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

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ClinicalTrials.gov Identifier: NCT02843022
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Catholic Medical Center
Information provided by (Responsible Party):
Saint Anselm College

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression, Postpartum Behavioral: standardized electronic messages Behavioral: nurse phone call if requested Behavioral: Staff nurse phone follow-up Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 683 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Enhancing Follow-up Mechanisms for Women at Risk for Postpartum Depression
Study Start Date : November 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


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: standardized electronic messages
supportive and educational short messages
Other Names:
  • text messages
  • email messages

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 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: 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

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.




Primary Outcome Measures :
  1. postpartum depression symptoms [ Time Frame: 6 months postpartum ]
    Measured by scores on the Edinburgh Postnatal Depression Scale (EPDS) at three time points


Secondary Outcome Measures :
  1. breastfeeding outcomes [ Time Frame: 6 months postpartum ]
    Duration and pattern of infant feeding

  2. 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

  3. Parenting stress [ Time Frame: 6 months postpartum ]
    Scores on the Parenting Stress Index (PSI-4)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843022


Locations
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United States, New Hampshire
Catholic Medical Center
Manchester, New Hampshire, United States, 03102
Sponsors and Collaborators
Saint Anselm College
Catholic Medical Center
Investigators
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Principal Investigator: Deborah E. McCarter, PhD, RN Saint Anselm College
Additional Information:
Publications:
Piette JD, Schillinger D. Applying interactive health technologies for vulnerable populations. In: King TE, Wheeler MB, eds. Medical management of vulnerable and underserved patients: Principles, practice and populations. New York: McGraw-Hill; 2007.
Knitzer J, Theberge S, Johnson K. Reducing maternal depression and its impact on young children: Toward a responsive early childhood policy framework. Project Thrive 2008.
Brealey SD, Hewitt C, Green JM, Morrell J, Gilbody S. Screening for postnatal depression -- is it acceptable to women and healthcare professionals? A systematic review and meta-synthesis. Journal of Reproductive & Infant Psychology. 2010;28:328-344.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Saint Anselm College
ClinicalTrials.gov Identifier: NCT02843022    
Other Study ID Numbers: NURS2015-3
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Saint Anselm College:
postpartum
nursing
follow-up
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications