AzTrials
AzTrials

Depression, PostpartumNCT02843022

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

A study testing standardized electronic messages, nurse phone call if requested and Staff nurse phone follow-up in people with Depression, Postpartum, run by Saint Anselm College at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Depression, Postpartum
What is being tested?
standardized electronic messages, nurse phone call if requested and Staff nurse phone follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
683 participants
Where
1 siteUnited States
Study dates
Nov 2015to Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Able to speak and read English
  • Access to a device which can receive text or email messages

Who cannot join

  • Non-English speaking,
  • No access to a device which can receive text or email messages
  • Age younger than 18 -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
standardized electronic messages, nurse phone call if requested, Staff nurse phone follow-up
Keywords
postpartum, nursing, follow-up
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standardized electronic messagesBehavioural

    Also called text messages, email messages

    supportive and educational short messages

  • nurse phone call if requestedBehavioural

    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-upBehavioural

    Usual care: hospital nurse or lactation consultant calls patient within 2-3 weeks prior to discharge. Message left if patient is not reached.

Study groups in NCT02843022
Study groupRoleWhat they receive
Usual careActive comparatorParticipant 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.
Receives: Behavioral: Staff nurse phone follow-up
Message OnlyExperimentalParticipant 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.
Receives: Behavioral: standardized electronic messages; Behavioral: Staff nurse phone follow-up
Message and NurseExperimentalParticipant 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.
Receives: Behavioral: standardized electronic messages; Behavioral: nurse phone call if requested; Behavioral: Staff nurse phone follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postpartum depression symptoms

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

    Measured: 6 months postpartum

Secondary outcomes (3)

  1. breastfeeding outcomes

    Duration and pattern of infant feeding

    Measured: 6 months postpartum

  2. 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

    Measured: 6 months postpartum

  3. Parenting stress

    Scores on the Parenting Stress Index (PSI-4)

    Measured: 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
683 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02843022
Sponsor's protocol ID
NURS2015-3
Status last verified
Apr 2018
First submitted
20 Jul 2016
Last updated
23 Apr 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20706098

  • 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.

    PubMed 26126933

  • 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.

    PubMed 17370048

  • 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.

    PubMed 15883651

  • 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.

    PubMed 20974776

  • 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.

  • 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.

    PubMed 16882821

  • 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.

    PubMed 10790467

  • 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.

    PubMed 17403826

  • 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.

    PubMed 21747101

  • 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.

    PubMed 17478661

  • 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.

    PubMed 27128643

  • 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.

    PubMed 25295667

Questions about this trial

What is this clinical trial studying?

A study testing standardized electronic messages, nurse phone call if requested and Staff nurse phone follow-up in people with Depression, Postpartum, run by Saint Anselm College at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postpartum depression symptoms (time frame: 6 months postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02843022, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in