- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03900416
Adolescent Mindfulness Mobile App Study (RCT) (AMMASRCT)
Mindfulness-based Mobile Application to Reduce Rumination in Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rumination, a perseverative cognitive process that involves dwelling on negative emotions, is a transdiagnostic risk factor for the development of depression, anxiety, and self-injurious behaviors. Thus, reducing the tendency to ruminate in adolescence, a time when many psychological disorders often first develop, has the potential for a large public health impact. This protocol involves testing the acceptability and efficacy of a newly developed mindfulness mobile application designed to reduce rumination.
Mindfulness involves paying attention to the present moment without judgement. If negative emotions arise, one notices them and how the body is feeling without becoming caught up in the emotion so that it can pass. In adult clinical studies, intensive mindfulness practice has been associated with successful treatment of psychopathology, including preventing the recurrence of depression, possibly through reducing rumination. Research with adolescents has suggested that a brief mindfulness exercise can interrupt the ruminative process. Thus, mindfulness appears to be a promising strategy to reduce the tendency to ruminate and prevent psychopathology.
A diverse sample of 150 high-ruminating 12-15 year-olds will be recruited from the community and randomly assigned to a 3-week mobile mindfulness intervention or an ecological momentary assessment (EMA)-only control condition. In both conditions, adolescents will be notified to use the mobile app three times per day to complete EMA questions. Based on mood ratings, participants in the mindfulness condition have a chance to receive a brief mindfulness exercise (i.e., 1-12 minutes long) at each use. At pre- and post-intervention and three follow-up periods (6 weeks,12 weeks, and 6 months), participants and their parents will report on adolescent anxiety and depression. Adolescents will also report on self-injurious thoughts and behaviors (SITBs), trait rumination, and mindfulness. During the intervention period, participants will report on state levels of rumination, mindfulness, and mood using the app. Participants will also report on their satisfaction with the app, while their optional continued use of the app will be monitored electronically for 6 months following the intervention period. The investigators will test intervention effects using multilevel modeling, examining the role of both state- and trait-level mediators. Based on preliminary pilot data, the investigators expect that the mindfulness intervention will reduce symptoms, and we anticipate this effect to be due to the mediating role of decreased rumination.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
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Appleton, Wisconsin, United States, 54911
- Lawrence University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adolescent between the ages of 12 and 15 years
- at least moderate levels of rumination (mean score of 2 or above on a 1-4 scale) on the two screening questions
Exclusion Criteria:
- serious physical or cognitive disability that prevents adolescent from using a mobile device, because that is the intervention delivery method
- inadequate English proficiency to complete questionnaires
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness App
Guided mindfulness exercises will be delivered via mobile app for three weeks.
|
Mindfulness exercises will last 1-12 minutes.
Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
|
No Intervention: Control condition
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's Response Styles Questionnaire
Time Frame: baseline
|
trait rumination (range = 0-39 with higher scores indicating more rumination)
|
baseline
|
Children's Response Styles Questionnaire
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
trait rumination (range = 0-39 with higher scores indicating more rumination)
|
3 weeks (i.e., immediately post-intervention)
|
Children's Response Styles Questionnaire
Time Frame: 6 weeks post intervention
|
trait rumination (range = 0-39 with higher scores indicating more rumination)
|
6 weeks post intervention
|
Children's Response Styles Questionnaire
Time Frame: 12 weeks post intervention
|
trait rumination (range = 0-39 with higher scores indicating more rumination)
|
12 weeks post intervention
|
Children's Response Styles Questionnaire
Time Frame: 6 months post intervention
|
trait rumination (range = 0-39 with higher scores indicating more rumination)
|
6 months post intervention
|
Children's Depression Inventory
Time Frame: baseline
|
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
|
baseline
|
Children's Depression Inventory
Time Frame: 3 weeks (immediately post-intervention)
|
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
|
3 weeks (immediately post-intervention)
|
Children's Depression Inventory
Time Frame: 6 weeks post intervention
|
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
|
6 weeks post intervention
|
Children's Depression Inventory
Time Frame: 12 weeks post intervention
|
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
|
12 weeks post intervention
|
Children's Depression Inventory
Time Frame: 6 months post intervention
|
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
|
6 months post intervention
|
Multidimensional Anxiety Scale for Children
Time Frame: baseline
|
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
|
baseline
|
Multidimensional Anxiety Scale for Children
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
|
3 weeks (i.e., immediately post-intervention)
|
Multidimensional Anxiety Scale for Children
Time Frame: 6 weeks post intervention
|
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
|
6 weeks post intervention
|
Multidimensional Anxiety Scale for Children
Time Frame: 12 weeks post intervention
|
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
|
12 weeks post intervention
|
Multidimensional Anxiety Scale for Children
Time Frame: 6 months post intervention
|
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
|
6 months post intervention
|
Self-injurious Thoughts and Behaviors Questionnaire
Time Frame: baseline
|
percent of participants engaged in self-injury over the past year
|
baseline
|
Self-injurious Thoughts and Behaviors Questionnaire
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
percent of participants that engaged in self-injury over the past 3 weeks
|
3 weeks (i.e., immediately post-intervention)
|
Self-injurious Thoughts and Behaviors Questionnaire
Time Frame: 6 weeks post intervention
|
percent of participants that engaged in self-injury over the past 6 weeks
|
6 weeks post intervention
|
Self-injurious Thoughts and Behaviors Questionnaire
Time Frame: 12 weeks post intervention
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percent of time engaged in self-injury over the past 6 weeks
|
12 weeks post intervention
|
Self-injurious Thoughts and Behaviors Questionnaire
Time Frame: 6 months post intervention
|
percent of time engaged in self-injury over the past 3 months
|
6 months post intervention
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Pediatric Symptom Checklist Internalizing Scale
Time Frame: baseline
|
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
|
baseline
|
Pediatric Symptom Checklist Internalizing Scale
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
|
3 weeks (i.e., immediately post-intervention)
|
Pediatric Symptom Checklist Internalizing Scale
Time Frame: 6 weeks post intervention
|
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
|
6 weeks post intervention
|
Pediatric Symptom Checklist Internalizing Scale
Time Frame: 12 weeks post intervention
|
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
|
12 weeks post intervention
|
Pediatric Symptom Checklist Internalizing Scale
Time Frame: 6 months post intervention
|
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
|
6 months post intervention
|
State Rumination
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
average state rumination during intervention period rated on a visual analog scale (range = 0-100 with higher scores indicating more rumination)
|
3 weeks (i.e., immediately post-intervention)
|
State Mood
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
average sadness and anxiety during intervention period rated on visual analog scales (range = 0-100 with higher scores indicating more rumination)
|
3 weeks (i.e., immediately post-intervention)
|
Daily App Use
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
Daily app use was determined by how many complete app uses were logged during the three-week intervention period.
