Postpartum DepressionTRIPPDNCT00548743
Translating Research Into Practice for Postpartum Depression
A study testing Screening and follow up in people with Postpartum Depression, run by Olmsted Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Screening and follow up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 5 to 12 weeks postpartum
- Able to speak and read English or Spanish
- 18 to 45 years of age
Who cannot join
- Significant cognitive impairment and unable to answer screening questions
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Olmsted Medical Center
Rochester, Minnesota, 55904
Barbara P Yawn, MD MSc
About this study
Official title: Practice Based Clinical Trial of Screening, Diagnosis and Follow up Management for Postpartum Depression in Family Medicine Practices.
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.
Read the 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.
- Conditions
- Postpartum Depression
- Being tested
- Screening and follow up, Usual care
- Keywords
- Depression, Postpartum, Dyad satisfaction, Parenting comfort, Screening, Management, Follow up, Primary care, Practice based research
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and follow upBehavioural
Two stage screening with EPDS and PHQ-9, treatment for depression at physician's discretion and follow up phone calls and visits
Usual careBehavioural
usual care for identification and management of postpartum depression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention arm Receives: Behavioral: Screening and follow up |
| 2 | Placebo comparator | Usual care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of depressive symptoms and level of parenting comfort
Measured: 12 months postpartum
Secondary outcomes (1)
Percent eligible women screened and of those screen positive, percent treated and followed according to protocol
Measured: 12 months for each women
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study startSep 2005
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olmsted Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Barbara P Yawn, MD MSc, Principal investigator, Olmsted Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548743
- Sponsor's protocol ID
- 5R01HS014744-02
- Acronym
- TRIPPD
- Status last verified
- Oct 2007
- First submitted
- 22 Oct 2007
- Last updated
- 4 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice Based Clinical Trial of Screening, Diagnosis and Follow up Management for Postpartum Depression in Family Medicine Practices.
- ClinicalTrials.gov ID
- NCT00548743
- Acronym / sponsor ID
- TRIPPD / 5R01HS014744-02
- Conditions
- Postpartum Depression
- Keywords
- Depression, Postpartum, Dyad satisfaction, Parenting comfort, Screening, Management, Follow up, Primary care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Olmsted Medical CenterUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Aug 2010 (estimated)
- First posted
- 24 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Screening and follow upIntervention arm |
| 2 | Placebo comparator | Behavioral: Usual careUsual care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 5 to 12 weeks postpartum
- Able to speak and read English or Spanish
Key exclusion criteria (1 listed)
- Significant cognitive impairment and unable to answer screening questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening and follow upTwo stage screening with EPDS and PHQ-9, treatment for depression at physician's discretion and follow up phone calls and visits | Behavioural | 1 |
| Usual careusual care for identification and management of postpartum depression | Behavioural | 2 |
Primary outcome
Level of depressive symptoms and level of parenting comfort
Time frame: 12 months postpartum
1 secondary outcome
Percent eligible women screened and of those screen positive, percent treated and followed according to protocol
Time frame: 12 months for each women
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara P Yawn, MD MSc principal investigator
Olmsted Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening and follow up in people with Postpartum Depression, run by Olmsted Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara P Yawn, MD MSc (507 287 2758, byawn@olmmed.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of depressive symptoms and level of parenting comfort (time frame: 12 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2007.