The Resistance Exercise Training for Worry Trial: Replication and Expansion

Not Applicable

Completed

• Conditions: Analogue Generalized Anxiety Disorder

• Registration Number: NCT06804629
• Lead Sponsor: University of Limerick

Brief Summary

This protocol details the full methods of a ten-week moderate-to-high intensity, guidelines-based resistance exercise training intervention compared to a low intensity sham attention control among young adult women with analogue Generalized Anxiety Disorder.

Detailed Description

A recent clinical trial supported the anxiolytic effects of regularly-performed resistance exercise training compared to a waitlist control among young adults with and without at least subclinical, or analogue, Generalized Anxiety Disorder. Although the evidence to date is promising, waitlist control conditions cannot control for potential social and psychological benefits of engaging with most interventions, including social contact, expectations for improvement, and mastery experiences, which could potentially be achieved from easier activities. Therefore, this trial aims to replicate the previously investigated World Health Organization and American College of Sports Medicine guidelines-based resistance exercise training program, and expand on this research by more rigorously examining the effects on anxiety and worry symptoms, independent of potential social and psychological benefits of engagement with the intervention. Consequently, this trial quantifies the acute and chronic effects of moderate-to-high intensity, guidelines-based resistance exercise training compared to a low intensity SHAM attention control on signs and symptoms of Generalized Anxiety Disorder among at-risk young adult women with Analogue Generalized Anxiety Disorder. This trial consists of a two-week familiarization protocol, eight weeks of formal resistance exercise training, and a one-month post-intervention follow-up.

Study Timeline

• Study Start: 2023-10-09
• Status Verified: 2025-01
• Primary Completion: 2025-01-05
• Study Completion: 2025-01-05
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• Female
• Aged 18-40y
• Met criteria for analogue Generalized Anxiety Disorder

Exclusion Criteria

• Medical contraindications to doing resistance exercise training
• Currently involved in formal resistance exercise training
• Currently pregnant or post-partum

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Analogue Generalized Anxiety Disorder Status	Week 12	Penn State Worry Questionnaire of 45 or greater (Meyer et al., 1990)
Worry Symptoms	Week 12	16-item Penn State Worry Questionnaire (Meyer et al., 1990)

Secondary Outcome Measures

Name	Time	Method
Rumination	Week 12	Rumination-Reflection Questionnaire (Trapnell and Campbell, 1999)
Cognitive Functioning	Week 8	Trail Making Test (Tombaugh, 2004)
Irritability Symptoms	Week 12	21-item Irritability Questionnaire (Craig et al., 2008)
Anxiety Symptoms	Post-acute resistance exercise bout week 8	State anxiety was measured using the State (STAI-Y1) subscale of the State-Trait Anxiety Inventory (Spielberger, 2010)
Depressive Symptoms	Week 12	16-item Quick Inventory of Depressive Symptomatology (Rush et al., 2003)
Mood	Post-acute resistance exercise bout week 8	Subscales of the Profile of Mood States - Brief Form (McNair et al., 1992)
Analogue Major Depressive Disorder Status	Week 12	Psychiatric Diagnostic Screening Questionnaire Major Depressive Disorder subscale score of 9 or greater (Zimmerman \& Mattia, 2001)
Analogue Panic Disorder Status	Week 12	Psychiatric Diagnostic Screening Questionnaire Panic Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Analogue Social Anxiety Disorder Status	Week 12	Psychiatric Diagnostic Screening Questionnaire Social Anxiety Disorder subscale score of 4 or greater (Zimmerman \& Mattia, 2001)
Sleep Quality	Week 12	Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Resistance Exercise Expectations	Post-acute resistance exercise bout week 8	15-item Expected Psychological Outcomes of Acute Resistance Exercise (EPO-ARE) derived from the Expected Psychological Outcomes of Exercise Questionnaire (Lindheimer et al., 2020). Participants are asked to "think about how you would expect to feel after one resistance exercise workout relative to how you typically feel".
Physical Activity	Week 12	7-day Physical Activity Recall (Blair et al., 1985)
Muscle-Strengthening Exercise Activity	Week 12	Muscle-Strengthening Exercise Questionnaire - Short Version (Shakespear-Druery et al., 2022)

Trial Locations

Locations (1)

University of Limerick; 🇮🇪 Limerick, Munster, Ireland