Sleep Quality

    Time frame: Week 5

    Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)

  43. Sleep Quality

    Time frame: Week 6

    Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)

  44. Sleep Quality

    Time frame: Week 7

    Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)

  45. Sleep Quality

    Time frame: Week 8

    Pittsburgh Sleep Quality Index (Buysse et al., 1989, Psychiatr Res)

  46. Non-Intervention Physical Activity

    Time frame: Baseline

    7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)

  47. Non-Intervention Physical Activity

    Time frame: Week 1

    7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)

  48. Non-Intervention Physical Activity

    Time frame: Week 2

    7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)

  49. Non-Intervention Physical Activity

    Time frame: Week 3

    7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)

  50. Non-Intervention Physical Activity

    Time frame: Week 4

    7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)

  51. Non-Intervention Physical Activity

    Time frame: Week 5

    7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)

  52. Non-Intervention Physical Activity

    Time frame: Week 6

    7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)

  53. Non-Intervention Physical Activity

    Time frame: Week 7

    7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)

  54. Non-Intervention Physical Activity

    Time frame: Week 8

    7-day Physical Activity Recall (Blair et al., 1985, Am J of Epidemiol)

  55. 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)

    Time frame: Baseline

    Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health

  56. 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)

    Time frame: Week 1

    Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health

  57. 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)

    Time frame: Week 2

    Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health

  58. 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)

    Time frame: Week 3

    Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health

  59. 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)

    Time frame: Week 4

    Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health

  60. 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)

    Time frame: Week 5

    Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health

  61. 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)

    Time frame: Week 6

    Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health

  62. 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)

    Time frame: Week 7

    Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health

  63. 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)

    Time frame: Week 8

    Participants are asked to what degree they believe a single bout of exercise will improve or worsen various domains of physical and mental health

  64. Attentional Biases

    Time frame: Baseline

    Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol)

  65. Attentional Biases

    Time frame: Week 1

    Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol)

  66. Attentional Biases

    Time frame: Week 8

    Attentional bias to positive, negative, and neutral facial images (Gotlin et al., 2004, J of Abnorm Psychol)

  67. Cognitive Function

    Time frame: Baseline

    Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol)

  68. Cognitive Function

    Time frame: Week1

    Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol)

  69. Cognitive Function

    Time frame: Week 8

    Stroop colour and word test, (Williams et al., 1996, Psychol Bull) and Trail Making Test (Tombaugh, 2004, Arch of Clin Neuropsychol)

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Collaborators

  • Irish Research Council

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 7, 2019
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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