Translating Research Into Practice for Postpartum Depression (TRIPPD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Olmsted Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Olmsted Medical Center
ClinicalTrials.gov Identifier:
NCT00548743
First received: October 22, 2007
Last updated: December 3, 2007
Last verified: October 2007
  Purpose

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 Intervention
Postpartum Depression
Behavioral: Screening and follow up
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Olmsted Medical Center:

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

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

Estimated Enrollment: 3000
Study Start Date: September 2005
Estimated Study Completion Date: August 2010
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548743

Contacts
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
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
Principal Investigator: Barbara P Yawn, MD MSc Olmsted Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00548743     History of Changes
Other Study ID Numbers: 5 R01 HS014744-02
Study First Received: October 22, 2007
Last Updated: December 3, 2007
Health Authority: United States: Institutional Review Board

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:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on August 20, 2014