Depression and/or Anxiety SymptomsNCT07892807
The Mindful Smartphone Use Study
A study testing Mindwire in people with Depression and/or Anxiety Symptoms and Problematic Phone Use Behavior, run by Brown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Depression and/or Anxiety Symptoms, Problematic Phone Use Behavior
- What is being tested?
- Mindwire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2026to 28 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brown University
Providence, Rhode Island, 02903
Shufang Sun, 4018635735, shufang_sun@brown.edu
Shufang Sun
About this study
Official title: Thriving in a Digital World: A Mindfulness-Based Pilot to Support Sleep and Mental Health in Teens
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
- Being tested
- Mindwire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindwireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindwire | Experimental | Not described Receives: Behavioral: Mindwire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (day 18)
Secondary outcomes (4)
Anxiety Symptoms as Measured by General Anxiety Disorder-7 (GAD-7)
The validated General Anxiety Disorder-7 (GAD-7) scale will be used to measure participants' anxiety symptoms. Participants rate 7 statements on a four-point Likert scale. Total scores for GAD-7 range from 0 to 21, with higher scores indicating more severe levels of anxiety symptoms.
Measured: Baseline, Post-intervention (day 18), and 2-month Follow-up
Depression Symptoms as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
The validated Center for Epidemiologic Studies Depression Scale (CES-D) scale will be used to measure participants' depression symptoms. Participants rate 20 statements on a four-point Likert scale. Total scores for CES-D range from 0 to 60, with higher scores indicating more severe levels of depression symptoms.
Measured: Baseline, Post-intervention (day 18), and 2-month Follow-up
Problematic Smartphone Use as Measured by Smartphone Addiction Scale - Short Version (SAS-SV)
The validated Smartphone Addiction Scale - Short Version (SAS-SV) scale will be used to measure participants' problematic phone use behavior. Participants rate 10 statements on a six-point Likert scale. Total scores for CES-D range from 10 to 60, with higher scores indicating a greater degree of problematic smartphone use.
Measured: Baseline, Post-intervention (day 18), and 2-month Follow-up
Sleep Quality as Measured by Adolescent Sleep Quality Scale (ASQS)
The validated Adolescent Sleep Quality Scale (ASQS) scale will be used to measure participants' sleep quality. Participants rate 8 statements on a four-point Likert scale. Total scores for CES-D range from 8 to 32, with higher scores indicating a worse sleep quality.
Measured: Baseline, Post-intervention (day 18), and 2-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start16 Oct 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression and/or Anxiety SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm feasibility trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Shufang Sun, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892807
- Sponsor's protocol ID
- STUDY00000943
- Other IDs
- P20GM139743
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following data collection, cleaning, and analysis, we plan to publish deidentified quantitative data at an open science data repository (e.g., Open Science Framework). De-identified qualitative data will be available upon request to the study PI.