TRIPPD: Translating Research Into Practice for Postpartum Depression

Sponsor

Olmsted Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00548743

Collaborator

(none)

3,000

Enrollment

Location

Arms

Duration (Months)

50.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Depression	Behavioral: Screening and follow up Behavioral: Usual care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

3000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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.

Study Start Date :

Sep 1, 2005

Anticipated Study Completion Date :

Aug 1, 2010

Arms and Interventions

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

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