Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573125
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
A Feasibility and Preliminary Efficacy Study of an App-Based Physical Activity Intervention MoodMover for Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility and Preliminary Efficacy of an App-Based Physical Activity Intervention for Individuals With Depression MoodMover A Protocol for a Single-Arm Pre-Post Intervention Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Exercise is recommended as a standalone treatment for mild-to-moderate depression in Canada However its unclear how mental health practitioners can guide patients to structured in-person exercise programs In cases where such programs are not available or are unattractive to some self-guided mobile health physical activity interventions could be a potential alternative The investigators have been following a behavioural intervention development framework to create a 9-week app-based physical activity intervention called MoodMover for people with depression To evaluate the feasibility and preliminary efficacy of MoodMover this study will employ a single-arm pre-post experimental trial
Detailed Description:
MoodMover is a 9-week app-based physical activity intervention comprising a one-week run-in period followed by eight major lessons each complemented by an optional lesson with new lessons becoming available on a weekly basis Each major lesson addresses a specific topic designed to enhance physical activity engagement covering topics including 1 feeling better through daily activity 2 making physical activity enjoyable 3 building self-confidence 4 building physical activity opportunities 5 developing self-regulatory skills 6 drawing on social support 7 forming an exercise habit and 8 building exercise identity Key features include step tracker exercise logging with mood monitoring action planning gamification and anonymized communications among users
PRIMARY OBJECTIVE This trial primarily aims to evaluate the feasibility and acceptability of MoodMover In addition the study will preliminarily assess the efficacy of MoodMover by monitoring changes in daily step counts the main behavioral outcome of interest Furthermore the study will assess alterations in depressive symptoms and explore the association between these changes
RESEARCH METHODOLOGY All participants will begin by completing baseline assessments on REDCap They will then participate in a 15-minute orientation session via Zoom with a researcher on the programs start date The first five orientation sessions will be recorded and evaluated by an independent researcher using a fidelity checklist allowing for immediate improvements in treatment fidelity Following the orientation participants will use MoodMover as directed for the duration of the 9-week program No additional support will be offered except for technical issues After completing the intervention participants will undergo a follow-up assessment on REDCap Participants will be encouraged to keep the app on their smartphones and continue using it after the program concludes If they choose not to uninstall the app this will be considered implied consent for the researcher to monitor their ongoing user engagement and physical activity data for an additional 9-week follow-up period At the end of this period participants will be contacted to sync their step data with MoodMover enabling the collection of physical activity data throughout the follow-up Additionally participants will be asked to complete a satisfaction survey on REDCap
STATISTICAL ANALYSIS The analysis will involve 1 Descriptive statistics 2 Regression-based analyses to evaluate the relationships between feasibility outcomes and other variables and 3 Random effects mixed modeling to assess the impact of MoodMover on secondary outcomes and the relationship between changes in physical activity and depressive symptoms As an underpowered single-arm feasibility study the reporting of efficacy outcomes will focus on estimation
PRIMARY OBJECTIVE This trial primarily aims to evaluate the feasibility and acceptability of MoodMover In addition the study will preliminarily assess the efficacy of MoodMover by monitoring changes in daily step counts the main behavioral outcome of interest Furthermore the study will assess alterations in depressive symptoms and explore the association between these changes
RESEARCH METHODOLOGY All participants will begin by completing baseline assessments on REDCap They will then participate in a 15-minute orientation session via Zoom with a researcher on the programs start date The first five orientation sessions will be recorded and evaluated by an independent researcher using a fidelity checklist allowing for immediate improvements in treatment fidelity Following the orientation participants will use MoodMover as directed for the duration of the 9-week program No additional support will be offered except for technical issues After completing the intervention participants will undergo a follow-up assessment on REDCap Participants will be encouraged to keep the app on their smartphones and continue using it after the program concludes If they choose not to uninstall the app this will be considered implied consent for the researcher to monitor their ongoing user engagement and physical activity data for an additional 9-week follow-up period At the end of this period participants will be contacted to sync their step data with MoodMover enabling the collection of physical activity data throughout the follow-up Additionally participants will be asked to complete a satisfaction survey on REDCap
STATISTICAL ANALYSIS The analysis will involve 1 Descriptive statistics 2 Regression-based analyses to evaluate the relationships between feasibility outcomes and other variables and 3 Random effects mixed modeling to assess the impact of MoodMover on secondary outcomes and the relationship between changes in physical activity and depressive symptoms As an underpowered single-arm feasibility study the reporting of efficacy outcomes will focus on estimation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None