Text Size

Using a Preparation and Education Intervention to Reduce Postpartum Depression Among New Mothers (The MADE IT 2 Study)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00951717
First received: August 3, 2009
Last updated: November 18, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Depression, Postpartum
Depression
 Behavioral: Behavioral education intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preparation and Patient Education to Reduce Postpartum Depressive Symptoms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: Measured at baseline ] [ Designated as safety issue: Yes ]
  • Depressive symptoms [ Time Frame: Measured at 3 weeks ] [ Designated as safety issue: Yes ]
  • Depressive symptoms [ Time Frame: Measured at 3 months ] [ Designated as safety issue: Yes ]
  • Depressive symptoms [ Time Frame: Measured at 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Breastfeeding continuation rate [ Time Frame: Measured at baseline ] [ Designated as safety issue: Yes ]
  • Breastfeeding continuation rate [ Time Frame: Measured at 3 weeks ] [ Designated as safety issue: Yes ]
  • Breastfeeding continuation rate [ Time Frame: Measured at 3 months ] [ Designated as safety issue: Yes ]
  • Breastfeeding continuation rate [ Time Frame: Measured at 6 months ] [ Designated as safety issue: Yes ]
  • Physical functioning [ Time Frame: Measured at baseline ] [ Designated as safety issue: Yes ]
  • Physical functioning [ Time Frame: Measured at 3 weeks ] [ Designated as safety issue: Yes ]
  • Physical functioning [ Time Frame: Measured at 3 months ] [ Designated as safety issue: Yes ]
  • Physical functioning [ Time Frame: Measured at 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 590
Study Start Date: July 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment as usual
Participants will receive standard postpartum education and discharge materials provided by the hospital and a list of community and Internet resources by mail.
Experimental: Behavioral education
Participants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail.
 Behavioral: Behavioral education intervention
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951717

Locations
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Elizabeth Howell, MD, MPP Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00951717     History of Changes
Other Study ID Numbers: 05-1062, R01MH077683, DSIR 83-ATP
Study First Received: August 3, 2009
Last Updated: November 18, 2011
Health Authority: United States: Federal Government

Keywords provided by Mount Sinai School of Medicine:
Postpartum Depressive Symptoms
Physical Symptoms
Emotional Symptoms
 Infant Colic
Social Support
Breastfeeding

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on May 16, 2013