Pregnant WomenNCT04264910
CALM Pregnancy: Feasibility of Calm for Pregnant Women
A study testing Calm App in people with Pregnant Women, run by Arizona State University at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility of using a consumer-based mindfulness app, Calm, to reduce stress during pregnancy. Women will be randomly assigned to an intervention group (i.e., Calm) or standard care group and asked to participate in at least 10 minutes of daily meditation for the duration… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- 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
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 30 Jun 2021
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women 12-16 weeks pregnant
- 18 years of age
- English speaking
- not currently on steroid therapy
- willing to download the Calm app to their smartphone,
- have not practiced meditation or mindful movement more than 60 minutes a month in the past six months
- willing to be randomized to one of two groups.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004
About this study
Official title: CALM Pregnancy: Feasibility of Mindfulness-based Prenatal Stress Reduction Using a Smart Phone Meditation Application
The purpose of this study is to determine the feasibility of using a consumer-based mindfulness app, Calm, to reduce stress during pregnancy. Women will be randomly assigned to an intervention group (i.e., Calm) or standard care group and asked to participate in at least 10 minutes of daily meditation for the duration of their pregnancy (i.e., 12-weeks' gestation up to date of birth).
Aim #1: Determine the feasibility (acceptability and demand) of using the Calm app at least 10-minutes per day for the duration of pregnancy (i.e., 12-weeks' gestation up to date of birth). Acceptability will be measured with an investigator-developed satisfaction survey.
Read more
Demand will be measured using time spent in meditation and meditations used (tracked by Calm).
For the intervention group, the benchmarks will be as follows:
- Acceptability (i.e., satisfaction) 70% (n=34) of participants will report a 75% satisfaction,
- Demand (i.e., time spent in meditation and meditations used,) 70% (n=34) of participants will adhere to ≥75% of prescribed meditation using Calm.
Aim #2: Determine the preliminary effects of using Calm at least 10-minutes per day for the duration of pregnancy (i.e., 12-16 weeks' gestation to date of birth) on stress. Stress will be measured using the Perceived Stress Scale (PSS) at baseline (i.e., 12-16-weeks' gestation) and every four weeks for the duration of the intervention using Ecological Momentary Assessment (i.e., text message). Stress will also be measured using cortisol serum at baseline (i.e., 12-16-weeks' gestation), and 32 weeks' gestation.
Exploratory Aim #3: The investigators will explore the preliminary effects of using Calm at least 10-minutes per day for the duration of pregnancy (i.e., 12-16 weeks' gestation to date of birth) on gestational age of birth, fetal weight, APGAR scores (i.e., health score), and neonatal complications with time spent in neonatal intensive unit (if applicable).
Read the detailed description
Enrollment: Interested participants at Valley Perinatal Clinics will be asked for their email and will be sent a link to a brief (5-10 minute) eligibility screener via RedCap (See Eligibility screener). Eligible participants will be asked to watch a brief intake video followed by a 3-question quiz and asked to sign an electronic informed consent prior to completing any further surveys. After informed consents have been completed, participants (N=97) will be identified. Participants will be asked to complete a baseline questionnaire (See Surveys and Questionnaires document) and complete a medical history form, which will ask participants to include a history of medications. They also will be asked to sign a medical release form for their obstetrician. Ineligible participants will be notified by email according to the script (See Email Scripts document).
Randomization: Participants will be randomized into either the intervention (Calm App) or standard prenatal care control and given further instructions to begin participating (See Welcome Email in Email Scripts document).
Inclusion criteria are: (1) women 12-16 weeks pregnant, (2) >18 years of age, (3) English speaking, (3) not currently on steroid therapy, (4) willing to download the Calm app to their smartphone, and (5) have not practiced meditation or mindful movement more than 60 minutes a month in the past six months (6) willing to be randomized to one of two groups.
Control: The control group will be asked to maintain normal activity and refrain from using Calm meditation app.
