Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04264910 |
| Other study ID # |
STUDY00010467 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2019 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
Arizona State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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:
1. Acceptability (i.e., satisfaction) 70% (n=34) of participants will report a 75%
satisfaction,
2. 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).
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.
