Feasibility of Calm to Reduce Stress and Improve Sleep During Pregnancy

Pregnancy Related Clinical Trial

Official title: Feasibility of Calm to Reduce Stress and Improve Sleep During Pregnancy

Status Terminated

Clinical Trial Summary

Purpose: Test the effects of using Calm for its impact on stress, anxiety, and sleep in pregnant women using the following aims:

Aim #1: Determine the feasibility of using Calm.

Aim #2: Determine the preliminary efficacy of using Calm on stress, anxiety, and sleep.

Exploratory Aim #3: Explore the preliminary efficacy of using Calm on self-reported birth outcomes

Clinical Trial Description

Rates of stress and poor sleep affect up to 70% of pregnant women with rates even higher in racial and ethnic minority (REM) women. Stress and poor sleep are often untreated or misdiagnosed, especially in lower income and REM populations, due to high health-related costs or lack of insurance and may underestimate the prevalence of stress and poor sleep. High stress and poor sleep increases risk of depression, anxiety, pregnancy complications, and poor birth outcomes. Research suggests that stress and poor sleep are strongly associated during pregnancy. In fact, poor sleep in pregnancy has been regarded as both an outcome of stress and a stressor in itself and improving sleep has been suggested as a strategy to protect maternal mental health. There is a need for interventions particularly among REM pregnant women to reduce stress and improve sleep.

Treatments for prenatal stress and poor sleep are inadequate in meeting the needs of pregnant women. Typical treatments are usually an aggregation of medication, interpersonal psychotherapy, and cognitive behavioral therapy. However, mental health stigma and concern with potential teratogenic effects from medication use may discourage women to seek help and many prefer non-pharmacological approaches. Mindfulness meditation (MM) is a nonpharmacological approach effective for reducing stress and improving sleep during pregnancy. MM can be described as the practice of self-regulation of attention and accepting the present moment. MM interventions may moderate the impact of poor sleep quality on stress and can have lasting effects with regular practice. Furthermore, MM is a recommended strategy for pregnant women to improve mental health. While there is evidence for the benefits of MM, many studies report high drop-out rates due to inconvenience, travel, or child care demands. Accessible, low cost, MM interventions to improve stress and sleep outcomes for pregnant women are warranted.

Delivery of MM using smartphone applications (apps) for the management of stress and sleep has dramatically increased in recent years. App-based MM can be delivered remotely, substantially increasing reach, accessibility, and scalability. Over 260 MM apps exist, but many consumer-based apps have low evidence for their efficacy among pregnant and REM users. Calm is a popular, consumer-based MM app that has over 100 million downloads, four million subscribers, and has demonstrated effects in stress and improved sleep in non-pregnant populations. In our preliminary survey data, pregnant subscribers of the Calm app most commonly used the app for sleep problems (29%; n=31) and reported the app was most helpful for improving sleep (32%; n=32) and stress (21%; n=21). Currently, the feasibility and potential impact of the Calm app to reduce stress and improve sleep in pregnant REM women is unknown. ;

Related Conditions & MeSH terms

• Pregnancy Related

• NCT number: NCT05285956
• Study type: Interventional
• Source: Calm.com, Inc.
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2022
• Completion date: August 1, 2022