Effectiveness of a Web-based Nursing Intervention in the Reduction of Postpartum Depression and Parenting Stress.

April 19, 2018 updated by: Saint Anselm College

Enhancing Follow-up Mechanisms for Women at Risk for Postpartum Depression

The purpose of the study is to determine whether a web-based nursing intervention delivered during the postpartum period will decrease symptoms of postpartum depression and parenting stress.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this randomized, controlled trial is to determine whether receiving standardized messages (text or email) from a postpartum nurse four times/week for 6 months after delivery will decrease symptoms of postpartum depression and parenting stress. Enrolled women will be randomized to one of three groups. The first group will receive the usual care, which is a phone call from a nurse within the first few weeks postpartum. The second group will receive four standardized messages each week, the content of which will include infant care, maternal self-care and inspirational material. The third group will receive the same four standardized messages each week, and in addition, two of these weekly messages will offer the option to respond with a request for a nurse to call them. Baseline data will be collected during the postpartum hospitalization, and follow-up will occur by email at 3 weeks, 3 months and 6 months postpartum.

Study Type

Interventional

Enrollment (Actual)

683

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Manchester, New Hampshire, United States, 03102
        • Catholic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Able to speak and read English
  2. Access to a device which can receive text or email messages

Exclusion Criteria:

  1. Non-English speaking,
  2. No access to a device which can receive text or email messages
  3. Age younger than 18 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care
Participant will receive the usual care provided by the nursing staff at Catholic Medical Center. A lactation consultant or childbirth educator attempts to call each patient within 2-3 weeks prior to discharge. Only one call is made, and a message left if the patient would like to call back.
Behavioral: Staff nurse phone follow-up
Usual care: hospital nurse or lactation consultant calls patient within 2-3 weeks prior to discharge. Message left if patient is not reached.
Experimental: Message Only
Participant will receive the usual care, and in addition, will receive four standardized electronic messages weekly for six months postpartum. These will be one-way messages without the option to respond.
Behavioral: Staff nurse phone follow-up
Usual care: hospital nurse or lactation consultant calls patient within 2-3 weeks prior to discharge. Message left if patient is not reached.
Behavioral: standardized electronic messages
supportive and educational short messages
Other Names:
  • text messages
  • email messages
Experimental: Message and Nurse
Participant will receive the usual care as well as the four standardized electronic messages/week for 6 months. Two of these weekly messages will be two-way, providing the option for the participant to respond "yes" to an offer to have a nurse call them. A nurse phone call if requested will be provided with a week.
Behavioral: Staff nurse phone follow-up
Usual care: hospital nurse or lactation consultant calls patient within 2-3 weeks prior to discharge. Message left if patient is not reached.
Behavioral: standardized electronic messages
supportive and educational short messages
Other Names:
  • text messages
  • email messages
Behavioral: nurse phone call if requested
If participant responds "yes" to an offer for a phone call, a nurse calls them within a week of this response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postpartum depression symptoms
Time Frame: 6 months postpartum
Measured by scores on the Edinburgh Postnatal Depression Scale (EPDS) at three time points
6 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breastfeeding outcomes
Time Frame: 6 months postpartum
Duration and pattern of infant feeding
6 months postpartum
patient satisfaction/experience
Time Frame: 6 months postpartum
Participant response to the experience of receiving messages and having the option to talk to a nurse (group 3), as well as their sense of connection to the hospital where they gave birth
6 months postpartum
Parenting stress
Time Frame: 6 months postpartum
Scores on the Parenting Stress Index (PSI-4)
6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Anselm College

Collaborators

Catholic Medical Center

Investigators

  • Principal Investigator: Deborah E. McCarter, PhD, RN, Saint Anselm College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 25, 2016

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NURS2015-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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