Adolescent Mindfulness Mobile App Study (RCT)

Not Applicable

Completed

Conditions: Rumination
Depression
Anxiety
Self-Injurious Behavior

Interventions: Behavioral: Mindfulness App

Registration Number: NCT03900416

Lead Sponsor: Lawrence University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 152

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness App	Mindfulness App	Guided mindfulness exercises will be delivered via mobile app for three weeks.

Primary Outcome Measures

Name	Time	Method
Children's Response Styles Questionnaire	6 months post intervention	trait rumination (range = 0-39 with higher scores indicating more rumination)
Children's Depression Inventory	6 months post intervention	self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Pediatric Symptom Checklist Internalizing Scale	6 months post intervention	parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
State Rumination	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)
Daily App Use	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.
State Mood	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)
Multidimensional Anxiety Scale for Children	6 months post intervention	self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Continued Use	6 months post intervention	Number of times app was used after the 3 week intervention period
Self-injurious Thoughts and Behaviors Questionnaire	6 months post intervention	percent of time engaged in self-injury over the past 3 months
Ease of Use	3 weeks (i.e., immediately post-intervention)	how easy app was to use (range = 1-7 with higher being easier to use)

Secondary Outcome Measures

Name	Time	Method
Five Facet Mindfulness Questionnaire Nonreactivity Subscale	6 months post intervention)	trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)
Five Facet Mindfulness Questionnaire Observing Subscale	6 months post intervention	trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)
Five Facet Mindfulness Questionnaire Describing Subscale	6 months post intervention	trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)
Five Facet Mindfulness Questionnaire Nonjudging Subscale	6 months post intervention	trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)
State Mindfulness Bodily Sensations	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)
Five Facet Mindfulness Questionnaire Awareness Subscale	6 months post intervention	trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)
State Mindfulness Present Focus	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