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Adolescent Mindfulness Mobile App Study (RCT) (AMMASRCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03900416
Recruitment Status : Active, not recruiting
First Posted : April 3, 2019
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Lori Hilt, 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.

Condition or disease Intervention/treatment Phase
Rumination Depression Anxiety Self-Injurious Behavior Behavioral: Mindfulness App Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
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
Official Title: Mindfulness-based Mobile Application to Reduce Rumination in Adolescents
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Mindfulness App
Guided mindfulness exercises will be delivered via mobile app for three weeks.
Behavioral: Mindfulness App
Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.

No Intervention: Control condition
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.



Primary Outcome Measures :
  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 time 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 time engaged in self-injury over the past 3 weeks

  18. Self-injurious Thoughts and Behaviors Questionnaire [ Time Frame: 6 weeks post intervention ]
    percent of time 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) ]
    how often app is used during the 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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900416


Locations
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United States, Wisconsin
Lawrence University
Appleton, Wisconsin, United States, 54911
Sponsors and Collaborators
Lawrence University
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Responsible Party: Lori Hilt, Associate Professor of Psychology, Lawrence University
ClinicalTrials.gov Identifier: NCT03900416    
Other Study ID Numbers: 7_25_18_Hilt
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lori Hilt, Lawrence University:
Mindfulness
Mobile Intervention
Brief Intervention
Adolescence
Additional relevant MeSH terms:
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Self-Injurious Behavior
Behavioral Symptoms