An interventional study of Mindwire in Depression and/or Anxiety Symptoms and Problematic Phone Use Behavior, sponsored by Brown University. Recruiting at 1 site in United States. Open to participants aged 13 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Brown University · Not applicable, Interventional, and Other
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:
Brown University is the lead sponsor of 288 studies on the registry; 38 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.
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Inclusion Criteria:
Behavioral: Mindwire
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-intervention (day 18)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Post-intervention (day 18), and 2-month Follow-up
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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