Pregnancy RelatedNCT05285956
Feasibility of Calm to Reduce Stress and Improve Sleep During Pregnancy
A study testing Calm app in people with Pregnancy Related, run by Calm.com, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Calm app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women 14-16 or 28-30 weeks gestation
- Resident of United States
- Access to regular WiFI
- Access to a smartphone regularly
- Willing to download an app onto their smartphone
- Score of >13 on Perceived Stress Scale (PSS-10)] 31 and sleep quality [score of >5 on Pittsburgh Sleep Quality Index (PSQI)]
- Have not practiced meditation more than 60 minutes a month in the past six months
- Willing to be randomized to one of two groups.
Who cannot join
- <18 years of age
- Unable to consent
- First trimester (less than 14 weeks)
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Calm app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm appBehavioural
Calm is a popular, subscription-based, meditation app accessible across web-based and smartphone platforms (iOS and Android) with over 100 million downloads and four million subscribers. The app offers a range of content rooted in mindfulness principles to help users incorporate mindfulness into their lives and generally promote wellbeing (e.g., a large library of guided meditations including the 10-minute Daily Calm, Sleep Stories, educational courses, mindful movement, music, and nature scenes and sounds). Calm also teaches users the basics of mindfulness, includes components to remind users to meditate, track user activity, and allow users to share their status with others. The feasibility of the app and its efficacy for improving mental health outcomes (i.e., stress, anxiety, and depressive symptoms), mindfulness, and sleep have been previously tested in various populations providing evidence that using Calm may improve wellbeing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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) Receives: Behavioral: Calm app |
| Control | No intervention | Participants (n=90) will be asked to continue with usual care and complete survey measures at each time point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress (Perceived Stress Scale)
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.
Measured: Baseline, 4 weeks, 8 weeks
Change in Sleep Quality (Pittsburgh Sleep Quality Index)
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.
Measured: Baseline, 4 weeks, 8 weeks
Change in Depressive Symptoms (Edinburgh Postnatal Depression Scale)
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.
Measured: Baseline, 4 weeks, 8 weeks
Change in Anxiety (Pregnancy Related Anxiety Questionnaire)
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.
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (3)
Self-Reported Baby's Gestational Age at Birth
Gestational age
Measured: 2 weeks post due date
Self-Reported Baby's Birth Weight
Measured: 2 weeks post due date
Self-reported Childbirth Experience
Childbirth Experience Questionnaire
Measured: 2 weeks post due date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Mar 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Why it stopped: Personnel Change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calm.com, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jen Huberty, PhD, Study director, Calm.com, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285956
- Sponsor's protocol ID
- Calm2021-102
- Status last verified
- Aug 2022
- First submitted
- 23 Feb 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huberty J, Puzia ME, Green J, Vlisides-Henry RD, Larkey L, Irwin MR, Vranceanu AM. A mindfulness meditation mobile app improves depression and anxiety in adults with sleep disturbance: Analysis from a randomized controlled trial. Gen Hosp Psychiatry. 2021 Nov-Dec;73:30-37. doi: 10.1016/j.genhosppsych.2021.09.004. Epub 2021 Sep 11.
PubMed 34537477Huberty JL, Green J, Puzia ME, Larkey L, Laird B, Vranceanu AM, Vlisides-Henry R, Irwin MR. Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial. PLoS One. 2021 Jan 7;16(1):e0244717. doi: 10.1371/journal.pone.0244717. eCollection 2021.
PubMed 33411779Huberty J, Puzia ME, Larkey L, Irwin MR, Vranceanu AM. Use of the Consumer-Based Meditation App Calm for Sleep Disturbances: Cross-Sectional Survey Study. JMIR Form Res. 2020 Nov 13;4(11):e19508. doi: 10.2196/19508.
PubMed 33185552Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273.
PubMed 31237569Kwok OM, Underhill AT, Berry JW, Luo W, Elliott TR, Yoon M. Analyzing Longitudinal Data with Multilevel Models: An Example with Individuals Living with Lower Extremity Intra-articular Fractures. Rehabil Psychol. 2008 Aug;53(3):370-386. doi: 10.1037/a0012765.
