Preventing Postpartum Depression in Prenatal Care
Bellevue ROSE: Preventing Postpartum Depression in Prenatal Care
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This is randomized control trial of a brief intervention called Bellevue ROSE (Reach Out Stay Strong Essentials). Bellevue ROSE is a manualized and highly structured interpersonal intervention that provides women with psycho-education about maternal depression and strategies for strengthening social support and connectedness. Investigators use motivational interviewing strategies to improve treatment compliance and resource acquisition
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2016
CompletedFirst Posted
Study publicly available on registry
April 18, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2017
CompletedNovember 22, 2017
November 1, 2017
1.1 years
March 30, 2016
November 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Depression severity measured by Patient Health Questionnaire (PHQ-9)
6 Months
Measure of psycho social risk assessment according to Adapted antenatal Risk Questionnaire (ANRQ)
Screening
Measure of perceived social support measured by Multidimensional Scale of Perceived Social Support (MSPSS)
6 Months
Measure of stress using Perceived Stress Index (PSS)
6 Months
Parenting Practices and treatment assessed by Parenting Practices and Treatment Questionnaire
6 Months
Study Arms (3)
High Risk PTSD Group 1
ACTIVE COMPARATORForty women who are eligible for the study will be randomized into either the Bellevue ROSE intervention (treatment group) or a psycho-education session and usual, standard of care (control group 1)
High Risk PTSD Group 2
ACTIVE COMPARATORForty women who are eligible for the study will be randomized into either the Bellevue ROSE intervention (treatment group) or a psycho-education session and usual, standard of care (control group 1)
Low Risk PTSD Control
EXPERIMENTALTwenty additional women, who are at lower risk and thus not eligible for randomization, will also receive one psycho-education session and usual care (control group 2).
Interventions
Psycho Education and usual, standard of care
Eligibility Criteria
You may qualify if:
- English speaking
- Women who score between 5-19 on the PHQ-9 and \>23 on the ANRQ
You may not qualify if:
- Women who score \<5 or \>19 on the PHQ-9
- Women who are currently suicidal, active substance users, currently experiencing domestic violence, or have a current or past history of bipolar or psychotic disorder diagnosis.
- Women who are currently in treatment for psychotherapy.
- Unable to speak and/or understand English proficiently
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bonnie Kerker, MD
New York University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2016
First Posted
April 18, 2016
Study Start
June 1, 2016
Primary Completion
July 20, 2017
Study Completion
July 20, 2017
Last Updated
November 22, 2017
Record last verified: 2017-11