Ignite Creation Date:
2024-05-06 @ 4:02 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04846777
Status:
RECRUITING
Last Update Posted:
2022-04-26
First Post:
2021-04-09
Brief Title:
Brief Smartphone Treatment Study
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Brief Smartphone Treatment Study for Anxiety and Depression
Status:
RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Little is known about whether and how brief mindfulness therapies yield clinically beneficial effects This gap exists despite the rapid growth of smartphone mindfulness applications and presence of mental health treatment gap Specifically no prior brief smartphone mindfulness ecological momentary intervention MEMI has targeted generalized anxiety disorder GAD Moreover although theories propose that mindfulness intervention can boost attentional control AC executive functioning EF perspective-taking and social cognition skills they have largely gone untested Thus this randomized controlled trial RCT aims to address these gaps by assessing the efficacy of a 14-day smartphone mindfulness EMI vs placebo Participants with GAD will be randomly assigned to either MEMI or self-monitoring placebo SMP Those in treatment will exercise multiple core mindfulness strategies open monitoring acceptance attending to small moments slowed rhythmic diaphragmatic breathing Also those in MEMI will be reminded before bedtime that mindfulness is a lifelong practice Comparatively participants assigned to SMP will only be prompted to practice self-monitoring They will notice their thoughts rate any distress associated with them and will not be taught any mindfulness strategies All prompts will occur 5 times a day for 14 consecutive days They will complete self-reports and neuropsychological assessments at pre- post- and 1-month follow-up Multilevel modeling analyses will determine if treatment vs self-monitoring placebo SMP produces substantially larger reductions in trait worry and negative perseverative cognitions as well as steeper increases in AC and EF inhibition set-shifting working memory updating In addition the investigators hypothesized that MEMI vs SMP would lead to greater increases in performance-based and self-reported trait mindfulness empathy and perspective taking Findings will advance understanding of the efficacy of unguided technology-assisted brief mindfulness in a clinical sample
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None