AnxietyNCT03635697
Mindfulness in Pregnancy
A study testing Mindfulness Auditory Intervention in people with Anxiety and Depression, run by UConn Health at 1 site in United States.
Trial summary
This study aims to determine if a short audio clip about mindfulness implemented during NST appointments can lower pregnant women's levels of anxiety and depression. Subjects will be placed into either the intervention group or a control group. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Depression, Mindfulness
- What is being tested?
- Mindfulness Auditory Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 25 Jan 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- English as primary language
- less than 36 weeks gestational age
- at least 28 weeks gestational age
Who cannot join
- Use of psychoactive medications
- Any psychiatric diagnosis with dissociative, hallucinatory, and/or delusional features
- History of suicide attempt or current suicidal ideations
- Uncontrolled substance abuse in the last 6 months
- Patients with hearing loss
- More than three no-shows to NST appointments
Trial locations and contacts
1 site in 1 country.
United States1 site
UConn Health / John Dempsey Hospital
Farmington, Connecticut, 06030
About this study
Official title: The Effect of an Auditory Mindfulness Intervention During NST Appointments on Depression and Anxiety in Pregnant Women
This study aims to determine if a short audio clip about mindfulness implemented during NST appointments can lower pregnant women's levels of anxiety and depression. Subjects will be placed into either the intervention group or a control group. The intervention group will be asked to listen to a short audio clip on mindfulness during their NST appointments, and the control group will receive the standard of care during NST appointments. Subjects will be asked to take two surveys about anxiety and depression three times throughout the study: before the intervention, after the intervention, and 6 weeks postpartum.
- Conditions
- Anxiety, Depression, Mindfulness
- Being tested
- Mindfulness Auditory Intervention
- Keywords
- Pregnancy, Mindfulness, Anxiety, Depression, NST, Non-stress test
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Auditory InterventionBehavioural
This intervention is a short audio clip that focuses on the practices and principles of mindfulness. The goal of mindfulness is to bring awareness to a person's physical body as well as their thoughts and feelings.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention Group | Experimental | Participants in this group will listen to a short mindfulness audio clip during 6 of their NST appointments. Receives: Behavioral: Mindfulness Auditory Intervention |
| Control Group | No intervention | Participants in this group will have the regular standard of care for their NST appointments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory Score
We are looking for the members of our intervention group to see a change in their scores on the Beck Anxiety Inventory after completing 6 sessions of listening to a mindfulness clip. We expect to see this score change after the full-course of the intervention is complete. We also hope to see this change in score persist at the 6-week postpartum visit. This scale aims to measure anxiety symptoms, and total scores range from 0-36. Lower scores indicate lower levels of anxiety symptoms, and thus a better outcome.
Measured: Over the course of 6 intervention sessions, followed by 6 weeks postpartum
Edinburgh Postnatal Depression Scale Score
We are looking for the members of our intervention group to see a change in their scores on the Edinburgh Postnatal Depression Scale after completing 6 sessions of listening to a mindfulness clip. We expect to see this score change after the intervention is complete. We also hope to see this change in score persist at the 6-week postpartum visit. This scale aims to measure depressive symptoms, and total scores range from 0-30. Lower scores indicate lower levels of depressive symptoms, and thus a better outcome.
Measured: Over the course of 6 intervention sessions, followed by 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Oct 2018
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Why it stopped: Due to COVID-19 and guideline changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher M Morosky, MD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635697
- Sponsor's protocol ID
- 18-226-1
- Status last verified
- Jul 2025
- First submitted
- 14 Aug 2018
- Last updated
- 18 Jul 2025
- 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Auditory Mindfulness Intervention During NST Appointments on Depression and Anxiety in Pregnant Women
- ClinicalTrials.gov ID
- NCT03635697
- Acronym / sponsor ID
- 18-226-1
- Conditions
- Anxiety, Depression, Mindfulness
- Keywords
- Pregnancy, Mindfulness, Anxiety, Depression, NST, Non-stress test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 and guideline changed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 17 Aug 2018 (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.
This study aims to determine if a short audio clip about mindfulness implemented during NST appointments can lower pregnant women's levels of anxiety and depression. Subjects will be placed into either the intervention group or a control group. The intervention group will be asked to listen to a short audio clip on mindfulness during their NST appointments, and the control group will receive the standard of care during NST appointments. Subjects will be asked to take two surveys about anxiety and depression three times throughout the study: before the intervention, after the intervention, and 6 weeks postpartum.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention Group | Experimental | Behavioral: Mindfulness Auditory InterventionParticipants in this group will listen to a short mindfulness audio clip during 6 of their NST appointments. |
| Control Group | No intervention | –Participants in this group will have the regular standard of care for their NST appointments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- English as primary language
- less than 36 weeks gestational age
- at least 28 weeks gestational age
Key exclusion criteria (6 listed)
- Use of psychoactive medications
- Any psychiatric diagnosis with dissociative, hallucinatory, and/or delusional features
- History of suicide attempt or current suicidal ideations
- Uncontrolled substance abuse in the last 6 months
- Patients with hearing loss
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 |
|---|---|---|
| Mindfulness Auditory InterventionThis intervention is a short audio clip that focuses on the practices and principles of mindfulness. The goal of mindfulness is to bring awareness to a person's physical body as well as their thoughts and feelings. | Behavioural | Mindfulness Intervention Group |
Primary outcome
Beck Anxiety Inventory Score
Time frame: Over the course of 6 intervention sessions, followed by 6 weeks postpartum
We are looking for the members of our intervention group to see a change in their scores on the Beck Anxiety Inventory after completing 6 sessions of listening to a mindfulness clip. We expect to see this score change after the full-course of the intervention is complete. We also hope to see this change in score persist at the 6-week postpartum visit. This scale aims to measure anxiety symptoms, and total scores range from 0-36. Lower scores indicate lower levels of anxiety symptoms, and thus a better outcome.
Edinburgh Postnatal Depression Scale Score
Time frame: Over the course of 6 intervention sessions, followed by 6 weeks postpartum
We are looking for the members of our intervention group to see a change in their scores on the Edinburgh Postnatal Depression Scale after completing 6 sessions of listening to a mindfulness clip. We expect to see this score change after the intervention is complete. We also hope to see this change in score persist at the 6-week postpartum visit. This scale aims to measure depressive symptoms, and total scores range from 0-30. Lower scores indicate lower levels of depressive symptoms, and thus a better outcome.
Results and safety
The study was stopped early (reason given: Due to COVID-19 and guideline changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- 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.
Christopher M Morosky, MD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Auditory Intervention in people with Anxiety and Depression, run by UConn Health 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 4 inclusion and 6 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 18 Jul 2025. 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: Due to COVID-19 and guideline changed). 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?
Beck Anxiety Inventory Score (time frame: Over the course of 6 intervention sessions, followed by 6 weeks postpartum). 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 18 Jul 2025.