|
3 weeks (i.e., immediately post-intervention)
|
Continued Use
Time Frame: 6 months post intervention
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Number of times app was used after the 3 week intervention period
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6 months post intervention
|
Ease of Use
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
how easy app was to use (range = 1-7 with higher being easier to use)
|
3 weeks (i.e., immediately post-intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Five Facet Mindfulness Questionnaire Observing Subscale
Time Frame: baseline
|
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
|
baseline
|
Five Facet Mindfulness Questionnaire Observing Subscale
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
|
3 weeks (i.e., immediately post-intervention)
|
Five Facet Mindfulness Questionnaire Observing Subscale
Time Frame: 6 weeks post intervention
|
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
|
6 weeks post intervention
|
Five Facet Mindfulness Questionnaire Observing Subscale
Time Frame: 12 weeks post intervention
|
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
|
12 weeks post intervention
|
Five Facet Mindfulness Questionnaire Observing Subscale
Time Frame: 6 months post intervention
|
trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
|
6 months post intervention
|
Five Facet Mindfulness Questionnaire Describing Subscale
Time Frame: baseline
|
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
|
baseline
|
Five Facet Mindfulness Questionnaire Describing Subscale
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
|
3 weeks (i.e., immediately post-intervention)
|
Five Facet Mindfulness Questionnaire Describing Subscale
Time Frame: 6 weeks post intervention
|
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
|
6 weeks post intervention
|
Five Facet Mindfulness Questionnaire Describing Subscale
Time Frame: 12 weeks post intervention
|
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
|
12 weeks post intervention
|
Five Facet Mindfulness Questionnaire Describing Subscale
Time Frame: 6 months post intervention
|
trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
|
6 months post intervention
|
Five Facet Mindfulness Questionnaire Awareness Subscale
Time Frame: baseline
|
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
|
baseline
|
Five Facet Mindfulness Questionnaire Awareness Subscale
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
|
3 weeks (i.e., immediately post-intervention)
|
Five Facet Mindfulness Questionnaire Awareness Subscale
Time Frame: 6 weeks post intervention
|
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
|
6 weeks post intervention
|
Five Facet Mindfulness Questionnaire Awareness Subscale
Time Frame: 12 weeks post intervention
|
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
|
12 weeks post intervention
|
Five Facet Mindfulness Questionnaire Awareness Subscale
Time Frame: 6 months post intervention
|
trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
|
6 months post intervention
|
Five Facet Mindfulness Questionnaire Nonjudging Subscale
Time Frame: baseline
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trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
|
baseline
|
Five Facet Mindfulness Questionnaire Nonjudging Subscale
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
|
3 weeks (i.e., immediately post-intervention)
|
Five Facet Mindfulness Questionnaire Nonjudging Subscale
Time Frame: 6 weeks post intervention
|
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
|
6 weeks post intervention
|
Five Facet Mindfulness Questionnaire Nonjudging Subscale
Time Frame: 12 weeks post intervention
|
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
|
12 weeks post intervention
|
Five Facet Mindfulness Questionnaire Nonjudging Subscale
Time Frame: 6 months post intervention
|
trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
|
6 months post intervention
|
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
Time Frame: baseline
|
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
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baseline
|
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
|
3 weeks (i.e., immediately post-intervention)
|
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
Time Frame: 6 weeks post intervention)
|
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
|
6 weeks post intervention)
|
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
Time Frame: 12 weeks post intervention)
|
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
|
12 weeks post intervention)
|
Five Facet Mindfulness Questionnaire Nonreactivity Subscale
Time Frame: 6 months post intervention)
|
trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
|
6 months post intervention)
|
State Mindfulness Bodily Sensations
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
average focus on bodily sensations during intervention period rated on visual analog scale (range = 0-100 with higher scores indicating more mindfulness)
|
3 weeks (i.e., immediately post-intervention)
|
State Mindfulness Present Focus
Time Frame: 3 weeks (i.e., immediately post-intervention)
|
average % focus on present moment (as opposed to past or future focus) during intervention period indicating more mindfulness
|
3 weeks (i.e., immediately post-intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lori M Hilt, PhD, Lawrence University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7_25_18_Hilt
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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