Mindfulness-based Mobile Application to Reduce Rumination in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Children's Response Styles Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mindfulness App
Guided mindfulness exercises will be delivered via mobile app for three weeks.
干预措施: Mindfulness App (Behavioral)
Control condition
Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.
结局指标
主要结局
Children's Response Styles Questionnaire
时间窗: 6 months post intervention
trait rumination (range = 0-39 with higher scores indicating more rumination)
Children's Depression Inventory
时间窗: 6 months post intervention
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Pediatric Symptom Checklist Internalizing Scale
时间窗: 6 months post intervention
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
State Rumination
时间窗: 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)
Daily App Use
时间窗: 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.
State Mood
时间窗: 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)
Multidimensional Anxiety Scale for Children
时间窗: 6 months post intervention
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Continued Use
时间窗: 6 months post intervention
Number of times app was used after the 3 week intervention period
Self-injurious Thoughts and Behaviors Questionnaire
时间窗: 6 months post intervention
percent of time engaged in self-injury over the past 3 months
Ease of Use
时间窗: 3 weeks (i.e., immediately post-intervention)
how easy app was to use (range = 1-7 with higher being easier to use)
Children's Response Styles Questionnaire
时间窗: baseline
trait rumination (range = 0-39 with higher scores indicating more rumination)
Children's Response Styles Questionnaire
时间窗: 3 weeks (i.e., immediately post-intervention)
trait rumination (range = 0-39 with higher scores indicating more rumination)
Children's Response Styles Questionnaire
时间窗: 6 weeks post intervention
trait rumination (range = 0-39 with higher scores indicating more rumination)
Children's Response Styles Questionnaire
时间窗: 12 weeks post intervention
trait rumination (range = 0-39 with higher scores indicating more rumination)
Children's Depression Inventory
时间窗: baseline
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Children's Depression Inventory
时间窗: 3 weeks (immediately post-intervention)
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Children's Depression Inventory
时间窗: 6 weeks post intervention
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Children's Depression Inventory
时间窗: 12 weeks post intervention
self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)
Multidimensional Anxiety Scale for Children
时间窗: baseline
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Multidimensional Anxiety Scale for Children
时间窗: 3 weeks (i.e., immediately post-intervention)
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Multidimensional Anxiety Scale for Children
时间窗: 6 weeks post intervention
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Multidimensional Anxiety Scale for Children
时间窗: 12 weeks post intervention
self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)
Self-injurious Thoughts and Behaviors Questionnaire
时间窗: baseline
percent of participants engaged in self-injury over the past year
Self-injurious Thoughts and Behaviors Questionnaire
时间窗: 3 weeks (i.e., immediately post-intervention)
percent of participants that engaged in self-injury over the past 3 weeks
Self-injurious Thoughts and Behaviors Questionnaire
时间窗: 6 weeks post intervention
percent of participants that engaged in self-injury over the past 6 weeks
Self-injurious Thoughts and Behaviors Questionnaire
时间窗: 12 weeks post intervention
percent of time engaged in self-injury over the past 6 weeks
Pediatric Symptom Checklist Internalizing Scale
时间窗: baseline
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Pediatric Symptom Checklist Internalizing Scale
时间窗: 3 weeks (i.e., immediately post-intervention)
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Pediatric Symptom Checklist Internalizing Scale
时间窗: 6 weeks post intervention
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
Pediatric Symptom Checklist Internalizing Scale
时间窗: 12 weeks post intervention
parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)
次要结局
- Five Facet Mindfulness Questionnaire Nonreactivity Subscale(6 months post intervention))
- Five Facet Mindfulness Questionnaire Observing Subscale(6 months post intervention)
- Five Facet Mindfulness Questionnaire Describing Subscale(6 months post intervention)
- Five Facet Mindfulness Questionnaire Nonjudging Subscale(6 months post intervention)
- State Mindfulness Bodily Sensations(3 weeks (i.e., immediately post-intervention))
- Five Facet Mindfulness Questionnaire Awareness Subscale(6 months post intervention)
- State Mindfulness Present Focus(3 weeks (i.e., immediately post-intervention))
- Five Facet Mindfulness Questionnaire Observing Subscale(baseline)
- Five Facet Mindfulness Questionnaire Observing Subscale(3 weeks (i.e., immediately post-intervention))
- Five Facet Mindfulness Questionnaire Observing Subscale(6 weeks post intervention)
- Five Facet Mindfulness Questionnaire Observing Subscale(12 weeks post intervention)
- Five Facet Mindfulness Questionnaire Describing Subscale(baseline)
- Five Facet Mindfulness Questionnaire Describing Subscale(3 weeks (i.e., immediately post-intervention))
- Five Facet Mindfulness Questionnaire Describing Subscale(6 weeks post intervention)
- Five Facet Mindfulness Questionnaire Describing Subscale(12 weeks post intervention)
- Five Facet Mindfulness Questionnaire Awareness Subscale(baseline)
- Five Facet Mindfulness Questionnaire Awareness Subscale(3 weeks (i.e., immediately post-intervention))
- Five Facet Mindfulness Questionnaire Awareness Subscale(6 weeks post intervention)
- Five Facet Mindfulness Questionnaire Awareness Subscale(12 weeks post intervention)
- Five Facet Mindfulness Questionnaire Nonjudging Subscale(baseline)
- Five Facet Mindfulness Questionnaire Nonjudging Subscale(3 weeks (i.e., immediately post-intervention))
- Five Facet Mindfulness Questionnaire Nonjudging Subscale(6 weeks post intervention)
- Five Facet Mindfulness Questionnaire Nonjudging Subscale(12 weeks post intervention)
- Five Facet Mindfulness Questionnaire Nonreactivity Subscale(baseline)
- Five Facet Mindfulness Questionnaire Nonreactivity Subscale(3 weeks (i.e., immediately post-intervention))
- Five Facet Mindfulness Questionnaire Nonreactivity Subscale(6 weeks post intervention))
- Five Facet Mindfulness Questionnaire Nonreactivity Subscale(12 weeks post intervention))
研究者
Lori Hilt
Associate Professor of Psychology
Lawrence University