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Completed

NCT Number: NCT03900416

Adolescent Mindfulness Mobile App Study (RCT)

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.

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Key information

Conditions

Rumination Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Digestive System Diseases Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders Rumination Syndrome Self-Injurious Behavior

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lawrence University

Appleton, Wisconsin, 54911, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness App

Behavioral

Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.

Primary outcomes

  1. Children's Response Styles Questionnaire

    Time frame: baseline

    trait rumination (range = 0-39 with higher scores indicating more rumination)

  2. 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. Children's Response Styles Questionnaire

    Time frame: 6 weeks post intervention

    trait rumination (range = 0-39 with higher scores indicating more rumination)

  4. Children's Response Styles Questionnaire

    Time frame: 12 weeks post intervention

    trait rumination (range = 0-39 with higher scores indicating more rumination)

  5. Children's Response Styles Questionnaire

    Time frame: 6 months post intervention

    trait rumination (range = 0-39 with higher scores indicating more rumination)

  6. Children's Depression Inventory

    Time frame: baseline

    self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)

  7. Children's Depression Inventory

    Time frame: 3 weeks (immediately post-intervention)

    self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)

  8. Children's Depression Inventory

    Time frame: 6 weeks post intervention

    self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)

  9. Children's Depression Inventory

    Time frame: 12 weeks post intervention

    self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)

  10. Children's Depression Inventory

    Time frame: 6 months post intervention

    self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)

  11. Multidimensional Anxiety Scale for Children

    Time frame: baseline

    self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)

  12. 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)

  13. Multidimensional Anxiety Scale for Children

    Time frame: 6 weeks post intervention

    self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)

  14. Multidimensional Anxiety Scale for Children

    Time frame: 12 weeks post intervention

    self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)

  15. Multidimensional Anxiety Scale for Children

    Time frame: 6 months post intervention

    self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)

  16. Self-injurious Thoughts and Behaviors Questionnaire

    Time frame: baseline

    percent of participants engaged in self-injury over the past year

  17. 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

  18. 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

  19. Self-injurious Thoughts and Behaviors Questionnaire

    Time frame: 12 weeks post intervention

    percent of time engaged in self-injury over the past 6 weeks

  20. Self-injurious Thoughts and Behaviors Questionnaire

    Time frame: 6 months post intervention

    percent of time engaged in self-injury over the past 3 months

  21. Pediatric Symptom Checklist Internalizing Scale

    Time frame: baseline

    parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

  26. 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)

  27. 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)

  28. 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.

  29. Continued Use

    Time frame: 6 months post intervention

    Number of times app was used after the 3 week intervention period

  30. 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)

Secondary outcomes

  1. Five Facet Mindfulness Questionnaire Observing Subscale

    Time frame: baseline

    trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)

  2. 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. Five Facet Mindfulness Questionnaire Observing Subscale

    Time frame: 6 weeks post intervention

    trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)

  4. Five Facet Mindfulness Questionnaire Observing Subscale

    Time frame: 12 weeks post intervention

    trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)

  5. 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. Five Facet Mindfulness Questionnaire Describing Subscale

    Time frame: baseline

    trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)

  7. 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)

  8. Five Facet Mindfulness Questionnaire Describing Subscale

    Time frame: 6 weeks post intervention

    trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)

  9. Five Facet Mindfulness Questionnaire Describing Subscale

    Time frame: 12 weeks post intervention

    trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)

  10. Five Facet Mindfulness Questionnaire Describing Subscale

    Time frame: 6 months post intervention

    trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)

  11. Five Facet Mindfulness Questionnaire Awareness Subscale

    Time frame: baseline

    trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. Five Facet Mindfulness Questionnaire Nonjudging Subscale

    Time frame: baseline

    trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)

  17. 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)

  18. 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)

  19. 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)

  20. 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)

  21. 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)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

  26. 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)

  27. 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

Sponsors and collaborators

Lead sponsor

Lawrence University

Other

Registry information

Official study title

Mindfulness-based Mobile Application to Reduce Rumination in Adolescents

Acronym: AMMASRCT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 3, 2019
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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