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Preventing Postpartum Depression in Prenatal Care

Primary Purpose

Post-partum Depression

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bellevue ROSE Intervention
Psycho-education session and usual, Standard of care Control
One Psycho-education session and usual, standard of care Control
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-partum Depression focused on measuring psycho-education, maternal depression, Reach Out Stay Strong Essentials

Eligibility Criteria

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

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

High Risk PTSD Group 1

High Risk PTSD Group 2

Low Risk PTSD Control

Arm Description

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)

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)

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 30, 2016
Last Updated
November 20, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02741206
Brief Title
Preventing Postpartum Depression in Prenatal Care
Official Title
Bellevue ROSE: Preventing Postpartum Depression in Prenatal Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Study Start Date
June 2016 (undefined)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-partum Depression
Keywords
psycho-education, maternal depression, Reach Out Stay Strong Essentials

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Risk PTSD Group 1
Arm Type
Active Comparator
Arm Description
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)
Arm Title
High Risk PTSD Group 2
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Low Risk PTSD Control
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Bellevue ROSE Intervention
Intervention Type
Behavioral
Intervention Name(s)
Psycho-education session and usual, Standard of care Control
Intervention Description
Psycho Education and usual, standard of care
Intervention Type
Behavioral
Intervention Name(s)
One Psycho-education session and usual, standard of care Control
Primary Outcome Measure Information:
Title
Depression severity measured by Patient Health Questionnaire (PHQ-9)
Time Frame
6 Months
Title
Measure of psycho social risk assessment according to Adapted antenatal Risk Questionnaire (ANRQ)
Time Frame
Screening
Title
Measure of perceived social support measured by Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame
6 Months
Title
Measure of stress using Perceived Stress Index (PSS)
Time Frame
6 Months
Title
Parenting Practices and treatment assessed by Parenting Practices and Treatment Questionnaire
Time Frame
6 Months

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie Kerker, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Preventing Postpartum Depression in Prenatal Care

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