Mindfulness in Pregnancy

Sponsor

UConn Health (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03635697

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depression Mindfulness	Behavioral: Mindfulness Auditory Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Aug 30, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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