Translating Research Into Practice for Postpartum Depression - Full Text View

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

MedlinePlus related topics:

Depression Parenting Postpartum Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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

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
1: Experimental 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
2: Placebo Comparator 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

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

Describes study for sites not for patients This link exits the ClinicalTrials.gov site

Study ID Numbers:	5 R01 HS014744-02
First Received:	October 22, 2007
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00548743
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

Study placed in the following topic categories:

Pregnancy Complications

Depression

Puerperal Disorders

Depression, Postpartum

Mental Disorders

Mood Disorders

Depressive Disorder

Behavioral Symptoms

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Olmsted Medical Center
Information provided by:	Olmsted Medical Center
ClinicalTrials.gov Identifier:	NCT00548743