Translating Research Into Practice for Postpartum Depression

Study Overview
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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.

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

Conditions
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Postpartum Depression

Intervention / Treatment
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* Behavioral: Screening and follow up
* Behavioral: Usual care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intervention arm | Behavioral: Screening and follow up<br>* Two stage screening with EPDS and PHQ-9, treatment for depression at physician's discretion and follow up phone calls and visits<br>|
| Placebo Comparator: 2<br>Usual care | Behavioral: Usual care<br>* usual care for identification and management of postpartum depression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of depressive symptoms and level of parenting comfort |  | 12 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent eligible women screened and of those screen positive, percent treated and followed according to protocol |  | 12 months for each women | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Postpartum, Dyad satisfaction, Parenting comfort, Screening, Management, Follow up, Primary care, Practice based research