Intervention: Participants (n=49) will be provided free access to and asked to register for the consumer-based mobile meditation app on their phone. Participants (n=49) will then receive an email containing 28 weeks of free access to Calm. Participants (n=49) will be asked to use Calm at least 10 minutes per day and encouraged to use it as much as they would like during the intervention. This prescription mimics how a new, paying member would use the app (full exposure with autonomy).
Meditation Tracking: Intervention participants (n=49) usage will be continuously tracked throughout the intervention by Calm.
Assessments: Intervention group participants will receive self-report questionnaires (via RedCap) at baseline, and post intervention only after informed consent has been is obtained. Included within these questionnaires the investigators will measure demographics (baseline only) and stress (using the Perceived Stress Scale), mindfulness (using the Mindfulness Attention Awareness Scale), depression (using the Edinburgh Postnatal Depression Scale), anxiety (using the Pregnancy Related Anxiety Questionnaire), self-compassion (using the Self-Compassion Scale), emotional regulation (using the Difficulties in Emotional Regulations Scale), gratitude (using the Gratitude During Pregnancy Scale), and childbirth experience (using the Childbirth Experience Questionnaire). Every four weeks for the duration of the intervention, the investigators will measure stress and mindfulness using Ecological Momentary Assessment (i.e., text message). At baseline, mid-intervention (24-26 weeks' gestation), and baseline (32-34 weeks' gestations) depression, anxiety, self-compassion, emotional regulation, and gratitude will be measured. After the baby is born, depression, anxiety, self-compassion, emotional regulation, and childbirth experience will be measured.
Stress will also be measured using cortisol serum at baseline (i.e., 12-16-weeks' gestation) and 32 weeks. These tests will be performed at no additional cost to the participant. The blood draws will be completed at Valley Perinatal Clinic by a trained employee of Valley Perinatal Clinic. No more than one tube (10 mL) of blood will be taken for the cortisol serum test.
A weekly log (via RedCap) recording any changes in medications will be sent to participants. Any changes in medications, specifically ISSRs, will be accounted for in data analysis.
Acceptability is dually defined as participant satisfaction with content (i.e., Calm) and perceived appropriateness and usefulness of the behavioral components (i.e., reminders, self-monitoring) for self-management. Acceptability will be measured with an investigator-developed satisfaction survey, included within the post intervention questionnaire. Acceptability will be defined as 70% (n=34) of participants reporting a 75% satisfaction.
Demand will be measured by compliance to the >10 mins/day and sustained use during pregnancy. Demand (i.e., time spent in meditation and meditations used) will be defined as 70% (n=34) of participants adhering to ≥75% of prescribed meditation using Calm. Demand will be measured by Calm (internally) and shared with Arizona State University.
- Conditions
- Pregnant Women
- 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 subscription-based meditation app which provides guided meditations, sleep stories, soundscapes and calming music. Calm offers 7 Days of Calm for those new to meditation, the daily Calm, a meditation posted daily and a library of unique 10-12 minute meditations with topics related to acceptance, anxiety, self-compassion, and physical pain (to name a few).
| Study group | Role | What they receive |
|---|---|---|
| Calm Meditation | Experimental | Participants (n=49) will be provided free access to and asked to register for the consumer-based mobile meditation app on their phone. Participants (n=49) will then receive an email containing 28 weeks of free access to Calm. Participants (n=49) will be asked to use Calm at least 10 minutes per day and encouraged to use it as much as they would like during the intervention. This prescription mimics how a new, paying member would use the app (full exposure with autonomy). Receives: Behavioral: Calm App |
| Control | No intervention | The control group will be asked to maintain normal activity and refrain from using Calm meditation app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Acceptability
Acceptability will be measured with an investigator developed survey
Measured: Two weeks after delivery of baby
Feasibility: Demand (Time spent in meditation and meditations used)
Demand will be gathered using meditation app usage data and defined as at least 70% of intervention group will adhere to at 75% of prescribed meditation
Measured: At birth/delivery
Secondary outcomes (1)
Perceived Stress of Participant
Stress will be measured with PSS; scores may range from 0-40. Higher scores indicate higher stress levels.
