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Translating Research Into Practice for Postpartum Depression (TRIPPD)

Primary Purpose

Postpartum Depression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening and follow up
Usual care
Sponsored by
Olmsted Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Postpartum Depression focused on measuring Depression, Postpartum, Dyad satisfaction, Parenting comfort, Screening, Management, Follow up, Primary care, Practice based research

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Olmsted Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Intervention arm

Usual care

Outcomes

Primary Outcome Measures

Level of depressive symptoms and level of parenting comfort

Secondary Outcome Measures

Percent eligible women screened and of those screen positive, percent treated and followed according to protocol

Full Information

First Posted
October 22, 2007
Last Updated
December 3, 2007
Sponsor
Olmsted Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00548743
Brief Title
Translating Research Into Practice for Postpartum Depression
Acronym
TRIPPD
Official Title
Practice Based Clinical Trial of Screening, Diagnosis and Follow up Management for Postpartum Depression in Family Medicine Practices.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Olmsted Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Depression, Postpartum, Dyad satisfaction, Parenting comfort, Screening, Management, Follow up, Primary care, Practice based research

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Intervention arm
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Screening and follow up
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
usual care for identification and management of postpartum depression
Primary Outcome Measure Information:
Title
Level of depressive symptoms and level of parenting comfort
Time Frame
12 months postpartum
Secondary Outcome Measure Information:
Title
Percent eligible women screened and of those screen positive, percent treated and followed according to protocol
Time Frame
12 months for each women

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara P Yawn, MD MSc
Phone
507 287 2758
Email
byawn@olmmed.org
First Name & Middle Initial & Last Name or Official Title & Degree
Susan M Bertram, RN MSN
Phone
888 292 7164
Email
sbertram@olmmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara P Yawn, MD MSc
Organizational Affiliation
Olmsted Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Olmsted Medical Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara P Yawn, MD MSc

12. IPD Sharing Statement

Learn more about this trial

Translating Research Into Practice for Postpartum Depression

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