Mindfulness in Pregnancy

Depression Clinical Trial

Official title:

The Effect of an Auditory Mindfulness Intervention During NST Appointments on Depression and Anxiety in Pregnant Women

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03635697
• Other study ID #: 18-226-1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 2021

Study information

• Verified date: October 2020
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: October 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Mindfulness

Intervention

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.

Locations

Country	Name	City	State
United States	UConn Health / John Dempsey Hospital	Farmington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
UConn Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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