Translating Research Into Practice for Postpartum Depression (TRIPPD)

December 3, 2007 updated by: Olmsted Medical Center

Practice Based Clinical Trial of Screening, Diagnosis and Follow up Management for Postpartum Depression in Family Medicine Practices.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Barbara P Yawn, MD MSc
  • Phone Number: 507 287 2758
  • Email: byawn@olmmed.org

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55904
        • Recruiting
        • Olmsted Medical Center
        • Principal Investigator:
          • Barbara P Yawn, MD MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of depressive symptoms and level of parenting comfort
Time Frame: 12 months postpartum
12 months postpartum

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olmsted Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (Estimate)

October 24, 2007

Study Record Updates

Last Update Posted (Estimate)

December 4, 2007

Last Update Submitted That Met QC Criteria

December 3, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5R01HS014744-02 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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