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Mindfulness in Pregnancy

Primary Purpose

Anxiety, Depression, Mindfulness

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Auditory Intervention
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Pregnancy, Mindfulness, Anxiety, Depression, NST, Non-stress test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • English as primary language
  • less than 36 weeks gestational age
  • at least 28 weeks gestational age

Exclusion Criteria:

  • 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

Sites / Locations

  • UConn Health / John Dempsey Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness Intervention Group

Control Group

Arm Description

Participants in this group will listen to a short mindfulness audio clip during 6 of their NST appointments.

Participants in this group will have the regular standard of care for their NST appointments.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2018
Last Updated
October 6, 2020
Sponsor
UConn Health
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1. Study Identification

Unique Protocol Identification Number
NCT03635697
Brief Title
Mindfulness in Pregnancy
Official Title
The Effect of an Auditory Mindfulness Intervention During NST Appointments on Depression and Anxiety in Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Mindfulness
Keywords
Pregnancy, Mindfulness, Anxiety, Depression, NST, Non-stress test

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Intervention Group
Arm Type
Experimental
Arm Description
Participants in this group will listen to a short mindfulness audio clip during 6 of their NST appointments.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in this group will have the regular standard of care for their NST appointments.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Auditory Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beck Anxiety Inventory Score
Description
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.
Time Frame
Over the course of 6 intervention sessions, followed by 6 weeks postpartum
Title
Edinburgh Postnatal Depression Scale Score
Description
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.
Time Frame
Over the course of 6 intervention sessions, followed by 6 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older English as primary language less than 36 weeks gestational age at least 28 weeks gestational age Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher M Morosky, MD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health / John Dempsey Hospital
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mindfulness in Pregnancy

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