Preventing Postpartum Depression in Prenatal Care

November 20, 2017 updated by: NYU Langone Health

Bellevue ROSE: Preventing Postpartum Depression in Prenatal Care

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • English speaking
  • Women who score between 5-19 on the PHQ-9 and >23 on the ANRQ

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Risk PTSD Group 1
Forty 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)
Behavioral: Bellevue ROSE Intervention
Behavioral: Psycho-education session and usual, Standard of care Control
Psycho Education and usual, standard of care
Active Comparator: High Risk PTSD Group 2
Forty 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)
Behavioral: Bellevue ROSE Intervention
Behavioral: Psycho-education session and usual, Standard of care Control
Psycho Education and usual, standard of care
Experimental: Low Risk PTSD Control
Twenty 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).
Behavioral: One Psycho-education session and usual, standard of care Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression severity measured by Patient Health Questionnaire (PHQ-9)
Time Frame: 6 Months
6 Months
Measure of psycho social risk assessment according to Adapted antenatal Risk Questionnaire (ANRQ)
Time Frame: Screening
Screening
Measure of perceived social support measured by Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: 6 Months
6 Months
Measure of stress using Perceived Stress Index (PSS)
Time Frame: 6 Months
6 Months
Parenting Practices and treatment assessed by Parenting Practices and Treatment Questionnaire
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Bonnie Kerker, MD, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

July 20, 2017

Study Completion (Actual)

July 20, 2017

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-01130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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