Prenatal StressCALMSNCT05087329
Mindfulness Practice in Pregnancy As an Intervention to Decrease Prenatal Stress During the COVID-19 Pandemic
A study testing Virtual Mindfulness Meditation in people with Prenatal Stress, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of the study is to examine whether a simple mindfulness intervention conducted via a virtual platform can reduce stress among pregnant women. 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
- Prenatal Stress
- What is being tested?
- Virtual Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 19 Sep 2024
- 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 between 16w0d-26w6d gestation with a single gestation who have had a confirmed dating ultrasound
- Only women with singleton gestations will be included because multiple gestation pregnancies introduce additional levels of stress and introduce confounding variables for the adverse composite pregnancy outcome that will be measured. As this is a study of pregnant patients, only women are included.
- English speaking
- The mindfulness meditation trainings have been scripted and recorded in English. Thus, to understand the recordings and participate in the courses it is necessary for all participants to speak English.
- Regular internet access through either phone, tablet or computer. a. Mindfulness meditations are administered via Zoom webinars so internet access is required. A proxy for internet access during recruitment will be confirmed by the inclusion of an email address in the electronic medical record (EMR).
Who cannot join
- Multiple gestations. This has been chosen as an exclusion criteria to limit confounding variables for the secondary outcome of composite adverse pregnancy events.
- Age < 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadephia, Pennsylvania, 19104
About this study
The purpose of the study is to examine whether a simple mindfulness intervention conducted via a virtual platform can reduce stress among pregnant women.
- Conditions
- Prenatal Stress
- Being tested
- Virtual Mindfulness Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Mindfulness MeditationBehavioural
Four week virtual mindfulness meditation course composed of four weekly group Zoom webinars during which participants will listen to a 15-20 minute pre-recorded meditation, facilitated by a study provider
| Study group | Role | What they receive |
|---|---|---|
| Virtual Mindfulness intervention | Experimental | Four weekly group Zoom webinars with a 15-20 minute pre-recorded meditation Receives: Behavioral: Virtual Mindfulness Meditation |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Maternal Stress
Change in score on Perceived Stress Scale (PSS)
Measured: 6 to 8 weeks
Secondary outcomes (2)
Composite score of maternal morbidity/pregnancy outcomes
Measured: 6 to 8 weeks post-delivery
Change in score on Edinburgh Postnatal Depression Scale
Measured: change between score at time of delivery and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start5 May 2021
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Why it stopped: additional studies in this specific population made continuing with RCT unnecessary so became a part of clinical care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal StressStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirstin Leitner, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087329
- Sponsor's protocol ID
- 843962
- Acronym
- CALMS
- Status last verified
- Feb 2024
- First submitted
- 19 Oct 2021
- Last updated
- 16 Oct 2024
- 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Practice in Pregnancy As an Intervention to Decrease Prenatal Stress During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05087329
- Acronym / sponsor ID
- CALMS / 843962
- Conditions
- Prenatal Stress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: additional studies in this specific population made continuing with RCT unnecessary so became a part of clinical care
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 21 Oct 2021 (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 the study is to examine whether a simple mindfulness intervention conducted via a virtual platform can reduce stress among pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Mindfulness intervention | Experimental | Behavioral: Virtual Mindfulness MeditationFour weekly group Zoom webinars with a 15-20 minute pre-recorded meditation |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women between 16w0d-26w6d gestation with a single gestation who have had a confirmed dating ultrasound
- English speaking
- Regular internet access through either phone, tablet or computer. a. Mindfulness meditations are administered via Zoom webinars so internet access is required. A proxy for internet access during recruitment will be confirmed by the inclusion of an email address in the electronic medical record (EMR).
Key exclusion criteria (2 listed)
- Multiple gestations. This has been chosen as an exclusion criteria to limit confounding variables for the secondary outcome of composite adverse pregnancy events.
- Age < 18
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 |
|---|---|---|
| Virtual Mindfulness MeditationFour week virtual mindfulness meditation course composed of four weekly group Zoom webinars during which participants will listen to a 15-20 minute pre-recorded meditation, facilitated by a study provider | Behavioural | Virtual Mindfulness intervention |
Primary outcome
Decrease in Maternal Stress
Time frame: 6 to 8 weeks
Change in score on Perceived Stress Scale (PSS)
2 secondary outcomes
Composite score of maternal morbidity/pregnancy outcomes
Time frame: 6 to 8 weeks post-delivery
Change in score on Edinburgh Postnatal Depression Scale
Time frame: change between score at time of delivery and 6 weeks
Results and safety
The study was stopped early (reason given: additional studies in this specific population made continuing with RCT unnecessary so became a part of clinical care). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- 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 Virtual Mindfulness Meditation in people with Prenatal Stress, run by University of Pennsylvania 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 5 inclusion and 2 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 16 Oct 2024. 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: additional studies in this specific population made continuing with RCT unnecessary so became a part of clinical care). 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?
Decrease in Maternal Stress (time frame: 6 to 8 weeks). 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 16 Oct 2024.