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

Primary Purpose

Depression, Postpartum

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standardized electronic messages
nurse phone call if requested
Staff nurse phone follow-up
Sponsored by
Saint Anselm College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression, Postpartum focused on measuring postpartum, nursing, follow-up

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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 -

Sites / Locations

  • Catholic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Usual care

Message Only

Message and Nurse

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

postpartum depression symptoms
Measured by scores on the Edinburgh Postnatal Depression Scale (EPDS) at three time points

Secondary Outcome Measures

breastfeeding outcomes
Duration and pattern of infant feeding
patient satisfaction/experience
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
Parenting stress
Scores on the Parenting Stress Index (PSI-4)

Full Information

First Posted
July 20, 2016
Last Updated
April 19, 2018
Sponsor
Saint Anselm College
Collaborators
Catholic Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02843022
Brief Title
Effectiveness of a Web-based Nursing Intervention in the Reduction of Postpartum Depression and Parenting Stress.
Official Title
Enhancing Follow-up Mechanisms for Women at Risk for Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Anselm College
Collaborators
Catholic Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum
Keywords
postpartum, nursing, follow-up

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
683 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Message Only
Arm Type
Experimental
Arm Description
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.
Arm Title
Message and Nurse
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
standardized electronic messages
Other Intervention Name(s)
text messages, email messages
Intervention Description
supportive and educational short messages
Intervention Type
Behavioral
Intervention Name(s)
nurse phone call if requested
Intervention Description
If participant responds "yes" to an offer for a phone call, a nurse calls them within a week of this response
Intervention Type
Behavioral
Intervention Name(s)
Staff nurse phone follow-up
Intervention Description
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 Measure Information:
Title
postpartum depression symptoms
Description
Measured by scores on the Edinburgh Postnatal Depression Scale (EPDS) at three time points
Time Frame
6 months postpartum
Secondary Outcome Measure Information:
Title
breastfeeding outcomes
Description
Duration and pattern of infant feeding
Time Frame
6 months postpartum
Title
patient satisfaction/experience
Description
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
Time Frame
6 months postpartum
Title
Parenting stress
Description
Scores on the Parenting Stress Index (PSI-4)
Time Frame
6 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to speak and read English Access to a device which can receive text or email messages Exclusion Criteria: Non-English speaking, No access to a device which can receive text or email messages Age younger than 18 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah E. McCarter, PhD, RN
Organizational Affiliation
Saint Anselm College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20706098
Citation
Segre LS, O'Hara MW, Arndt S, Beck CT. Screening and counseling for postpartum depression by nurses: the women's views. MCN Am J Matern Child Nurs. 2010 Sep-Oct;35(5):280-5. doi: 10.1097/NMC.0b013e3181e62679.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
26126933
Citation
Mood and Anxiety Disorders in Pregnant and Postpartum Women. J Obstet Gynecol Neonatal Nurs. 2015 Sep-Oct;44(5):687-9. doi: 10.1111/1552-6909.12734. Epub 2015 Jun 30. No abstract available.
Results Reference
background
PubMed Identifier
17370048
Citation
Segre LS, O'Hara MW, Arndt S, Stuart S. The prevalence of postpartum depression: the relative significance of three social status indices. Soc Psychiatry Psychiatr Epidemiol. 2007 Apr;42(4):316-21. doi: 10.1007/s00127-007-0168-1. Epub 2007 Feb 13.
Results Reference
background
PubMed Identifier
15883651
Citation
Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. doi: 10.1007/s00737-005-0080-1. Epub 2005 May 11.
Results Reference
background
PubMed Identifier
20974776
Citation
Earls MF; Committee on Psychosocial Aspects of Child and Family Health American Academy of Pediatrics. Incorporating recognition and management of perinatal and postpartum depression into pediatric practice. Pediatrics. 2010 Nov;126(5):1032-9. doi: 10.1542/peds.2010-2348. Epub 2010 Oct 25.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
16882821
Citation
