Mindfulness in Pregnancy

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Anxiety; Mindfulness
• Intervention / Treatment: Behavioral: Mindfulness Auditory Intervention

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • UConn Health / John Dempsey Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Intervention Group; Participants in this group will listen to a short mindfulness audio clip during 6 of their NST appointments.	Behavioral: Mindfulness Auditory Intervention; 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.
No Intervention: Control Group; Participants in this group will have the regular standard of care for their NST appointments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Over the course of 6 intervention sessions, followed by 6 weeks postpartum

Collaborators and Investigators

• Sponsor: UConn Health
• Investigators: Principal Investigator: Christopher M Morosky, MD, UConn Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Pregnancy; Mindfulness; NST; Non-stress test
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Anxiety Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 18-226-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No