PubMed 19649151Gravel J, Opatrny L, Shapiro S. The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say? Clin Trials. 2007;4(4):350-6. doi: 10.1177/1740774507081223.
PubMed 17848496
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Calm to Reduce Stress and Improve Sleep During Pregnancy
- ClinicalTrials.gov ID
- NCT05285956
- Acronym / sponsor ID
- Calm2021-102
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Personnel Change
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Calm.com, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Calm appParticipants (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) |
| Control | No intervention | –Participants (n=90) will be asked to continue with usual care and complete survey measures at each time point. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pregnant women 14-16 or 28-30 weeks gestation
- Resident of United States
- Access to regular WiFI
- Access to a smartphone regularly
- Willing to download an app onto their smartphone
Key exclusion criteria (3 listed)
- <18 years of age
- Unable to consent
- First trimester (less than 14 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calm appCalm is a popular, subscription-based, meditation app accessible across web-based and smartphone platforms (iOS and Android) with over 100 million downloads and four million subscribers. The app offers a range of content rooted in mindfulness principles to help users incorporate mindfulness into their lives and generally promote wellbeing (e.g., a large library of guided meditations including the 10-minute Daily Calm, Sleep Stories, educational courses, mindful movement, music, and nature scenes and sounds). Calm also teaches users the basics of mindfulness, includes components to remind users to meditate, track user activity, and allow users to share their status with others. The feasibility of the app and its efficacy for improving mental health outcomes (i.e., stress, anxiety, and depressive symptoms), mindfulness, and sleep have been previously tested in various populations providing evidence that using Calm may improve wellbeing. | Behavioural | Intervention |
Primary outcome
Change in Stress (Perceived Stress Scale)
Time frame: 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 Sleep Quality (Pittsburgh Sleep Quality Index)
Time frame: 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)
Time frame: 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.
Change in Anxiety (Pregnancy Related Anxiety Questionnaire)
Time frame: 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.
3 secondary outcomes
Self-Reported Baby's Gestational Age at Birth
Time frame: 2 weeks post due date
Self-Reported Baby's Birth Weight
Time frame: 2 weeks post due date
Self-reported Childbirth Experience
Time frame: 2 weeks post due date
Results and safety
The study was stopped early (reason given: Personnel Change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Background: PubMed 34537477Huberty J, Puzia ME, Green J, Vlisides-Henry RD, Larkey L, Irwin MR, Vranceanu AM. A mindfulness meditation mobile app improves depression and anxiety in adults with sleep disturbance: Analysis from a randomized controlled trial. Gen Hosp Psychiatry. 2021 Nov-Dec;73:30-37. doi: 10.1016/j.genhosppsych.2021.09.004. Epub 2021 Sep 11.
- Background: PubMed 33411779Huberty JL, Green J, Puzia ME, Larkey L, Laird B, Vranceanu AM, Vlisides-Henry R, Irwin MR. Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial. PLoS One. 2021 Jan 7;16(1):e0244717. doi: 10.1371/journal.pone.0244717. eCollection 2021.
- Background: PubMed 33185552Huberty J, Puzia ME, Larkey L, Irwin MR, Vranceanu AM. Use of the Consumer-Based Meditation App Calm for Sleep Disturbances: Cross-Sectional Survey Study. JMIR Form Res. 2020 Nov 13;4(11):e19508. doi: 10.2196/19508.
- Background: PubMed 31237569Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273.
- Background: PubMed 19649151Kwok OM, Underhill AT, Berry JW, Luo W, Elliott TR, Yoon M. Analyzing Longitudinal Data with Multilevel Models: An Example with Individuals Living with Lower Extremity Intra-articular Fractures. Rehabil Psychol. 2008 Aug;53(3):370-386. doi: 10.1037/a0012765.
- Background: PubMed 17848496Gravel J, Opatrny L, Shapiro S. The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say? Clin Trials. 2007;4(4):350-6. doi: 10.1177/1740774507081223.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jen Huberty, PhD study director
Calm.com, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calm app in people with Pregnancy Related, run by Calm.com, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Personnel Change). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stress (Perceived Stress Scale) (time frame: Baseline, 4 weeks, 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05285956, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.