Measured: baseline, 16, 20, 24, 28, 32, and 36 weeks' gestation, two weeks after delivery of baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Nov 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Valley Perinatal Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264910
- Sponsor's protocol ID
- STUDY00010467
- Status last verified
- Jul 2022
- First submitted
- 13 Jan 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CALM Pregnancy: Feasibility of Mindfulness-based Prenatal Stress Reduction Using a Smart Phone Meditation Application
- ClinicalTrials.gov ID
- NCT04264910
- Acronym / sponsor ID
- STUDY00010467
- Conditions
- Pregnant Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Valley Perinatal Services
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 11 Feb 2020 (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.
The purpose of this study is to determine the feasibility of using a consumer-based mindfulness app, Calm, to reduce stress during pregnancy. Women will be randomly assigned to an intervention group (i.e., Calm) or standard care group and asked to participate in at least 10 minutes of daily meditation for the duration of their pregnancy (i.e., 12-weeks' gestation up to date of birth).
Aim #1: Determine the feasibility (acceptability and demand) of using the Calm app at least 10-minutes per day for the duration of pregnancy (i.e., 12-weeks' gestation up to date of birth). Acceptability will be measured with an investigator-developed satisfaction survey.
Demand will be measured using time spent in meditation and meditations used (tracked by Calm).
For the intervention group, the benchmarks will be as follows:
- Acceptability (i.e., satisfaction) 70% (n=34) of participants will report a 75% satisfaction,
- Demand (i.e., time spent in meditation and meditations used,) 70% (n=34) of participants will adhere to ≥75% of prescribed meditation using Calm.
Aim #2: Determine the preliminary effects of using Calm at least 10-minutes per day for the duration of pregnancy (i.e., 12-16 weeks' gestation to date of birth) on stress. Stress will be measured using the Perceived Stress Scale (PSS) at baseline (i.e., 12-16-weeks' gestation) and every four weeks for the duration of the intervention using Ecological Momentary Assessment (i.e., text message). Stress will also be measured using cortisol serum at baseline (i.e., 12-16-weeks' gestation), and 32 weeks' gestation.
Exploratory Aim #3: The investigators will explore the preliminary effects of using Calm at least 10-minutes per day for the duration of pregnancy (i.e., 12-16 weeks' gestation to date of birth) on gestational age of birth, fetal weight, APGAR scores (i.e., health score), and neonatal complications with time spent in neonatal intensive unit (if applicable).
Detailed description
Enrollment: Interested participants at Valley Perinatal Clinics will be asked for their email and will be sent a link to a brief (5-10 minute) eligibility screener via RedCap (See Eligibility screener). Eligible participants will be asked to watch a brief intake video followed by a 3-question quiz and asked to sign an electronic informed consent prior to completing any further surveys. After informed consents have been completed, participants (N=97) will be identified. Participants will be asked to complete a baseline questionnaire (See Surveys and Questionnaires document) and complete a medical history form, which will ask participants to include a history of medications. They also will be asked to sign a medical release form for their obstetrician. Ineligible participants will be notified by email according to the script (See Email Scripts document).
Randomization: Participants will be randomized into either the intervention (Calm App) or standard prenatal care control and given further instructions to begin participating (See Welcome Email in Email Scripts document).
Inclusion criteria are: (1) women 12-16 weeks pregnant, (2) >18 years of age, (3) English speaking, (3) not currently on steroid therapy, (4) willing to download the Calm app to their smartphone, and (5) have not practiced meditation or mindful movement more than 60 minutes a month in the past six months (6) willing to be randomized to one of two groups.
Control: The control group will be asked to maintain normal activity and refrain from using Calm meditation app.
Intervention: Participants (n=49) will be provided free access to and asked to register for the consumer-based mobile meditation app on their phone. Participants (n=49) will then receive an email containing 28 weeks of free access to Calm. Participants (n=49) will be asked to use Calm at least 10 minutes per day and encouraged to use it as much as they would like during the intervention. This prescription mimics how a new, paying member would use the app (full exposure with autonomy).
