Assessment-Based Study of Anxiety during the Perinatal Period

Recruiting

18 years or above

All

Phase N/A

34 participants needed

1 Location

Brief description of study

The purpose of this research study is to better understand anxiety fluctuations during the perinatal period using technology-based daily assessment of mood, anxiety, sleep, and activity levels. This study uses a daily mood diary to monitor anxiety and wearable technology to track sleep and physical activity. All tasks during the 28-day assessment period will be completed remotely. Participants will make two study visits to the site, once at the beginning of the study for the baseline interview and once at the end of the assessment period for the exit interview. Participants can earn up to $232 for completing all the study tasks. Study participation will be complete after 4 weeks.

Detailed description of study

This study is being conducted to test the feasibility and acceptability of anxiety, sleep, and activity ratings via app-based assessment to better understand how anxiety develops and is maintained in both pregnant and postpartum birthing people. The findings of this study will highlight important triggers that drive perinatal anxiety and optimal time for intervention. There is a critical need to develop modern solutions to screen, monitor, identify, and treat patients at-risk for anxiety in the perinatal period.

After a brief (10-15 minute) phone screen with a member of the study team, potential participants will be invited to the Center for the Treatment and Study of Anxiety (CTSA) to complete the baseline assessment. The baseline assessment will be conducted in-person to confirm eligibility, collect consent, complete self-report measures, and provide a walk-through demonstration of the technology-based assessment. Following this study visit, the 28-day assessment period will begin. Participants will remotely complete daily questionnaires through Metricwire (a HIPPA-compliant app that participants will download on their phones). Participants will receive 4 text message prompts a day to complete questionnaires about their current mood, anxiety, sleep, infant concerns, and suicidal urges. In addition, participants will be provided with a Fitbit – which will be used to track sleep and activity levels for the duration of the study. At the end of the study period, participants will be asked to make their second – and final – visit to CTSA. During this study visit, participants will be asked to return the wearable device, complete self-report measures, and complete an exit interview.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Anxiety
Age: 18 years or above
Gender: All

Adult participants aged 18 or older that
Are currently at least 14 weeks pregnant up until 9 months postpartum
And who have either elevated anxiety scores (GAD-7 >9) or a current diagnosis of an anxiety disorder

Updated on 17 Jun 2025. Study ID: 24-0260

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