N/A
N=152
Adolescent Mindfulness Mobile App Study (RCT)
Rumination · Depression · Anxiety · Self-Injurious Behavior
Bottom Line
View on ClinicalTrials.gov: NCT03900416 ↗Enrolled (actual)
152
Serious AEs
0.7%
Results posted
Nov 2021
Primary outcome: Primary: Children's Response Styles Questionnaire — 33.47; 30.73 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness App (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Lawrence University
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children's Response Styles Questionnaire |
29.4; 29.77 | — |
| PRIMARY Children's Response Styles Questionnaire |
29.4; 29.77 | — |
| PRIMARY Children's Response Styles Questionnaire |
29.4; 29.77 | — |
| PRIMARY Children's Response Styles Questionnaire |
29.4; 29.77 | — |
| PRIMARY Children's Response Styles Questionnaire |
29.4; 29.77 | — |
| PRIMARY Children's Depression Inventory |
8.84; 10.42 | — |
| PRIMARY Children's Depression Inventory |
8.84; 10.42 | — |
| PRIMARY Children's Depression Inventory |
8.84; 10.42 | — |
| PRIMARY Children's Depression Inventory |
8.84; 10.42 | — |
| PRIMARY Children's Depression Inventory |
8.84; 10.42 | — |
| PRIMARY Multidimensional Anxiety Scale for Children |
49.29; 49.56 | — |
| PRIMARY Multidimensional Anxiety Scale for Children |
49.29; 49.56 | — |
| PRIMARY Multidimensional Anxiety Scale for Children |
49.29; 49.56 | — |
| PRIMARY Multidimensional Anxiety Scale for Children |
49.29; 49.56 | — |
| PRIMARY Multidimensional Anxiety Scale for Children |
49.29; 49.56 | — |
| PRIMARY Self-injurious Thoughts and Behaviors Questionnaire |
3; 2 | — |
| PRIMARY Self-injurious Thoughts and Behaviors Questionnaire |
3; 2 | — |
| PRIMARY Self-injurious Thoughts and Behaviors Questionnaire |
3; 2 | — |
| PRIMARY Self-injurious Thoughts and Behaviors Questionnaire |
3; 2 | — |
| PRIMARY Self-injurious Thoughts and Behaviors Questionnaire |
3; 2 | — |
| PRIMARY Pediatric Symptom Checklist Internalizing Scale |
2.38; 2.68 | — |
| PRIMARY Pediatric Symptom Checklist Internalizing Scale |
2.38; 2.68 | — |
| PRIMARY Pediatric Symptom Checklist Internalizing Scale |
2.38; 2.68 | — |
| PRIMARY Pediatric Symptom Checklist Internalizing Scale |
2.38; 2.68 | — |
| PRIMARY Pediatric Symptom Checklist Internalizing Scale |
2.38; 2.68 | — |
| PRIMARY State Rumination |
41.88; 42.53; 34.80; 37.58 | — |
| PRIMARY State Mood |
36.62; 39.08; 25.00; 25.02 | — |
| PRIMARY Daily App Use |
51.72; 54.26 | — |
| PRIMARY Continued Use |
40.24; 39.74 | — |
| PRIMARY Ease of Use |
6.13; 6.27 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Observing Subscale |
24.19; 21.48 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Observing Subscale |
24.19; 21.48 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Observing Subscale |
24.19; 21.48 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Observing Subscale |
24.19; 21.48 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Observing Subscale |
24.19; 21.48 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Describing Subscale |
25.56; 24.97 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Describing Subscale |
25.56; 24.97 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Describing Subscale |
25.56; 24.97 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Describing Subscale |
25.56; 24.97 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Describing Subscale |
25.56; 24.97 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Awareness Subscale |
25.43; 26.07 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Awareness Subscale |
25.43; 26.07 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Awareness Subscale |
25.43; 26.07 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Awareness Subscale |
25.43; 26.07 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Awareness Subscale |
25.43; 26.07 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Nonjudging Subscale |
28.87; 28.01 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Nonjudging Subscale |
28.87; 28.01 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Nonjudging Subscale |
28.87; 28.01 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Nonjudging Subscale |
28.87; 28.01 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Nonjudging Subscale |
28.87; 28.01 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Nonreactivity Subscale |
21.3; 20.03 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Nonreactivity Subscale |
21.3; 20.03 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Nonreactivity Subscale |
21.3; 20.03 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Nonreactivity Subscale |
21.3; 20.03 | — |
| SECONDARY Five Facet Mindfulness Questionnaire Nonreactivity Subscale |
21.3; 20.03 | — |
| SECONDARY State Mindfulness Bodily Sensations |
36.59; 38.67 | — |
| SECONDARY State Mindfulness Present Focus |
.633; .558 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03900416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.