Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526052
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
A Randomized Controlled Trial Testing the Effect of the Youth Mindful Awareness Program on Negative Affect YMAP2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Targeting Negative Affect Through Mindfulness Training in Youth at Risk for Internalizing Problems R33
Status:
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:
YMAP2
Brief Summary:
The goal of this randomized clinical trial is to compare the effects of an online mindfulness program to an active supportive comparison condition and a no-intervention control group on reducing and preventing mood and anxiety symptoms in at-risk youth Youth who are high on trait negative affect will be randomized to one of the three conditions The primary outcomes of interest are reductions in momentary negative affect and internalizing problems in adolescents ages 12 to 17 years old All participants will be evaluated prior to being randomized after the 9-session intervention period and at a 6-month follow-up
The first hypothesis is that the mindfulness intervention will predict decreases in stressor-reactive momentary negative affect and internalizing symptoms The second hypothesis is that changes in momentary negative affect will partially account for the effects of the mindfulness intervention on internalizing symptoms
The first hypothesis is that the mindfulness intervention will predict decreases in stressor-reactive momentary negative affect and internalizing symptoms The second hypothesis is that changes in momentary negative affect will partially account for the effects of the mindfulness intervention on internalizing symptoms
Detailed Description:
Rates of anxiety and depression in youth are substantial causing a major unmet need for effective prevention and treatment A salient risk factor for anxiety and depression is negative affectivity - a partially heritable propensity to experience and express more frequent intense and enduring aversive emotional states Prior longitudinal studies have shown that elevated trait negative affectivity tNA during mid-adolescence predicted internalizing disorders later in adolescence and early adulthood and this relation was partially mediated by changes in momentary negative affect mNA measured with ecological momentary assessment EMA The conceptual rationale for this investigation is as follows Trait negative affectivity tNA is a risk factor for internalizing symptoms and disorders tNA also predicts higher levels of momentary negative affect mNA measured with EMA which in turn partially accounts for the prospective association between tNA and symptoms of anxiety and depression Mindfulness interventions reduce both mNA and internalizing symptoms Given these empirical relations this study will test whether in youth with high levels of tNA an online coached mindfulness program reduces mNA as measured with EMA and whether significantly reducing mNA via a mindfulness intervention then prevents the worsening or onset of internalizing problems
Mindfulness-based interventions have been found to reduce negative affect and internalizing symptoms in children and adolescents This study will evaluate changes in mNA as a transdiagnostic target of mindfulness-based training in youth at high risk ie high tNA for internalizing problems and the degree to which reductions in such mNA partially account for the effects of mindfulness training on internalizing outcomes in youth This randomized controlled prevention trial will test the extent to which youth assigned to an online coached mindfulness program as compared to youth in a supportive attention comparison intervention and a no-intervention control condition will show reduced mNA and its two components -- stressor-independent and stressor-reactive momentary negative affect The mindfulness training will be implemented through mobile technology eg online program Investigating the efficacy of an online mode of delivery of mindfulness with support of a coach can advance the prevention of internalizing psychopathology in a manner that could be disseminated broadly Such technology would improve access to care for youth who can be easily identified as being vulnerable to internalizing problems due to having high levels of tNA
Mindfulness-based interventions have been found to reduce negative affect and internalizing symptoms in children and adolescents This study will evaluate changes in mNA as a transdiagnostic target of mindfulness-based training in youth at high risk ie high tNA for internalizing problems and the degree to which reductions in such mNA partially account for the effects of mindfulness training on internalizing outcomes in youth This randomized controlled prevention trial will test the extent to which youth assigned to an online coached mindfulness program as compared to youth in a supportive attention comparison intervention and a no-intervention control condition will show reduced mNA and its two components -- stressor-independent and stressor-reactive momentary negative affect The mindfulness training will be implemented through mobile technology eg online program Investigating the efficacy of an online mode of delivery of mindfulness with support of a coach can advance the prevention of internalizing psychopathology in a manner that could be disseminated broadly Such technology would improve access to care for youth who can be easily identified as being vulnerable to internalizing problems due to having high levels of tNA
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