Pregnancy
Conditions
Keywords
social media addiction, social media, pregnancy, mental health
Brief summary
The goal of this clinical trial is to learn if restricting social media use with a hardware device can improve mental health and well-being during pregnancy. It will also learn about the feasibility and acceptability of this approach. The main questions it aims to answer are: * Does restricting social media use lower the amount of time participants spend on social media? * Does restricting social media use improve depression, anxiety, well-being, loneliness, sleep, and physical activity? Researchers will compare participants who use a device (Brick™) that restricts social media apps to participants receiving usual care to see if the device improves social media use and mental health outcomes. Participants will: * Complete surveys about mood, sleep, and social media use, and wear/carry a smartphone app that tracks activity and sleep * Use the Brick device to restrict social media apps for 2 weeks, or continue their usual phone use * Complete follow-up surveys at the end of the 4-week study
Interventions
DEVICEBrick device
A hardware-based device that restricts access to user-selected social media applications by requiring physical interaction with the device to unlock them. Participants in the intervention arm will use the device continuously to block access to selected social media apps during a 2-week intervention period, following a 2-week baseline monitoring period. The device is not an FDA-regulated medical device and functions as a consumer hardware tool. Participants may voluntarily reverse the intervention (unlock the device) at any point during the study.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥18 years 2. Pregnant, with a viable pregnancy at 20-24 weeks' gestation 3. English fluency 4. Daily use of a personal iOS smartphone (iOS 17 or later). 5. Average social media screen time of at least 30 minutes per day, verified at enrollment via the iOS Screen Time report.
Exclusion criteria
1\. Non-viable pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent reduction in social media screen time | 2-week intervention period | Daily social media screen time, defined as total minutes per day spent in social media applications as captured by the device-native iOS Screen Time report, averaged across each 14-day observation window. For each participant, percent reduction is calculated as: \[(mean baseline daily minutes - mean post-intervention daily minutes) / mean baseline daily minutes\] × 100 where the baseline value is the mean of daily social media minutes over the 14 days preceding randomization and the follow-up value is the mean over the 14-day window at the end of the intervention period. Mean percent reduction will be compared between the intervention (Brick device) group and the usual care group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | Through completion of enrollment (approximately 9 months) | Number of participants enrolled and randomized, expressed as a proportion of those screened and confirmed eligible, and as the mean number enrolled per month over the recruitment period. |
| Retention rate | 2-week intervention period | Proportion of randomized participants who complete the end-of-intervention assessment with evaluable primary outcome data (iOS Screen Time report for the final 14-day window) |
| Adherence to Brick device use | 2-week intervention period | Among participants randomized to the intervention, the proportion of the number of minutes during which the Brick device was in use divided by the number of minutes during the active intervention period; reported as the group mean and as the proportion of participants achieving ≥90% adherent days. |
| Change in EPDS Score at 4 weeks | Enrollment to study completion (4 weeks) | Change in depressive symptoms from enrollment to study completion, measured using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item self-report questionnaire; each item is scored 0 to 3 and summed for a total score ranging from 0 to 30. Higher scores indicate more severe depressive symptoms (a worse outcome). Change is calculated as the study-completion score minus the baseline score, yielding a possible range of -30 to +30, where negative values indicate improvement. |
| Change in GAD-7 score at 4 weeks | Enrollment to study completion (4 weeks) | Change in anxiety symptoms from baseline to study completion, measured using the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a 7-item self-report questionnaire; each item is scored 0 to 3 and summed for a total score ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms (a worse outcome). Change is calculated as the study-completion score minus the baseline score, yielding a possible range of -21 to +21, where negative values indicate improvement. |
| Change in WHO-5 Score at 4 weeks | Enrollment to study completion (4 weeks) | Change in well-being from baseline to study completion, measured using the World Health Organization-Five Well-Being Index (WHO-5). The WHO-5 is a 5-item self-report questionnaire; each item is scored 0 to 5 and summed for a raw score of 0 to 25, which is multiplied by 4 to yield a final score ranging from 0 to 100. Higher scores indicate greater well-being (a better outcome). Change is calculated as the study-completion score minus the baseline score, yielding a possible range of -100 to +100, where positive values indicate improvement. |
| Change in UCLA-LS-3 score at 4 weeks | Enrollment to study completion (4 weeks) | Change in loneliness from baseline to study completion, measured using the Three-Item UCLA Loneliness Scale (UCLA-LS-3). The UCLA-LS-3 is a 3-item self-report questionnaire; each item is scored 1 to 3 and summed for a total score ranging from 3 to 9. Higher scores indicate greater loneliness (a worse outcome). Change is calculated as the study-completion score minus the baseline score, yielding a possible range of -6 to +6, where negative values indicate improvement. |
| Change in B-PSQI Score at 4 weeks | Enrollment to study completion (4 weeks) | Change in sleep quality from baseline to study completion, measured using the Brief Version of the Pittsburgh Sleep Quality Index (B-PSQI). The B-PSQI is a 6-item self-report questionnaire yielding five scored components (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, and frequency of night awakenings), each scored 0 to 3 and summed for a global score ranging from 0 to 15. Higher scores indicate poorer sleep quality (a worse outcome). Change is calculated as the study-completion score minus the baseline score, yielding a possible range of -15 to +15, where negative values indicate improvement. |
Countries
United States
Contacts
CONTACTLydia Shook, MD
Outcome results
None listed