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Intervention for Pregnancy

N/A
Waitlist Available
Research Sponsored by Calm.com, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks
Awards & highlights

Study 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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Anxiety (Pregnancy Related Anxiety Questionnaire)
Change in Depressive Symptoms (Edinburgh Postnatal Depression Scale)
Change in Sleep Quality (Pittsburgh Sleep Quality Index)
+1 more
Secondary outcome measures
Self-Reported Baby's Birth Weight
Self-Reported Baby's Gestational Age at Birth
Self-reported Childbirth Experience

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
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)
Group II: ControlActive Control1 Intervention
Participants (n=90) will be asked to continue with usual care and complete survey measures at each time point.

Find a Location

Who is running the clinical trial?

Calm.com, Inc.Lead Sponsor
6 Previous Clinical Trials
1,364 Total Patients Enrolled
Jen Huberty, PhDStudy DirectorCalm.com, Inc.
1 Previous Clinical Trials
137 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
Florida
Other
California
How old are they?
18 - 65
What site did they apply to?
Calm, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Feasibility of Calm to Reduce Stress and Improve Sleep During Pregnancy
2022. "Feasibility of Calm to Reduce Stress and Improve Sleep During Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05285956.
~1 spots leftby Apr 2025
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