Adolescent Mindfulness Mobile App Study (RCT)

Study Overview
=================
Brief Summary
-----------------
Rumination involves focusing on negative emotions repeatedly and is a risk factor for developing depression, anxiety, and self-injury. These negative outcomes increase in adolescence. The main goal of this study is to examine whether a mobile application designed to reduce rumination works with adolescents. The mobile application involves mindfulness exercises. Mindfulness means nonjudgmentally and deliberately paying attention. Adolescents will be randomly assigned to either the mindfulness group or a control group who uses a mobile application without mindfulness exercises. Both groups will use the app three times per day for three weeks and we will follow up with participants for six months. The investigators hypothesize that the mindfulness group will experience a reduction in rumination and symptoms of depression, anxiety and self-injury. They also expect that the mindfulness group will find the mobile app to be more engaging and will continue to use it beyond the 3 weeks.

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.

Official Title
-----------------
Mindfulness-based Mobile Application to Reduce Rumination in Adolescents

Conditions
-----------------
Rumination, Depression, Anxiety, Self-Injurious Behavior

Intervention / Treatment
-----------------
* Behavioral: Mindfulness App


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to the intervention group (i.e., mindfulness with ecological momentary assessment) or the control group (i.e., ecological momentary assessment only).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness App<br>Guided mindfulness exercises will be delivered via mobile app for three weeks. | Behavioral: Mindfulness App<br>* Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.<br>|
| No Intervention: Control condition<br>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 | trait rumination (range = 0-39 with higher scores indicating more rumination) | baseline | 
| Children's Response Styles Questionnaire | trait rumination (range = 0-39 with higher scores indicating more rumination) | 3 weeks (i.e., immediately post-intervention) | 
| Children's Response Styles Questionnaire | trait rumination (range = 0-39 with higher scores indicating more rumination) | 6 weeks post intervention | 
| Children's Response Styles Questionnaire | trait rumination (range = 0-39 with higher scores indicating more rumination) | 12 weeks post intervention | 
| Children's Response Styles Questionnaire | trait rumination (range = 0-39 with higher scores indicating more rumination) | 6 months post intervention | 
| Children's Depression Inventory | self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms) | baseline | 
| Children's Depression Inventory | self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms) | 3 weeks (immediately post-intervention) | 
| Children's Depression Inventory | self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms) | 6 weeks post intervention | 
| Children's Depression Inventory | self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms) | 12 weeks post intervention | 
| Children's Depression Inventory | self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms) | 6 months post intervention | 
| Multidimensional Anxiety Scale for Children | self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety) | baseline | 
| Multidimensional Anxiety Scale for Children | 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 | self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety) | 6 weeks post intervention | 
| Multidimensional Anxiety Scale for Children | self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety) | 12 weeks post intervention | 
| Multidimensional Anxiety Scale for Children | self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety) | 6 months post intervention | 
| Self-injurious Thoughts and Behaviors Questionnaire | percent of participants engaged in self-injury over the past year | baseline | 
| Self-injurious Thoughts and Behaviors Questionnaire | 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 | percent of participants that engaged in self-injury over the past 6 weeks | 6 weeks post intervention | 
| Self-injurious Thoughts and Behaviors Questionnaire | percent of time engaged in self-injury over the past 6 weeks | 12 weeks post intervention | 
| Self-injurious Thoughts and Behaviors Questionnaire | percent of time engaged in self-injury over the past 3 months | 6 months post intervention | 
| Pediatric Symptom Checklist Internalizing Scale | parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms) | baseline | 
| Pediatric Symptom Checklist Internalizing Scale | 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 | parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms) | 6 weeks post intervention | 
| Pediatric Symptom Checklist Internalizing Scale | parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms) | 12 weeks post intervention | 
| Pediatric Symptom Checklist Internalizing Scale | parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms) | 6 months post intervention | 
| State Rumination | 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 | 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 | 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 | Number of times app was used after the 3 week intervention period | 6 months post intervention | 
| Ease of Use | how easy app was to use (range = 1-7 with higher being easier to use) | 3 weeks (i.e., immediately post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five Facet Mindfulness Questionnaire Observing Subscale | trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness) | baseline | 
| Five Facet Mindfulness Questionnaire Observing Subscale | 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 | trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness) | 6 weeks post intervention | 
| Five Facet Mindfulness Questionnaire Observing Subscale | trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness) | 12 weeks post intervention | 
| Five Facet Mindfulness Questionnaire Observing Subscale | trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness) | 6 months post intervention | 
| Five Facet Mindfulness Questionnaire Describing Subscale | trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness) | baseline | 
| Five Facet Mindfulness Questionnaire Describing Subscale | 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 | trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness) | 6 weeks post intervention | 
| Five Facet Mindfulness Questionnaire Describing Subscale | trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness) | 12 weeks post intervention | 
| Five Facet Mindfulness Questionnaire Describing Subscale | trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness) | 6 months post intervention | 
| Five Facet Mindfulness Questionnaire Awareness Subscale | trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness) | baseline | 
| Five Facet Mindfulness Questionnaire Awareness Subscale | 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 | trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness) | 6 weeks post intervention | 
| Five Facet Mindfulness Questionnaire Awareness Subscale | trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness) | 12 weeks post intervention | 
| Five Facet Mindfulness Questionnaire Awareness Subscale | trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness) | 6 months post intervention | 
| Five Facet Mindfulness Questionnaire Nonjudging Subscale | trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness) | baseline | 
| Five Facet Mindfulness Questionnaire Nonjudging Subscale | 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 | 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 | 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 | 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 | trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness) | baseline | 
| Five Facet Mindfulness Questionnaire Nonreactivity Subscale | 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 | 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 | 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 | trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness) | 6 months post intervention) | 
| State Mindfulness Bodily Sensations | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mindfulness, Mobile Intervention, Brief Intervention, Adolescence