Effectiveness of a Web-based Nursing Intervention in the Reduction of Postpartum Depression and Parenting Stress.
2018年4月19日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
介入
入学 (実際)
683
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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New Hampshire
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Manchester、New Hampshire、アメリカ、03102
- Catholic Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
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 -
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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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実験的：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
他の名前：
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実験的：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
他の名前：
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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postpartum depression symptoms
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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breastfeeding outcomes
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Deborah E. McCarter, PhD, RN、Saint Anselm College
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年11月1日
一次修了 (実際)
2018年2月1日
研究の完了 (実際)
2018年2月1日
試験登録日
最初に提出
2016年7月20日
QC基準を満たした最初の提出物
2016年7月20日
最初の投稿 (見積もり)
2016年7月25日
学習記録の更新
投稿された最後の更新 (実際)
2018年4月23日
QC基準を満たした最後の更新が送信されました
2018年4月19日
最終確認日
2018年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Staff nurse phone follow-upの臨床試験
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University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了