Adolescent Mindfulness Mobile App Study (RCT)

NCT03900416 | Completed Results

• 1 other identifier: 7_25_18_Hilt
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Rumination; Depression; Anxiety; Self-Injurious Behavior

Keywords

Mindfulness; Mobile Intervention; Brief Intervention; Adolescence

Outcome Measures

Primary Outcomes (30)

• Children's Response Styles Questionnaire

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

  baseline

• Children's Response Styles Questionnaire

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

  3 weeks (i.e., immediately post-intervention)

• Children's Response Styles Questionnaire

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

  6 weeks post intervention

• Children's Response Styles Questionnaire

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

  12 weeks post intervention

• Children's Response Styles Questionnaire

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

  6 months post intervention

• Children's Depression Inventory

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

  baseline

• Children's Depression Inventory

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

  3 weeks (immediately post-intervention)

• Children's Depression Inventory

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

  6 weeks post intervention

• Children's Depression Inventory

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

  12 weeks post intervention

• Children's Depression Inventory

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

  6 months post intervention

• Multidimensional Anxiety Scale for Children

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

  baseline

• 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)

• Multidimensional Anxiety Scale for Children

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

  6 weeks post intervention

• Multidimensional Anxiety Scale for Children

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

  12 weeks post intervention

• Multidimensional Anxiety Scale for Children

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

  6 months post intervention

• Self-injurious Thoughts and Behaviors Questionnaire

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

  baseline

• 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)

• Self-injurious Thoughts and Behaviors Questionnaire

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

  6 weeks post intervention

• Self-injurious Thoughts and Behaviors Questionnaire

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

  12 weeks post intervention

• Self-injurious Thoughts and Behaviors Questionnaire

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

  6 months post intervention

• Pediatric Symptom Checklist Internalizing Scale

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

  baseline

• 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)

• Pediatric Symptom Checklist Internalizing Scale

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

  6 weeks post intervention

• Pediatric Symptom Checklist Internalizing Scale

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

  12 weeks post intervention

• Pediatric Symptom Checklist Internalizing Scale

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

  6 months post intervention

• 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)

• 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)

• 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)

• Continued Use

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

  6 months post intervention

• 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 Outcomes (27)

• 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 Observing Subscale

  6 months post intervention

Study Arms (2)

Mindfulness App

EXPERIMENTAL

Guided mindfulness exercises will be delivered via mobile app for three weeks.

Behavioral: Mindfulness App

Control condition

NO INTERVENTION

Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.

Interventions

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.

Mindfulness App

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lawrence University: lead

Study Sites (1)

Lawrence University

Appleton, Wisconsin, 54911, United States

Location

Related Publications (2)

• Hilt LM, Swords CM, Webb CA. Randomized Controlled Trial of a Mindfulness Mobile Application for Ruminative Adolescents. J Clin Child Adolesc Psychol. 2025 Jan-Feb;54(1):99-112. doi: 10.1080/15374416.2022.2158840. Epub 2023 Jan 9.

  PMID: 36622879 DERIVED

• Webb CA, Swords CM, Lawrence HR, Hilt LM. Which adolescents are well-suited to app-based mindfulness training? A randomized clinical trial and data-driven approach for personalized recommendations. J Consult Clin Psychol. 2022 Sep;90(9):655-669. doi: 10.1037/ccp0000763.

  PMID: 36279218 DERIVED

MeSH Terms

Conditions

Rumination Syndrome; Depression; Anxiety Disorders; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Lori Hilt
• Organization: Lawrence University

lori.m.hilt@lawrence.edu

920-832-7050

Study Officials

• Lori M Hilt, PhD

  Lawrence University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Model Details: 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).

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: April 3, 2019
• Study Start: June 17, 2019
• Primary Completion: February 3, 2021
• Study Completion: February 3, 2021
• Last Updated: November 8, 2021
• Results First Posted: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)