Adolescent Mindfulness Mobile App Study (RCT)

NCT ID: NCT03900416

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-17
• Study Completion Date: 2021-02-03

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.

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.

Conditions

Rumination; Depression; Anxiety; Self-Injurious Behavior

Keywords

Mindfulness; Mobile Intervention; Brief Intervention; Adolescence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mindfulness App

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

Group Type: EXPERIMENTAL

Mindfulness App

Intervention Type: 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.

Control condition

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lawrence University

OTHER

Sponsor Role: lead

Responsible Party

Lori Hilt

Associate Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lori M Hilt, PhD

Role: PRINCIPAL_INVESTIGATOR

Lawrence University

Locations

Lawrence University

Appleton, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36622879 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36279218 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

7_25_18_Hilt

Identifier Type: -

Identifier Source: org_study_id