Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647121
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
A Randomized Pilot Trial Investigating a Novel Mobile Application for Practicing Exercises from ACT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Pilot and Feasibility Trial Investigating a Mobile Application-Delivered Mindfulness Exercise for Navigating Psychological Distress Dropping Anchor Delivered As a Stepwise Image Sequence
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Mindfulness-related skills are associated with positive mental health outcomes and can be effectively taught through mobile apps However further research is needed to determine how best to support skill acquisition through the delivery of mindfulness exercises via smartphone apps ACTaide is a novel mobile app designed to support home practice of mindfulness-related skills through exercises presented as stepwise annotated image sequences The primary objective of this pilot and feasibility trial is to evaluate the feasibility of a prototype version of ACTaide This two-arm parallel single-blinded blinded participants pilot trial will be conducted virtually with distressed Canadian adults Participants N 60 will be recruited through the online platform Prolific The intervention group will receive an Acceptance and Commitment Therapy ACT psychoeducational workshop and access to ACTaide for two weeks to support home practice of a mindfulness exercise from ACT dropping anchor The control group will receive the same psychoeducational workshop and access to a reminders-only mobile app to support their practice of the dropping anchor exercise The main outcome measures will assess intervention feasibility including adherence to the intervention acceptability of the app and retention rates In addition measures related to mindfulness-related skills and psychological distress will be collected Prespecified progression criteria will be used to determine whether and how to proceed to a future trial designed to investigate the efficacy of ACTaide
Detailed Description:
None
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