Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents
ConditionRumination
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorMclean Hospital
About this trial
A growing body of research implicates rumination as being a transdiagnostic risk factor involved in the development of depression and anxiety in youth. Critically, mindfulness meditation has shown significant promise in targeting rumination, and ultimately improving depressive and anxiety symptoms. Mindfulness apps offer a convenient and cost-effective means for accessing mindfulness training, while being interactive and engaging for youth. Despite their growing popularity among teens, strikingly little research has been conducted on these apps. Two critical questions have yet to be addressed: (1) what are the underlying neural and cognitive mechanisms that account for the beneficial effects of these apps and (2) for whom is app-based mindfulness well-suited. To address these gaps, adolescents (ages 13-18) will be randomly assigned to an app-delivered mindfulness course vs. a control condition and will complete pre- and post-intervention resting state functional magnetic resonance imaging (fMRI) scans to probe static and dynamic functional connectivity within - and between - brain networks strongly implicated in mindfulness training and rumination. In addition, cognitive tasks will be administered at pre- and post-intervention to assess attentional control abilities putatively enhanced by mindfulness training. Finally, mindfulness skills and changes in rumination will be assessed via smartphone-based ecological momentary assessment (EMA). First, the investigators will test whether changes in (1) brain functional connectivity, (2) attentional control and (3) acquisition and use of mindfulness skills mediate between-group (i.e., app vs. control) differences in the reduction of rumination. Second, the investigators will test whether a machine learning model incorporating baseline clinical, demographic, and psychosocial characteristics can be used to identify which adolescents are predicted to benefit from app-based mindfulness training.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Both genders, all ethnicities (see Section: Inclusion of Women and Minorities)
Ages 13-18 years
Written informed assent/consent from adolescent and parent/guardian
English as a first language or English fluency
Disqualifiers
History or current diagnosis of any of the following DSM-5 disorders: schizophrenia spectrum or other psychotic disorder, bipolar disorder, substance/alcohol use disorder within the past 12 months or lifetime severe substance/alcohol use disorder.
Systemic medical or neurological illness that could impact fMRI measures of cerebral blood flow
Failure to meet standard exclusion criteria for fMRI scanning (e.g. pregnancy, claustrophobia, cardiac or neural pacemakers, surgically implanted metal devices, cochlear implants, metal objects in the body)
History of seizure disorder, or head trauma with loss of consciousness > 2 mins
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness (Headspace) App
BehavioralThe Headspace app consists of guided mindfulness meditations and is available for both Apple iOS and Android devices. For the proposed study, participants will be instructed to complete the app's most popular introductory program which consists of three levels ("Basics 1-3"), with each level comprising 10 sessions (30 in total) over 30 days. The program is intended to introduce the key principles and techniques of mindfulness (including focused meditation on the breath, body scanning, and noting), and strategies for applying mindfulness to daily life.
Active Control Condition ("Recharge" condition delivered in Headspace app)
BehavioralThe majority of prior research on mindfulness interventions has relied on single-arm designs or wait-list controls conditions, rather than active control conditions. Accordingly, we will include a structurally-equivalent active control condition, delivered via the same Headspace app. Specifically, the control condition will consist of 30 guided "Recharge" sessions led by Andy Puddicombe (i.e., structurally equivalent to the Mindfulness app). The sessions are the same length as the interventions (Basics) sessions and also delivered via the Headspace app, thus closely matching the mindfulness intervention across key attributes. Specifically, user flow through the app is identical in both the mindfulness and control conditions, differing only in session content. The Recharge sessions include guide reflections, guided positive imagery, problem solving and daily planning. The chosen excerpts exclude any content which feature guided mindfulness exercises.
Treatment groups
158 Participants
are divided into 2 treatment groupsGroup A: Mindfulness (Headspace app)Experimental treatment 1 intervention
Group B: Active Control ConditionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Slope of change in rumination scores (assessed via smartphone-delivered ecological momentary assessment items derived from rumination measure [unnamed] developed by Ruscio et al., J Abnorm Psychol, 2015 and used in Webb et al., J Am Acad Child Psy, 2021)
Time frame
30 weeksSponsors and contacts
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Source ClinicalTrials.gov