Using a Preparation and Education Intervention to Reduce Postpartum Depression Among New Mothers (The MADE IT 2 Study)
Primary Purpose
Depression, Postpartum, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral education intervention
Sponsored by
About this trial
This is an interventional prevention trial for Depression, Postpartum focused on measuring Postpartum Depressive Symptoms, Physical Symptoms, Emotional Symptoms, Infant Colic, Social Support, Breastfeeding
Eligibility Criteria
Inclusion Criteria:
- Patient in the Maternity Unit at Mount Sinai Hospital
- Infant has a birth weight greater than or equal to 2,500 grams
- Infant has a 5-minute Apgar score greater than or equal to 7
- Self-identifies as White or minority other than Black or Hispanic; Black and Hispanic women will be referred to a parallel study with the same protocol at Mount Sinai Hospital
- Speaks English
- Has a working telephone
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment as usual
Behavioral education
Arm Description
Participants will receive standard postpartum education and discharge materials provided by the hospital and a list of community and Internet resources by mail.
Participants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail.
Outcomes
Primary Outcome Measures
Depressive symptoms
Depressive symptoms
Depressive symptoms
Depressive symptoms
Secondary Outcome Measures
Breastfeeding continuation rate
Breastfeeding continuation rate
Breastfeeding continuation rate
Breastfeeding continuation rate
Physical functioning
Physical functioning
Physical functioning
Physical functioning
Full Information
NCT ID
NCT00951717
First Posted
August 3, 2009
Last Updated
November 18, 2011
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00951717
Brief Title
Using a Preparation and Education Intervention to Reduce Postpartum Depression Among New Mothers (The MADE IT 2 Study)
Official Title
Preparation and Patient Education to Reduce Postpartum Depressive Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will test an intervention that aims to prevent postpartum depression by providing new mothers with information on and resources for dealing with the disorder.
Detailed Description
Postpartum depression (PPD) is a disorder affecting many women after delivery of a child. Up to 50% of mothers may experience some depressive symptoms after giving birth, and up to 25% of them will develop major depressive disorder. Some situational factors that place mothers at risk of PPD may be changed or minimized, including social support, the mother's efficiency in handling situational stress, and distress from physical symptoms. Preparing mothers to identify potential situational triggers of depressive symptoms, enhancing their postpartum self-management skills, and providing them access to the proper social and healthcare resources may prevent them from developing major depression. This study will test the efficacy of a brief intervention that aims to prevent PPD by preparing mothers to deal with stressful triggers and depressive symptoms.
This study will last 6 months. Participants will be randomly assigned to receive either treatment as usual or the behavioral education intervention. The intervention will involve two parts. First, after giving birth and while still in the hospital, participants will complete an education session with a social worker and receive written materials about PPD. Then, 2 weeks after discharge from the hospital, participants will receive a call from the social worker, who will conduct a needs assessment that addresses participants' physical and emotional health. If a participant is experiencing distress, the social worker will refer her to appropriate resources and will reinforce self-management skills. All participants will receive a list of community and hospital resources by mail.
Study assessments will take place at 3 weeks, 3 months, and 6 months after study entry. At these points, participants will complete a 20-minute phone survey with a research assistant about their health, mood, and basic demographic information.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum, Depression
Keywords
Postpartum Depressive Symptoms, Physical Symptoms, Emotional Symptoms, Infant Colic, Social Support, Breastfeeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
590 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Participants will receive standard postpartum education and discharge materials provided by the hospital and a list of community and Internet resources by mail.
Arm Title
Behavioral education
Arm Type
Experimental
Arm Description
Participants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral education intervention
Intervention Description
One education session with a social worker while at the hospital, provision of an educational pamphlet and summary sheet for partner, a needs assessment by the social worker 2 weeks after hospital discharge, and additional patient education and reinforcement of self-management skills, as needed
Primary Outcome Measure Information:
Title
Depressive symptoms
Time Frame
Measured at baseline
Title
Depressive symptoms
Time Frame
Measured at 3 weeks
Title
Depressive symptoms
Time Frame
Measured at 3 months
Title
Depressive symptoms
Time Frame
Measured at 6 months
Secondary Outcome Measure Information:
Title
Breastfeeding continuation rate
Time Frame
Measured at baseline
Title
Breastfeeding continuation rate
Time Frame
Measured at 3 weeks
Title
Breastfeeding continuation rate
Time Frame
Measured at 3 months
Title
Breastfeeding continuation rate
Time Frame
Measured at 6 months
Title
Physical functioning
Time Frame
Measured at baseline
Title
Physical functioning
Time Frame
Measured at 3 weeks
Title
Physical functioning
Time Frame
Measured at 3 months
Title
Physical functioning
Time Frame
Measured at 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient in the Maternity Unit at Mount Sinai Hospital
Infant has a birth weight greater than or equal to 2,500 grams
Infant has a 5-minute Apgar score greater than or equal to 7
Self-identifies as White or minority other than Black or Hispanic; Black and Hispanic women will be referred to a parallel study with the same protocol at Mount Sinai Hospital
Speaks English
Has a working telephone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Howell, MD, MPP
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27227751
Citation
Bodnar-Deren S, Klipstein K, Fersh M, Shemesh E, Howell EA. Suicidal Ideation During the Postpartum Period. J Womens Health (Larchmt). 2016 Dec;25(12):1219-1224. doi: 10.1089/jwh.2015.5346. Epub 2016 May 26.
Results Reference
derived
PubMed Identifier
25374288
Citation
Balbierz A, Bodnar-Deren S, Wang JJ, Howell EA. Maternal depressive symptoms and parenting practices 3-months postpartum. Matern Child Health J. 2015 Jun;19(6):1212-9. doi: 10.1007/s10995-014-1625-6.
Results Reference
derived
PubMed Identifier
24019052
Citation
Howell EA, Bodnar-Deren S, Balbierz A, Loudon H, Mora PA, Zlotnick C, Wang J, Leventhal H. An intervention to reduce postpartum depressive symptoms: a randomized controlled trial. Arch Womens Ment Health. 2014 Feb;17(1):57-63. doi: 10.1007/s00737-013-0381-8. Epub 2013 Sep 10.
Results Reference
derived
PubMed Identifier
22581378
Citation
Negron R, Martin A, Almog M, Balbierz A, Howell EA. Social support during the postpartum period: mothers' views on needs, expectations, and mobilization of support. Matern Child Health J. 2013 May;17(4):616-23. doi: 10.1007/s10995-012-1037-4.
Results Reference
derived
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Using a Preparation and Education Intervention to Reduce Postpartum Depression Among New Mothers (The MADE IT 2 Study)
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