Adolescent Mindfulness Mobile App Study (RCT)
Condition: Rumination; Depression; Anxiety; Self-Injurious Behavior
MeSH terms: Rumination Syndrome; Self-Injurious Behavior
Study type: Interventional

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.
    

Intervention name(s): Mindfulness App
Intervention type(s): Behavioral
Intervention description(s): Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Prevention
Keywords: Mindfulness; Mobile Intervention; Brief Intervention; Adolescence