Paulson JF, Dauber S, Leiferman JA. Individual and combined effects of postpartum depression in mothers and fathers on parenting behavior. Pediatrics. 2006 Aug;118(2):659-68. doi: 10.1542/peds.2005-2948.
Results Reference
background
PubMed Identifier
10790467
Citation
McLennan JD, Kotelchuck M. Parental prevention practices for young children in the context of maternal depression. Pediatrics. 2000 May;105(5):1090-5. doi: 10.1542/peds.105.5.1090.
Results Reference
background
PubMed Identifier
17403826
Citation
Sills MR, Shetterly S, Xu S, Magid D, Kempe A. Association between parental depression and children's health care use. Pediatrics. 2007 Apr;119(4):e829-36. doi: 10.1542/peds.2006-2399.
Results Reference
background
PubMed Identifier
21747101
Citation
Beck A, Crain AL, Solberg LI, Unutzer J, Glasgow RE, Maciosek MV, Whitebird R. Severity of depression and magnitude of productivity loss. Ann Fam Med. 2011 Jul-Aug;9(4):305-11. doi: 10.1370/afm.1260.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
17478661
Citation
Gjerdingen DK, Yawn BP. Postpartum depression screening: importance, methods, barriers, and recommendations for practice. J Am Board Fam Med. 2007 May-Jun;20(3):280-8. doi: 10.3122/jabfm.2007.03.060171.
Results Reference
background
PubMed Identifier
27128643
Citation
McCarter-Spaulding D, Shea S. Effectiveness of Discharge Education on Postpartum Depression. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):168-72. doi: 10.1097/NMC.0000000000000236.
Results Reference
background
PubMed Identifier
25295667
Citation
Furber G, Jones GM, Healey D, Bidargaddi N. A comparison between phone-based psychotherapy with and without text messaging support in between sessions for crisis patients. J Med Internet Res. 2014 Oct 8;16(10):e219. doi: 10.2196/jmir.3096.
Results Reference
background
PubMed Identifier
25525292
Citation
Aguilera A, Munoz RF. Text Messaging as an Adjunct to CBT in Low-Income Populations: A Usability and Feasibility Pilot Study. Prof Psychol Res Pr. 2011 Dec 1;42(6):472-478. doi: 10.1037/a0025499.
Results Reference
background
PubMed Identifier
25373390
Citation
Aguilera A, Berridge C. Qualitative feedback from a text messaging intervention for depression: benefits, drawbacks, and cultural differences. JMIR Mhealth Uhealth. 2014 Nov 5;2(4):e46. doi: 10.2196/mhealth.3660.
Results Reference
background
PubMed Identifier
18278545
Citation
Le HN, Perry DF, Sheng X. Using the internet to screen for postpartum depression. Matern Child Health J. 2009 Mar;13(2):213-21. doi: 10.1007/s10995-008-0322-8. Epub 2008 Feb 16.
Results Reference
background
PubMed Identifier
23283485
Citation
Drake E, Howard E, Kinsey E. Online screening and referral for postpartum depression: an exploratory study. Community Ment Health J. 2014 Apr;50(3):305-11. doi: 10.1007/s10597-012-9573-3. Epub 2013 Jan 3.
Results Reference
background
PubMed Identifier
23612274
Citation
Danaher BG, Milgrom J, Seeley JR, Stuart S, Schembri C, Tyler MS, Ericksen J, Lester W, Gemmill AW, Lewinsohn P. Web-Based Intervention for Postpartum Depression: Formative Research and Design of the MomMoodBooster Program. JMIR Res Protoc. 2012 Nov 22;1(2):e18. doi: 10.2196/resprot.2329.
Results Reference
background
PubMed Identifier
20884642
Citation
Leung SS, Leung C, Lam TH, Hung SF, Chan R, Yeung T, Miao M, Cheng S, Leung SH, Lau A, Lee DT. Outcome of a postnatal depression screening programme using the Edinburgh Postnatal Depression Scale: a randomized controlled trial. J Public Health (Oxf). 2011 Jun;33(2):292-301. doi: 10.1093/pubmed/fdq075. Epub 2010 Sep 29.
Results Reference
background
PubMed Identifier
18689530
Citation
Sword W, Busser D, Ganann R, McMillan T, Swinton M. Women's care-seeking experiences after referral for postpartum depression. Qual Health Res. 2008 Sep;18(9):1161-73. doi: 10.1177/1049732308321736.
Results Reference
background
PubMed Identifier
21372647
Citation
Senti J, LeMire SD. Patient satisfaction with birthing center nursing care and factors associated with likelihood to recommend institution. J Nurs Care Qual. 2011 Apr-Jun;26(2):178-85. doi: 10.1097/NCQ.0b013e3181fe93e6.
Results Reference
background
PubMed Identifier
19336362
Citation
Dennis CL, McQueen K. The relationship between infant-feeding outcomes and postpartum depression: a qualitative systematic review. Pediatrics. 2009 Apr;123(4):e736-51. doi: 10.1542/peds.2008-1629.
Results Reference
background
PubMed Identifier
31222789
Citation
McCarter DE, Demidenko E, Sisco TS, Hegel MT. Technology-assisted nursing for postpartum support: A randomized controlled trial. J Adv Nurs. 2019 Oct;75(10):2223-2235. doi: 10.1111/jan.14114. Epub 2019 Jul 21.
Results Reference
derived
Links:
URL
https://www.apa.org/pi/about/publications/caregivers/practice-settings/assessment/tools/parenting-stress.aspx
Description
Parenting Stress Index

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

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