Feasibility of Calm to Reduce Stress and Improve Sleep During Pregnancy
- Conditions
- Pregnancy Related
- Interventions
- Behavioral: Calm app
- Registration Number
- NCT05285956
- Lead Sponsor
- Calm.com, Inc.
- Brief 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
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 4
Not provided
- <18 years of age
- Unable to consent
- First trimester (less than 14 weeks)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Calm app Participants (n=90) will be provided free access to and asked to register for the consumer-based mobile meditation app, Calm, on their phone. Participants will then receive an email containing one year of free access to Calm. Participants will be asked to use Calm at least 10 minutes per day for 8 weeks. Women will be asked to use 10 sessions of specific pregnancy content for the first four weeks and then will have autonomy to use the app how they prefer for the remainder of the study period (with continued encouragement to use the pregnancy meditations)
- Primary Outcome Measures
Name Time Method Change in Stress (Perceived Stress Scale) Baseline, 4 weeks, 8 weeks The Perceived Stress Scale (PSS) is a 10-item scale. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Change in Anxiety (Pregnancy Related Anxiety Questionnaire) Baseline, 4 weeks, 8 weeks The Pregnancy Related Anxiety Questionnaire, Revised version 2 (PRAQ-R2 ) contains 10 questions, grouped into three subscales: fear of giving birth (FoGB; items 1, 2, and 6), worries of bearing a physically or mentally handicapped child (WaHC; items 4, 9, 10, and 11); and concern about own appearance (CoA; items 3, 5, and 7). An additional item is ("I am anxious about the delivery"). The total score (ranging from 10 to 50 points) and the sum of item scores that make up the three subscales are calculated. Higher scores are assumed to indicate increased pregnancy related anxiety intensity. No clinical cutoff point is currently defined for this tool.
Change in Sleep Quality (Pittsburgh Sleep Quality Index) Baseline, 4 weeks, 8 weeks The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions. The items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to form one "global" score, with a range of 0-21, "0" indicating no difficulty, and "21" indicating severe difficulties in all areas.
Change in Depressive Symptoms (Edinburgh Postnatal Depression Scale) Baseline, 4 weeks, 8 weeks The 10-question Edinburgh Postnatal Depression Scale (EPDS) is a valuable, efficient, and proven effective screening tool for identifying patients at risk for "perinatal" depression. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity. The scale indicates how the mother has felt during the previous week.
- Secondary Outcome Measures
Name Time Method Self-reported Childbirth Experience 2 weeks post due date Childbirth Experience Questionnaire
Self-Reported Baby's Birth Weight 2 weeks post due date Self-Reported Baby's Gestational Age at Birth 2 weeks post due date Gestational age
Trial Locations
- Locations (1)
Calm, Inc.
🇺🇸San Francisco, California, United States