Meditation Tracking: Intervention participants (n=49) usage will be continuously tracked throughout the intervention by Calm.
Assessments: Intervention group participants will receive self-report questionnaires (via RedCap) at baseline, and post intervention only after informed consent has been is obtained. Included within these questionnaires the investigators will measure demographics (baseline only) and stress (using the Perceived Stress Scale), mindfulness (using the Mindfulness Attention Awareness Scale), depression (using the Edinburgh Postnatal Depression Scale), anxiety (using the Pregnancy Related Anxiety Questionnaire), self-compassion (using the Self-Compassion Scale), emotional regulation (using the Difficulties in Emotional Regulations Scale), gratitude (using the Gratitude During Pregnancy Scale), and childbirth experience (using the Childbirth Experience Questionnaire). Every four weeks for the duration of the intervention, the investigators will measure stress and mindfulness using Ecological Momentary Assessment (i.e., text message). At baseline, mid-intervention (24-26 weeks' gestation), and baseline (32-34 weeks' gestations) depression, anxiety, self-compassion, emotional regulation, and gratitude will be measured. After the baby is born, depression, anxiety, self-compassion, emotional regulation, and childbirth experience will be measured.
Stress will also be measured using cortisol serum at baseline (i.e., 12-16-weeks' gestation) and 32 weeks. These tests will be performed at no additional cost to the participant. The blood draws will be completed at Valley Perinatal Clinic by a trained employee of Valley Perinatal Clinic. No more than one tube (10 mL) of blood will be taken for the cortisol serum test.
A weekly log (via RedCap) recording any changes in medications will be sent to participants. Any changes in medications, specifically ISSRs, will be accounted for in data analysis.
Acceptability is dually defined as participant satisfaction with content (i.e., Calm) and perceived appropriateness and usefulness of the behavioral components (i.e., reminders, self-monitoring) for self-management. Acceptability will be measured with an investigator-developed satisfaction survey, included within the post intervention questionnaire. Acceptability will be defined as 70% (n=34) of participants reporting a 75% satisfaction.
Demand will be measured by compliance to the >10 mins/day and sustained use during pregnancy. Demand (i.e., time spent in meditation and meditations used) will be defined as 70% (n=34) of participants adhering to ≥75% of prescribed meditation using Calm. Demand will be measured by Calm (internally) and shared with Arizona State University.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calm Meditation | Experimental | Behavioral: Calm AppParticipants (n=49) will be provided free access to and asked to register for the consumer-based mobile meditation app on their phone. Participants (n=49) will then receive an email containing 28 weeks of free access to Calm. Participants (n=49) will be asked to use Calm at least 10 minutes per day and encouraged to use it as much as they would like during the intervention. This prescription mimics how a new, paying member would use the app (full exposure with autonomy). |
| Control | No intervention | –The control group will be asked to maintain normal activity and refrain from using Calm meditation app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- women 12-16 weeks pregnant
- 18 years of age
- English speaking
- not currently on steroid therapy
- willing to download the Calm app to their smartphone,
Key exclusion criteria (1 listed)
- N/A
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 subscription-based meditation app which provides guided meditations, sleep stories, soundscapes and calming music. Calm offers 7 Days of Calm for those new to meditation, the daily Calm, a meditation posted daily and a library of unique 10-12 minute meditations with topics related to acceptance, anxiety, self-compassion, and physical pain (to name a few). | Behavioural | Calm Meditation |
Primary outcome
Feasibility: Acceptability
Time frame: Two weeks after delivery of baby
Acceptability will be measured with an investigator developed survey
Feasibility: Demand (Time spent in meditation and meditations used)
Time frame: At birth/delivery
Demand will be gathered using meditation app usage data and defined as at least 70% of intervention group will adhere to at 75% of prescribed meditation
1 secondary outcome
Perceived Stress of Participant
Time frame: baseline, 16, 20, 24, 28, 32, and 36 weeks' gestation, two weeks after delivery of baby
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pregnant Women, run by Arizona State University 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 19 Jul 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility: Acceptability (time frame: Two weeks after delivery of baby). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2022.