Effectiveness of a Web-based Nursing Intervention in the Reduction of Postpartum Depression and Parenting Stress.
19. april 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
683
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New Hampshire
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Manchester, New Hampshire, Forente stater, 03102
- Catholic Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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 -
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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.
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Usual care: hospital nurse or lactation consultant calls patient within 2-3 weeks prior to discharge.
Message left if patient is not reached.
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Eksperimentell: 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.
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Usual care: hospital nurse or lactation consultant calls patient within 2-3 weeks prior to discharge.
Message left if patient is not reached.
supportive and educational short messages
Andre navn:
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Eksperimentell: 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.
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Usual care: hospital nurse or lactation consultant calls patient within 2-3 weeks prior to discharge.
Message left if patient is not reached.
supportive and educational short messages
Andre navn:
If participant responds "yes" to an offer for a phone call, a nurse calls them within a week of this response
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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postpartum depression symptoms
Tidsramme: 6 months postpartum
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Measured by scores on the Edinburgh Postnatal Depression Scale (EPDS) at three time points
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6 months postpartum
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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breastfeeding outcomes
Tidsramme: 6 months postpartum
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Duration and pattern of infant feeding
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6 months postpartum
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patient satisfaction/experience
Tidsramme: 6 months postpartum
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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
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6 months postpartum
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Parenting stress
Tidsramme: 6 months postpartum
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Scores on the Parenting Stress Index (PSI-4)
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6 months postpartum
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Deborah E. McCarter, PhD, RN, Saint Anselm College
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2015
Primær fullføring (Faktiske)
1. februar 2018
Studiet fullført (Faktiske)
1. februar 2018
Datoer for studieregistrering
Først innsendt
20. juli 2016
Først innsendt som oppfylte QC-kriteriene
20. juli 2016
Først lagt ut (Anslag)
25. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. april 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. april 2018
Sist bekreftet
1. april 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NURS2015-3
Plan for individuelle deltakerdata (IPD)
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