Mindfulness in Pregnancy

Not Applicable

• Conditions: Mindfulness; Anxiety; Depression
• Interventions: Behavioral: Mindfulness Auditory Intervention

• Registration Number: NCT03635697
• Lead Sponsor: UConn Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-17
• Study Start: 2018-10-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-08-30
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Intervention Group	Mindfulness Auditory Intervention	Participants in this group will listen to a short mindfulness audio clip during 6 of their NST appointments.

Primary Outcome Measures

Name	Time	Method
Beck Anxiety Inventory Score	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	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.

Trial Locations

Locations (1)

UConn Health / John Dempsey Hospital; 🇺🇸 Farmington, Connecticut, United States