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

Depression, Postpartum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02843022
• Other study ID #: NURS2015-3
• Status: Completed
• Phase: N/A
• First received: July 20, 2016
• Last updated: April 19, 2018
• Start date: November 2015
• Est. completion date: February 2018

Study information

• Verified date: April 2018
• Source: Saint Anselm College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 683
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

Behavioral:
• standardized electronic messages
supportive and educational short messages
• 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
• 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.

Locations

Country	Name	City	State
United States	Catholic Medical Center	Manchester	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Saint Anselm College	Catholic Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (24)

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. — View Citation

Aguilera A, Muñoz 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. — View Citation

Beck A, Crain AL, Solberg LI, Unützer 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. — View 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.

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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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.

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. — View 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. — View 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. Epub 2005 May 11. Review. — View 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. — View Citation

McLennan JD, Kotelchuck M. Parental prevention practices for young children in the context of maternal depression. Pediatrics. 2000 May;105(5):1090-5. — View 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. — View 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. — View 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.

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. — View 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. Epub 2007 Feb 13. — View 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. — View 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. — View 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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postpartum depression symptoms	Measured by scores on the Edinburgh Postnatal Depression Scale (EPDS) at three time points	6 months postpartum
Secondary	breastfeeding outcomes	Duration and pattern of infant feeding	6 months postpartum
Secondary	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	6 months postpartum
Secondary	Parenting stress	Scores on the Parenting Stress Index (PSI-4)	6 months postpartum

External Links

•   Identifying and treating maternal depression