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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00951717
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : November 22, 2011
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Depression, Postpartum Depression Behavioral: Behavioral education intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 590 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preparation and Patient Education to Reduce Postpartum Depressive Symptoms
Study Start Date : July 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: Measured at baseline ]
  2. Depressive symptoms [ Time Frame: Measured at 3 weeks ]
  3. Depressive symptoms [ Time Frame: Measured at 3 months ]
  4. Depressive symptoms [ Time Frame: Measured at 6 months ]

Secondary Outcome Measures :
  1. Breastfeeding continuation rate [ Time Frame: Measured at baseline ]
  2. Breastfeeding continuation rate [ Time Frame: Measured at 3 weeks ]
  3. Breastfeeding continuation rate [ Time Frame: Measured at 3 months ]
  4. Breastfeeding continuation rate [ Time Frame: Measured at 6 months ]
  5. Physical functioning [ Time Frame: Measured at baseline ]
  6. Physical functioning [ Time Frame: Measured at 3 weeks ]
  7. Physical functioning [ Time Frame: Measured at 3 months ]
  8. Physical functioning [ Time Frame: Measured at 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00951717

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT00951717     History of Changes
Other Study ID Numbers: 05-1062
R01MH077683 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

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

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