Recruiting

Postpartum Depression

Sponsor:

Olmsted Medical Center

Code:

NCT00548743

Conditions

Postpartum Depression

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Screening and follow up

Usual care

Study Details

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.

Conditions

Postpartum Depression

Study ID

NCT00548743

Start date

Sep, 2005

Status verified date

Oct, 2007

Completion date

Aug, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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 Design

Enrollment

3000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 1

Intervention arm

placebo comparator: 2

Usual care

Interventions

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

Usual care

usual care for identification and management of postpartum depression

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Barbara P Yawn, MD MSc

507 287 2758byawn@olmmed.org

Susan M Bertram, RN MSN

888 292 7164sbertram@olmmed.org

Locations

Olmsted Medical Center

Recruiting

Rochester, Minnesota, United States, 55904

Principal Investigator:

Barbara P Yawn, MD MSc

More Information

Sponsor

Olmsted Medical Center

Last update posted

Dec 4, 2007

Last verified

Oct, 2007

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Olmsted Medical Center on 2007-12-04.