Adolescent Mindfulness Mobile App Study (RCT)

Depression Clinical Trial

— AMMASRCT  

Official title:

Mindfulness-based Mobile Application to Reduce Rumination in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03900416
• Other study ID #: 7_25_18_Hilt
• Status: Completed
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: February 3, 2021

Study information

• Verified date: October 2021
• Source: Lawrence University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: February 3, 2021
• Est. primary completion date: February 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Rumination
• Self-Injurious Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	Lawrence University	Appleton	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Lawrence University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Response Styles Questionnaire	trait rumination (range = 0-39 with higher scores indicating more rumination)	baseline
Primary	Children's Response Styles Questionnaire	trait rumination (range = 0-39 with higher scores indicating more rumination)	3 weeks (i.e., immediately post-intervention)
Primary	Children's Response Styles Questionnaire	trait rumination (range = 0-39 with higher scores indicating more rumination)	6 weeks post intervention
Primary	Children's Response Styles Questionnaire	trait rumination (range = 0-39 with higher scores indicating more rumination)	12 weeks post intervention
Primary	Children's Response Styles Questionnaire	trait rumination (range = 0-39 with higher scores indicating more rumination)	6 months post intervention
Primary	Children's Depression Inventory	self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)	baseline
Primary	Children's Depression Inventory	self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)	3 weeks (immediately post-intervention)
Primary	Children's Depression Inventory	self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)	6 weeks post intervention
Primary	Children's Depression Inventory	self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)	12 weeks post intervention
Primary	Children's Depression Inventory	self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)	6 months post intervention
Primary	Multidimensional Anxiety Scale for Children	self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)	baseline
Primary	Multidimensional Anxiety Scale for Children	self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)	3 weeks (i.e., immediately post-intervention)
Primary	Multidimensional Anxiety Scale for Children	self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)	6 weeks post intervention
Primary	Multidimensional Anxiety Scale for Children	self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)	12 weeks post intervention
Primary	Multidimensional Anxiety Scale for Children	self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)	6 months post intervention
Primary	Self-injurious Thoughts and Behaviors Questionnaire	percent of participants engaged in self-injury over the past year	baseline
Primary	Self-injurious Thoughts and Behaviors Questionnaire	percent of participants that engaged in self-injury over the past 3 weeks	3 weeks (i.e., immediately post-intervention)
Primary	Self-injurious Thoughts and Behaviors Questionnaire	percent of participants that engaged in self-injury over the past 6 weeks	6 weeks post intervention
Primary	Self-injurious Thoughts and Behaviors Questionnaire	percent of time engaged in self-injury over the past 6 weeks	12 weeks post intervention
Primary	Self-injurious Thoughts and Behaviors Questionnaire	percent of time engaged in self-injury over the past 3 months	6 months post intervention
Primary	Pediatric Symptom Checklist Internalizing Scale	parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)	baseline
Primary	Pediatric Symptom Checklist Internalizing Scale	parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)	3 weeks (i.e., immediately post-intervention)
Primary	Pediatric Symptom Checklist Internalizing Scale	parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)	6 weeks post intervention
Primary	Pediatric Symptom Checklist Internalizing Scale	parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)	12 weeks post intervention
Primary	Pediatric Symptom Checklist Internalizing Scale	parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)	6 months post intervention
Primary	State Rumination	average state rumination during intervention period rated on a visual analog scale (range = 0-100 with higher scores indicating more rumination)	3 weeks (i.e., immediately post-intervention)
Primary	State Mood	average sadness and anxiety during intervention period rated on visual analog scales (range = 0-100 with higher scores indicating more rumination)	3 weeks (i.e., immediately post-intervention)
Primary	Daily App Use	Daily app use was determined by how many complete app uses were logged during the three-week intervention period.	3 weeks (i.e., immediately post-intervention)
Primary	Continued Use	Number of times app was used after the 3 week intervention period	6 months post intervention
Primary	Ease of Use	how easy app was to use (range = 1-7 with higher being easier to use)	3 weeks (i.e., immediately post-intervention)
Secondary	Five Facet Mindfulness Questionnaire Observing Subscale	trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)	baseline
Secondary	Five Facet Mindfulness Questionnaire Observing Subscale	trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)	3 weeks (i.e., immediately post-intervention)
Secondary	Five Facet Mindfulness Questionnaire Observing Subscale	trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)	6 weeks post intervention
Secondary	Five Facet Mindfulness Questionnaire Observing Subscale	trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)	12 weeks post intervention
Secondary	Five Facet Mindfulness Questionnaire Observing Subscale	trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)	6 months post intervention
Secondary	Five Facet Mindfulness Questionnaire Describing Subscale	trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)	baseline
Secondary	Five Facet Mindfulness Questionnaire Describing Subscale	trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)	3 weeks (i.e., immediately post-intervention)
Secondary	Five Facet Mindfulness Questionnaire Describing Subscale	trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)	6 weeks post intervention
Secondary	Five Facet Mindfulness Questionnaire Describing Subscale	trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)	12 weeks post intervention
Secondary	Five Facet Mindfulness Questionnaire Describing Subscale	trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)	6 months post intervention
Secondary	Five Facet Mindfulness Questionnaire Awareness Subscale	trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)	baseline
Secondary	Five Facet Mindfulness Questionnaire Awareness Subscale	trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)	3 weeks (i.e., immediately post-intervention)
Secondary	Five Facet Mindfulness Questionnaire Awareness Subscale	trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)	6 weeks post intervention
Secondary	Five Facet Mindfulness Questionnaire Awareness Subscale	trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)	12 weeks post intervention
Secondary	Five Facet Mindfulness Questionnaire Awareness Subscale	trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)	6 months post intervention
Secondary	Five Facet Mindfulness Questionnaire Nonjudging Subscale	trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)	baseline
Secondary	Five Facet Mindfulness Questionnaire Nonjudging Subscale	trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)	3 weeks (i.e., immediately post-intervention)
Secondary	Five Facet Mindfulness Questionnaire Nonjudging Subscale	trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)	6 weeks post intervention
Secondary	Five Facet Mindfulness Questionnaire Nonjudging Subscale	trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)	12 weeks post intervention
Secondary	Five Facet Mindfulness Questionnaire Nonjudging Subscale	trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)	6 months post intervention
Secondary	Five Facet Mindfulness Questionnaire Nonreactivity Subscale	trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)	baseline
Secondary	Five Facet Mindfulness Questionnaire Nonreactivity Subscale	trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)	3 weeks (i.e., immediately post-intervention)
Secondary	Five Facet Mindfulness Questionnaire Nonreactivity Subscale	trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)	6 weeks post intervention)
Secondary	Five Facet Mindfulness Questionnaire Nonreactivity Subscale	trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)	12 weeks post intervention)
Secondary	Five Facet Mindfulness Questionnaire Nonreactivity Subscale	trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)	6 months post intervention)
Secondary	State Mindfulness Bodily Sensations	average focus on bodily sensations during intervention period rated on visual analog scale (range = 0-100 with higher scores indicating more mindfulness)	3 weeks (i.e., immediately post-intervention)
Secondary	State Mindfulness Present Focus	average % focus on present moment (as opposed to past or future focus) during intervention period indicating more mindfulness	3 weeks (i.e., immediately post-intervention)