Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06626425
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Well-being Training for Adolescent Depressive Symptoms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Smartphone-based Meditation Training to Reduce Adolescent Depression
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:
This study is being done to see if the Healthy Minds Program app helps adolescents with elevated depressive symptoms Up to 200 participants will be on study for 20 weeks
Detailed Description:
Participants will be randomized into one of two groups Healthy Minds Program intervention group HMP or a water tracking active control group The groups will use different mobile health apps for eight weeks All participants will complete assessments pre-intervention after weeks 2 4 and 6 of the intervention at week 8 post-intervention and at week 20 follow-up Participants will complete a short daily diary set of questions on their social interactions that day Participants will wear a Biostrap band for continuous collection of heart rate movement and daily sleep indices and geolocation data will be extracted from participant phones using the FollowMee app Participants will receive access to the app they were not assigned to after follow-up
Primary Objective
Assess acceptability and preliminary efficacy of an 8-week mHealth meditation training program on depressive symptoms
Secondary Objectives
Investigate effects of the meditation training program on symptoms of anxiety behavior social isolation psychophysiological processes related to health and disease eg sleep Test changes in behavior and psychophysiology as mechanisms of improved mental health Test whether improved mental health is associated with improved academic outcomes
Primary Objective
Assess acceptability and preliminary efficacy of an 8-week mHealth meditation training program on depressive symptoms
Secondary Objectives
Investigate effects of the meditation training program on symptoms of anxiety behavior social isolation psychophysiological processes related to health and disease eg sleep Test changes in behavior and psychophysiology as mechanisms of improved mental health Test whether improved mental health is associated with improved academic outcomes
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