The Mindful Smartphone Use Study

NCT07892807 | Recruiting

• 2 other identifiers: STUDY00000943P20GM139743
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to understand the feasibility and acceptability on a mindfulness-based intervention to address co-existing smartphone addiction and psychological distress among adolescents ages 13-19 self-reporting elevated levels of depression and/or anxiety symptoms and problematic digital phone use. The main questions it aims to answer are: (1) is Mindwire, a mindfulness-based intervention, feasible and acceptable in addressing co-existing smartphone addiction and psychological distress among adolescents; and (b) what are the mechanistic pathways, particularly the role of circadian rhythm, sleep quality, and emotion regulation, in phone use and psychological distress. Participants will be in this research study for 3 months. After screening and onboarding, they will be asked to:

• participate in 18 days of the Mindwire program
• answer a 45-60 minute online survey immediately before, immediately after, and approximately six weeks after the Mindwire program
• participate in a 60-90 minute interview asking about their experience going through the program

Conditions

Depression and/or Anxiety Symptoms; Problematic Phone Use Behavior

Outcome Measures

Primary Outcomes (5)

• Study Recruitment Feasibility as Measured by Participant Recruitment Rates

  Participant recruitment will be assessed as the percentage (%) of eligible individuals who enroll in the study out of the total number of individuals screened for eligibility. This data will be collected using tracking sheets maintained by the research team, which document the number of individuals assessed for eligibility and those who subsequently consent and enroll. This recruitment rate will be used to evaluate the feasibility of the study/intervention.

  During recruitment period of study, up to 3 months

• Study Retention Feasibility as Measured by Participant Retention Rates

  Participant retention rates will be assessed as the percentage (%) of enrolled participants who complete study assessments at each time point (baseline, post-intervention, and 2-month follow-up). This will be data will be collected using assessment completion records maintained by the research team, which document participant completion of assessments. This retention rate will be used to evaluate the feasibility of the intervention.

  Baseline, Post-intervention (day 18), and 2-month Follow-up

• Intervention Engagement Feasibility as Measured by Participant Engagement with Intervention

  Participant engagement with the intervention (i.e., adherence) will be assessed as the percentage (%) of prescribed intervention activities completed by participants over the study period. This data will be collected using application logs and session attendance records maintained by the research team. This engagement data will be used to evaluate the feasibility of the intervention.

  During intervention period (18 days)

• Intervention Acceptability as Measured by Client Satisfaction Questionnaire (CSQ-8)

  The validated 8-item Client Satisfaction Questionnaire (CSQ-8) will be used to measure the acceptability of the GEM intervention. Participants rate each item on a four-point Likert scale. Total scores for the CSQ-8 range from 8 to 32, with higher scores indicating higher satisfaction with the intervention.

  Post-intervention (day 18)

• Intervention Acceptability as Measured by Session Evaluation Form

  Session evaluation form (a self-developed measure) will be used to measure the acceptability of the GEM intervention. The instrument consists of 10 questions, rated on a four-point Likert scale. Total scores range from 10 to 40, with higher scores indicating higher satisfaction with the intervention.

  Post-intervention (day 18)

Secondary Outcomes (4)

• Anxiety Symptoms as Measured by General Anxiety Disorder-7 (GAD-7)

  Baseline, Post-intervention (day 18), and 2-month Follow-up

• Depression Symptoms as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)

  Baseline, Post-intervention (day 18), and 2-month Follow-up

• Problematic Smartphone Use as Measured by Smartphone Addiction Scale - Short Version (SAS-SV)

  Baseline, Post-intervention (day 18), and 2-month Follow-up

• Sleep Quality as Measured by Adolescent Sleep Quality Scale (ASQS)

  Baseline, Post-intervention (day 18), and 2-month Follow-up

Study Arms (1)

Mindwire

EXPERIMENTAL

Behavioral: Mindwire

Interventions

Mindwire BEHAVIORAL

Mindwire is an 18-day mindfulness-based, app-delivered program to support adolescents develop better coping skills and be more intentional about their phone use. In the first 4 days, participants will be listening to 5-6 short audio recordings, accompanied by text transcripts as a foundational introduction (\~4-5 minutes each), followed by booster audio recordings on Days 8 and 12. The modules will cover a variety of topics including effects of light and stress on sleep, common sleep myths, mindful wind-down routines, and stress management. Then from Days 5 to 18 (i.e., 2 weeks), participants will be asked to complete up to 3 brief surveys per day, focused on their mood and emotions. For some of these surveys, they may also be asked to complete a brief mindfulness practice. The surveys and mindfulness practices will come out to a total of approximately 30 minutes per day.

Mindwire

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Own a smartphone (iOS or Android)
• Can read, write, and speak in English due to the measurement and intervention delivered in English;
• Resides in the United States
• Experience mild to moderate levels of depression and/or anxiety symptoms, indicated by PHQ-8 (total score 5-14) and GAD-7 (total score higher than 5)
• Self-report problematic digital device use, defined as following:
• Self-report mobile phone use daily with \>4 hours on average on weekdays
• Self-report smartphone use in bed after 10pm ≥ 3 nights/week
• Say 'Yes' to 2 out of 5 statements regarding problematic phone use: (1) I have found myself engaged on my phone for longer periods of time than initially intended; (2) I have used my phone when I knew I intended to be sleeping or doing work/schoolwork; (3) When I do not use my phone for some time, I feel anxious, moody, or irritable; (4) I have found myself using my phone instead of spending time with people who are important to me and want to spend time with me; and (5) I have used my mobile phone to make myself feel better when I was feeling down

Sponsors & Collaborators

• Brown University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02903, United States

RECRUITING

Study Officials

• Shufang Sun, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Global Mental Health and Flourishing Lab

CONTACT

401-863-1899; flourishing@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm feasibility trial

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start: October 16, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)