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Translating Research Into Practice for Postpartum Depression (TRIPPD)

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.
 
ClinicalTrials.gov Identifier: NCT00548743
Recruitment Status : Unknown
Verified October 2007 by Olmsted Medical Center.
Recruitment status was:  Recruiting
First Posted : October 24, 2007
Last Update Posted : December 4, 2007
Sponsor:
Information provided by:
Olmsted Medical Center

Study Description
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Brief Summary:

This is a study to assess the impact of introducing screening and planned follow up for postpartum depression. All women ages 18 to 45 who speak English or Spanish who come to the enrolled community family medicine offices will either be given usual care or screened using the Edinburgh Postnatal Depression Screening tool. If the EDPS score is high the women will be given the PHQ-9 to more clearly identify the specific likelihood of being depressed. Women who are determined to be depressed will be treated with medication or counseling based on the preference of the women and their physicians. Women will be followed through nurse initiated phone calls and visits to the physicians office.

Outcomes include the level of depression symptoms, measure of comfort with parenting, and satisfaction with partner relationships comparing baseline levels with those at 6 and 12 months from the usual care and intervention sites. These data will be collected by questionnaire. In addition, with the women's permission, medical records will be reviewed.


Condition or disease Intervention/treatment Phase
Postpartum Depression Behavioral: Screening and follow up Behavioral: Usual care Not Applicable

Detailed Description:

A randomized controlled trial of screening and management of postpartum depression that includes a second phase assessing the maintenance of the intervention in the original intervention sites and a switch from usual care to intervention in the control sites.

Planned enrollment includes 29 family medicine practices and 3000 women over a period of four years. All follow up and management is initiated within the family medicine practices to improve generalizability and likelihood for dissemination.

In addition to the patient centered outcomes, exploratory analyses will look at the uptake and degree of implementation and maintenance of the intervention based on characteristics of the practice including size, location, affiliation with larger group, type of practice and whether or not the practice is a community health center or residency practice.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Practice Based Clinical Trial of Screening, Diagnosis and Follow up Management for Postpartum Depression in Family Medicine Practices.
Study Start Date : September 2005
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Intervention arm
 Behavioral: Screening and follow up
Two stage screening with EPDS and PHQ-9, treatment for depression at physician's discretion and follow up phone calls and visits
Placebo Comparator: 2
Usual care
 Behavioral: Usual care
usual care for identification and management of postpartum depression


Outcome Measures
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Primary Outcome Measures :
  1. Level of depressive symptoms and level of parenting comfort [ Time Frame: 12 months postpartum ]

Secondary Outcome Measures :
  1. Percent eligible women screened and of those screen positive, percent treated and followed according to protocol [ Time Frame: 12 months for each women ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 5 to 12 weeks postpartum

  • Able to speak and read English or Spanish

    • 18 to 45 years of age

Exclusion Criteria:

  • Significant cognitive impairment and unable to answer screening questions
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00548743


Contacts
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Contact: Barbara P Yawn, MD MSc 507 287 2758 byawn@olmmed.org
Contact: Susan M Bertram, RN MSN 888 292 7164 sbertram@olmmed.org

Locations
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United States, Minnesota
Olmsted Medical Center Recruiting
Rochester, Minnesota, United States, 55904
Principal Investigator: Barbara P Yawn, MD MSc         
Sponsors and Collaborators
Olmsted Medical Center
Investigators
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Principal Investigator: Barbara P Yawn, MD MSc Olmsted Medical Center
More Information
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ClinicalTrials.gov Identifier: NCT00548743    
Other Study ID Numbers: 5R01HS014744-02 ( U.S. AHRQ Grant/Contract )
First Posted: October 24, 2007    Key Record Dates
Last Update Posted: December 4, 2007
Last Verified: October 2007
Keywords provided by Olmsted Medical Center:
Depression
Postpartum
Dyad satisfaction
Parenting comfort
Screening
 Management
Follow up
Primary care
Practice based research
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications