The Resistance Exercise Training for Worry Trial

Not Applicable

Completed

• Conditions: Analogue Generalized Anxiety Disorder
• Interventions: Other: Wait-list; Behavioral: Resistance exercise training

• Registration Number: NCT04116944
• Lead Sponsor: University of Limerick

Brief 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.

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.

Study Timeline

• Study Start: 2018-01-18
• Primary Completion: 2019-05-03
• Study Completion: 2019-05-03
• Status Verified: 2019-10
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Last Update Submitted: 2019-10-03
• Study First Posted: 2019-10-07
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Analogue-Generalized Anxiety Disorder Wait-List	Wait-list	8-week wait-list control condition among young adults with analogue-Generalized Anxiety Disorder
Non-Analogue-Generalized Anxiety Disorder Resistance Training	Resistance exercise training	Resistance exercise training among young adults without analogue-Generalized Anxiety Disorder
Analogue-Generalized Anxiety Disorder Resistance Training	Resistance exercise training	Resistance exercise training among young adults with analogue-Generalized Anxiety Disorder
Non-Analogue-Generalized Anxiety Disorder Wait-List	Wait-list	8-week wait-list control condition among young adults with analogue-Generalized Anxiety Disorder

Primary Outcome Measures

Name	Time	Method
Analogue-Generalized Anxiety Disorder Status	week 8	The Penn State Worry Questionnaire score of 45 or greater (Meyer et al., 1990, Behav Res and Ther)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Department of Physical Education and Sport Sciences Building; 🇮🇪 Limerick, Ireland