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Analogue Generalized Anxiety DisorderNCT04116944

The Resistance Exercise Training for Worry Trial

A study testing Resistance exercise training and Wait-list in people with Analogue Generalized Anxiety Disorder, run by University of Limerick at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Analogue Generalized Anxiety Disorder
What is being tested?
Resistance exercise training and Wait-list
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteIreland
Study dates
18 Jan 2018to 3 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Ireland1 site
  • The Department of Physical Education and Sport Sciences Building

    Limerick

Other trials in Ireland

About this study

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

Read the detailed description

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.

Being tested
Resistance exercise training, Wait-list
Keywords
anxiety
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance exercise trainingBehavioural

    Also called weight-lifting, strength training

    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.

  • Wait-listOther

    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.

Study groups in NCT04116944
Study groupRoleWhat they receive
Analogue-Generalized Anxiety Disorder Resistance TrainingExperimentalResistance exercise training among young adults with analogue-Generalized Anxiety Disorder
Receives: Behavioral: Resistance exercise training
Analogue-Generalized Anxiety Disorder Wait-ListOther8-week wait-list control condition among young adults with analogue-Generalized Anxiety Disorder
Receives: Other: Wait-list
Non-Analogue-Generalized Anxiety Disorder Resistance TrainingExperimentalResistance exercise training among young adults without analogue-Generalized Anxiety Disorder
Receives: Behavioral: Resistance exercise training
Non-Analogue-Generalized Anxiety Disorder Wait-ListOther8-week wait-list control condition among young adults with analogue-Generalized Anxiety Disorder
Receives: Other: Wait-list

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline

  2. 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)

    Measured: week1

  3. 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)

    Measured: week 4

  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)

    Measured: week 8

  5. Analogue-Generalized Anxiety Disorder Status

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

    Measured: Baseline

  6. Analogue-Generalized Anxiety Disorder Status

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

    Measured: week1

  7. Analogue-Generalized Anxiety Disorder Status

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

    Measured: week 4

  8. Analogue-Generalized Anxiety Disorder Status

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

    Measured: week 8

Secondary outcomes (69)
  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)

    Measured: Baseline

  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)

    Measured: week 1

  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)

    Measured: week 2

  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)

    Measured: week 3

  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)

    Measured: week 4

  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)

    Measured: week 5

  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)

    Measured: Week 6

  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)

    Measured: Week 7

  9. 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)

    Measured: Week 8

  10. Depressive Symptoms

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

    Measured: Baseline

  11. Depressive Symptoms

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

    Measured: Week 1

  12. Depressive Symptoms

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

    Measured: Week 2

  13. Depressive Symptoms

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

    Measured: Week 3

  14. Depressive Symptoms

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

    Measured: Week 4

  15. Depressive Symptoms

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

    Measured: Week 5

  16. Depressive Symptoms

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

    Measured: Week 6

  17. Depressive Symptoms

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

    Measured: Week 7

  18. Depressive Symptoms

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

    Measured: Week 8

  19. Mood

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

    Measured: Baseline

  20. Mood

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

    Measured: Week 1

  21. Mood

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

    Measured: Week 2

  22. Mood

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

    Measured: Week 3

  23. Mood

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

    Measured: Week 4

  24. Mood

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

    Measured: Week 5

  25. Mood

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

    Measured: Week 6

  26. Mood

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

    Measured: Week 7

  27. Mood

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

    Measured: Week 8

  28. Irritability

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

    Measured: Baseline

  29. Irritability

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

    Measured: Week 1

  30. Irritability

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

    Measured: Week 2

  31. Irritability

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

    Measured: Week 3

  32. Irritability

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

    Measured: Week 4

  33. Irritability

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

    Measured: Week 5

  34. Irritability

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

    Measured: Week 6

  35. Irritability

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

    Measured: Week 7

  36. Irritability

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

    Measured: Week 8

  37. Sleep Quality

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

    Measured: Baseline

  38. Sleep Quality

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

    Measured: Week 1

  39. Sleep Quality

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

    Measured: Week 2

  40. Sleep Quality

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

    Measured: Week 3

  41. Sleep Quality

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

    Measured: Week 4

  42. Sleep Quality

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

    Measured: Week 5

  43. Sleep Quality

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

    Measured: Week 6

  44. Sleep Quality

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

    Measured: Week 7

  45. Sleep Quality

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

    Measured: Week 8

  46. Non-Intervention Physical Activity

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

    Measured: Baseline

  47. Non-Intervention Physical Activity

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

    Measured: Week 1

  48. Non-Intervention Physical Activity

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

    Measured: Week 2

  49. Non-Intervention Physical Activity

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

    Measured: Week 3

  50. Non-Intervention Physical Activity

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

    Measured: Week 4

  51. Non-Intervention Physical Activity

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

    Measured: Week 5

  52. Non-Intervention Physical Activity

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

    Measured: Week 6

  53. Non-Intervention Physical Activity

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

    Measured: Week 7

  54. Non-Intervention Physical Activity

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

    Measured: Week 8

  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)

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

    Measured: Baseline

  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)

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

    Measured: Week 1

  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)

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

    Measured: Week 2

  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)

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

    Measured: Week 3

  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)

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

    Measured: Week 4

  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)

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

    Measured: Week 5

  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)

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

    Measured: Week 6

  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)

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

    Measured: Week 7

  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)

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

    Measured: Week 8

  64. Attentional Biases

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

    Measured: Baseline

  65. Attentional Biases

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

    Measured: Week 1

  66. Attentional Biases

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

    Measured: Week 8

  67. Cognitive Function

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

    Measured: Baseline

  68. Cognitive Function

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

    Measured: Week1

  69. Cognitive Function

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

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2019
  2. Study start18 Jan 2018
  3. Primary completion3 May 2019
  4. Study completion3 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04116944
Sponsor's protocol ID
2017_03_18_EHS
Status last verified
Oct 2019
First submitted
3 Oct 2019
Last updated
7 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcomes measures will be made available.

Publications

  • O'Sullivan D, Gordon BR, Lyons M, Meyer JD, Herring MP. Effects of Resistance Exercise on Depressed Mood State: A Randomized Controlled Trial. Med Sci Sports Exerc. 2025 Nov 1;57(11):2496-2502. doi: 10.1249/MSS.0000000000003769. Epub 2025 May 29.

    PubMed 40440519
  • Gordon BR, McDowell CP, Lyons M, Herring MP. The effects of acute resistance exercise among young adults: A randomized controlled trial. J Affect Disord. 2022 Feb 15;299:102-107. doi: 10.1016/j.jad.2021.11.049. Epub 2021 Nov 18.

    PubMed 34801607
  • Gordon BR, McDowell CP, Lyons M, Herring MP. Resistance exercise training for anxiety and worry symptoms among young adults: a randomized controlled trial. Sci Rep. 2020 Oct 16;10(1):17548. doi: 10.1038/s41598-020-74608-6.

    PubMed 33067493

Questions about this trial

What is this clinical trial studying?

A study testing Resistance exercise training and Wait-list in people with Analogue Generalized Anxiety Disorder, run by University of Limerick at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analogue-Generalized Anxiety Disorder Status (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04116944, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.

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