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Translating Research Into Practice for Postpartum Depression

NCT ID: NCT00548743

Last Updated: 2007-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postpartum Depression

Keywords

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Depression Postpartum Dyad satisfaction Parenting comfort Screening Management Follow up Primary care Practice based research

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Intervention arm

Group Type EXPERIMENTAL

Screening and follow up

Intervention Type BEHAVIORAL

Two stage screening with EPDS and PHQ-9, treatment for depression at physician's discretion and follow up phone calls and visits

2

Usual care

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

usual care for identification and management of postpartum depression

Interventions

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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

Intervention Type BEHAVIORAL

Usual care

usual care for identification and management of postpartum depression

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Olmsted Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Barbara P Yawn, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Olmsted Medical Center

Locations

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Olmsted Medical Center

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Barbara P Yawn, MD MSc

Role: CONTACT

Phone: 507 287 2758

Email: [email protected]

Susan M Bertram, RN MSN

Role: CONTACT

Phone: 888 292 7164

Email: [email protected]

Other Identifiers

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5R01HS014744-02

Identifier Type: AHRQ

Identifier Source: org_study_id

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