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Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents

Primary Purpose

Rumination

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness (Headspace) App
Active Control Condition ("Recharge" condition delivered in Headspace app)
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rumination

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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
  • Right-handed
  • Personal iPhone or Android smartphone
  • CRSQ rumination subscale score
  • If on psychotropic medication, must be on stable dose for at least 2 months

Exclusion Criteria:

  • 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
  • Serious or unstable medical illness (e.g., cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease)
  • Participants with active suicidal ideation will be immediately referred to appropriate clinical treatment.
  • Current or past treatment with mindfulness-based psychotherapy (e.g., MBCT, DBT or ACT)
  • Exposure to in-person or app-based mindfulness/meditation course (at least 300 mins of past practice)

Sites / Locations

  • McLean HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness (Headspace app)

Active Control Condition

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
January 4, 2021
Last Updated
March 16, 2023
Sponsor
Mclean Hospital
Collaborators
Cambridge Health Alliance, Lawrence University
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1. Study Identification

Unique Protocol Identification Number
NCT04697966
Brief Title
Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents
Official Title
Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
Cambridge Health Alliance, Lawrence University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Mindfulness-based smartphone apps have surged in popularity in recent years. Headspace - among the most popular of these platforms - has over 42 million users. Recent surveys indicate that 11% of U.S. adolescents have used mindfulness apps as a means of coping with anxiety or depressive symptoms, which increase substantially during the adolescent years. 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, which are strongly aligned with the NCCIH Strategic Plan: (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. an active 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 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 (dynamic resting state functional connectivity via coactivation pattern analysis), (2) attentional control (Correct NoGo % on the SART task) and (3) acquisition and use of mindfulness skills (assessed via EMA) 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. Ultimately, such an algorithm may inform individual risk-benefit assessments that could be used to objectively communicate the probability of experiencing positive vs. adverse outcomes to users prior to engaging with a mindfulness app. Collectively, results are expected to advance (1) our understanding of the underlying mechanisms that account for the beneficial effects of app-based mindfulness training and (2) our ability to predict which adolescents are well-suited to these increasingly popular apps.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rumination

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness (Headspace app)
Arm Type
Experimental
Arm Title
Active Control Condition
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness (Headspace) App
Intervention Description
The 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.
Intervention Type
Behavioral
Intervention Name(s)
Active Control Condition ("Recharge" condition delivered in Headspace app)
Intervention Description
The 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.
Primary Outcome Measure Information:
Title
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 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Right-handed Personal iPhone or Android smartphone CRSQ rumination subscale score If on psychotropic medication, must be on stable dose for at least 2 months Exclusion Criteria: 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 Serious or unstable medical illness (e.g., cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease) Participants with active suicidal ideation will be immediately referred to appropriate clinical treatment. Current or past treatment with mindfulness-based psychotherapy (e.g., MBCT, DBT or ACT) Exposure to in-person or app-based mindfulness/meditation course (at least 300 mins of past practice)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Webb, Phd
Phone
6178554429
Email
cwebb@mclean.harvard.edu
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian A Webb, Phd

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Yes. We will share via the National Institute of Mental Health Data Archive (NDA)

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Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents

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