ExTRA - Exercise Therapy to Reduce Anxiety Pilot Study

Not Applicable

• Conditions: Anxiety; Mental Health - Anxiety

• Registration Number: ACTRN12623000125628
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-07
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Community dwelling adults aged 40-79 years with clinically significant anxiety, defined by a Depression, Anxiety and Stress Scale (DASS-21) anxiety score >7.
Participants need to have capacity to consent, internet/email/ZOOM access and ability to safely undertake an unsupervised exercise intervention.

Exclusion Criteria

Exclusions include a significant medical condition(s) that precludes participation in the exercise intervention, insufficient English literacy to complete outcome measures and having another mental health symptom as the focus of their presentation, e.g. psychosis or mania, acute risk such as suicidality. These criteria are intentionally broad given this is a real world” pragmatic study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptability and usability measured by website usage data including number of log ins and pages clicked on the internet platform, online outcome measure completion, and the evaluation questionnaire which is specifically designed for this study.[Ongoing measurement from baseline until 8 weeks post intervention commencement; evaluation questionnaire at 8 weeks post intervention commencement.];Feasibility measured by screening, recruitment and retention rates. This will be calculated by examining study records, in particular, number of participants who undertake screening for the study, proportion who provide informed consent to participate and proportion of participants who complete the study.[Ongoing measurement from baseline until 8 weeks post intervention commencement; retention rate at 8 weeks post intervention commencement.];Anxiety measured by the Depression, Anxiety and Stress Scale (DASS-21)[Baseline and Week 8 (primary timepoint) post intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Primary outcome: Physical activity (PA) level measured by wearable activity monitor (WAM) steps/day[Baseline, Weeks 1-8 (primary timepoint) post intervention commencement];Primary outcome: Global Physical Activity Questionnaire (GPAQ WHO)[Baseline, Weeks 4 and 8 (primary timepoint) post intervention commencement];Adapted exercise self-efficacy scale (EXSE)[Baseline, Weeks 4 and 8 post intervention commencement];Adapted exercise barrier self-efficacy scale (BARSE)[Baseline, Weeks 1-8 post intervention commencement];Depression measured by the DASS-21[Baseline and Week 8 post intervention commencement];Stress measured by the DASS-21[Baseline and Week 8 post intervention commencement];Dementia risk measured by the ANU-Alzheimer’s Disease Risk Index Short Form (ANU-ADRI-SF)[Baseline, Week 8 post intervention commencement]