Clinical trial NCT03900416: Adolescent Mindfulness Mobile App Study (RCT)
Official title: Mindfulness-based Mobile Application to Reduce Rumination in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rumination
Depression
Anxiety
Self-Injurious Behavior
Keywords: Mindfulness
Mobile Intervention
Brief Intervention
Adolescence
Lead sponsor: Lawrence University
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 152
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Children's Response Styles Questionnaire
timeFrame: baseline
measure: Children's Response Styles Questionnaire
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: Children's Response Styles Questionnaire
timeFrame: 6 weeks post intervention
measure: Children's Response Styles Questionnaire
timeFrame: 12 weeks post intervention
measure: Children's Response Styles Questionnaire
timeFrame: 6 months post intervention
measure: Children's Depression Inventory
timeFrame: baseline
measure: Children's Depression Inventory
timeFrame: 3 weeks (immediately post-intervention)
measure: Children's Depression Inventory
timeFrame: 6 weeks post intervention
measure: Children's Depression Inventory
timeFrame: 12 weeks post intervention
measure: Children's Depression Inventory
timeFrame: 6 months post intervention
measure: Multidimensional Anxiety Scale for Children
timeFrame: baseline
measure: Multidimensional Anxiety Scale for Children
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: Multidimensional Anxiety Scale for Children
timeFrame: 6 weeks post intervention
measure: Multidimensional Anxiety Scale for Children
timeFrame: 12 weeks post intervention
measure: Multidimensional Anxiety Scale for Children
timeFrame: 6 months post intervention
measure: Self-injurious Thoughts and Behaviors Questionnaire
timeFrame: baseline
measure: Self-injurious Thoughts and Behaviors Questionnaire
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: Self-injurious Thoughts and Behaviors Questionnaire
timeFrame: 6 weeks post intervention
measure: Self-injurious Thoughts and Behaviors Questionnaire
timeFrame: 12 weeks post intervention
measure: Self-injurious Thoughts and Behaviors Questionnaire
timeFrame: 6 months post intervention
measure: Pediatric Symptom Checklist Internalizing Scale
timeFrame: baseline
measure: Pediatric Symptom Checklist Internalizing Scale
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: Pediatric Symptom Checklist Internalizing Scale
timeFrame: 6 weeks post intervention
measure: Pediatric Symptom Checklist Internalizing Scale
timeFrame: 12 weeks post intervention
measure: Pediatric Symptom Checklist Internalizing Scale
timeFrame: 6 months post intervention
measure: State Rumination
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: State Mood
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: Daily App Use
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: Continued Use
timeFrame: 6 months post intervention
measure: Ease of Use
timeFrame: 3 weeks (i.e., immediately post-intervention)
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire Observing Subscale
timeFrame: baseline
measure: Five Facet Mindfulness Questionnaire Observing Subscale
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: Five Facet Mindfulness Questionnaire Observing Subscale
timeFrame: 6 weeks post intervention
measure: Five Facet Mindfulness Questionnaire Observing Subscale
timeFrame: 12 weeks post intervention
measure: Five Facet Mindfulness Questionnaire Observing Subscale
timeFrame: 6 months post intervention
measure: Five Facet Mindfulness Questionnaire Describing Subscale
timeFrame: baseline
measure: Five Facet Mindfulness Questionnaire Describing Subscale
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: Five Facet Mindfulness Questionnaire Describing Subscale
timeFrame: 6 weeks post intervention
measure: Five Facet Mindfulness Questionnaire Describing Subscale
timeFrame: 12 weeks post intervention
measure: Five Facet Mindfulness Questionnaire Describing Subscale
timeFrame: 6 months post intervention
measure: Five Facet Mindfulness Questionnaire Awareness Subscale
timeFrame: baseline
measure: Five Facet Mindfulness Questionnaire Awareness Subscale
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: Five Facet Mindfulness Questionnaire Awareness Subscale
timeFrame: 6 weeks post intervention
measure: Five Facet Mindfulness Questionnaire Awareness Subscale
timeFrame: 12 weeks post intervention
measure: Five Facet Mindfulness Questionnaire Awareness Subscale
timeFrame: 6 months post intervention
measure: Five Facet Mindfulness Questionnaire Nonjudging Subscale
timeFrame: baseline
measure: Five Facet Mindfulness Questionnaire Nonjudging Subscale
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: Five Facet Mindfulness Questionnaire Nonjudging Subscale
timeFrame: 6 weeks post intervention
measure: Five Facet Mindfulness Questionnaire Nonjudging Subscale
timeFrame: 12 weeks post intervention
measure: Five Facet Mindfulness Questionnaire Nonjudging Subscale
timeFrame: 6 months post intervention
measure: Five Facet Mindfulness Questionnaire Nonreactivity Subscale
timeFrame: baseline
measure: Five Facet Mindfulness Questionnaire Nonreactivity Subscale
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: Five Facet Mindfulness Questionnaire Nonreactivity Subscale
timeFrame: 6 weeks post intervention)
measure: Five Facet Mindfulness Questionnaire Nonreactivity Subscale
timeFrame: 12 weeks post intervention)
measure: Five Facet Mindfulness Questionnaire Nonreactivity Subscale
timeFrame: 6 months post intervention)
measure: State Mindfulness Bodily Sensations
timeFrame: 3 weeks (i.e., immediately post-intervention)
measure: State Mindfulness Present Focus
timeFrame: 3 weeks (i.e., immediately post-intervention)
Other outcomes:
Locations:
city: Appleton
country: United States
facility: Lawrence University
state: Wisconsin
Study officials:
affiliation: Lawrence University
name: Lori M Hilt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Webb CA, Swords CM, Lawrence HR, Hilt LM. Which adolescents are well-suited to app-based mindfulness training? A randomized clinical trial and data-driven approach for personalized recommendations. J Consult Clin Psychol. 2022 Sep;90(9):655-669. doi: 10.1037/ccp0000763.