Mindfulness in Pregnancy

NCT03635697 | Terminated

• 1 other identifier: 18-226-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Mindfulness

Keywords

Pregnancy; Mindfulness; Anxiety; Depression; NST; Non-stress test

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Mindfulness Intervention Group

EXPERIMENTAL

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

Behavioral: Mindfulness Auditory Intervention

Control Group

NO INTERVENTION

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

Interventions

Mindfulness Auditory Intervention BEHAVIORAL

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.

Mindfulness Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

UConn Health / John Dempsey Hospital

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Christopher M Morosky, MD

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 17, 2018
• Study Start: October 1, 2018
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)