Translating Research Into Practice for Postpartum Depression (TRIPPD)
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|ClinicalTrials.gov Identifier: NCT00548743|
Recruitment Status : Unknown
Verified October 2007 by Olmsted Medical Center.
Recruitment status was: Recruiting
First Posted : October 24, 2007
Last Update Posted : December 4, 2007
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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.
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Depression||Behavioral: Screening and follow up Behavioral: Usual care||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Practice Based Clinical Trial of Screening, Diagnosis and Follow up Management for Postpartum Depression in Family Medicine Practices.|
|Study Start Date :||September 2005|
|Estimated Study Completion Date :||August 2010|
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
Behavioral: Usual care
usual care for identification and management of postpartum depression
- Level of depressive symptoms and level of parenting comfort [ Time Frame: 12 months postpartum ]
- Percent eligible women screened and of those screen positive, percent treated and followed according to protocol [ Time Frame: 12 months for each women ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 5 to 12 weeks postpartum
Able to speak and read English or Spanish
- 18 to 45 years of age
- Significant cognitive impairment and unable to answer screening questions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548743
|Contact: Barbara P Yawn, MD MSc||507 287 firstname.lastname@example.org|
|Contact: Susan M Bertram, RN MSN||888 292 email@example.com|
|United States, Minnesota|
|Olmsted Medical Center||Recruiting|
|Rochester, Minnesota, United States, 55904|
|Principal Investigator: Barbara P Yawn, MD MSc|
|Principal Investigator:||Barbara P Yawn, MD MSc||Olmsted Medical Center|
|Other Study ID Numbers:||
5R01HS014744-02 ( U.S. AHRQ Grant/Contract )
|First Posted:||October 24, 2007 Key Record Dates|
|Last Update Posted:||December 4, 2007|
|Last Verified:||October 2007|
Practice based research