Clinical trial NCT00548743: Translating Research Into Practice for Postpartum Depression
Official title: Practice Based Clinical Trial of Screening, Diagnosis and Follow up Management for Postpartum Depression in Family Medicine Practices.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Depression
Keywords: Depression
Postpartum
Dyad satisfaction
Parenting comfort
Screening
Management
Follow up
Primary care
Practice based research
Lead sponsor: Olmsted Medical Center
Sponsor class: OTHER
First posted: 2007-10-24
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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 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

Primary outcomes:
measure: Level of depressive symptoms and level of parenting comfort
timeFrame: 12 months postpartum
Secondary outcomes:
measure: Percent eligible women screened and of those screen positive, percent treated and followed according to protocol
timeFrame: 12 months for each women
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Olmsted Medical Center
state: Minnesota
Study officials:
affiliation: Olmsted Medical Center
name: Barbara P Yawn, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: