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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Withdrawn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

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

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)

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

NCT ID

NCT02741206

First Posted

March 30, 2016

Last Updated

November 20, 2017

Sponsor

NYU Langone Health

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

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

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

Learn more about this trial

Preventing Postpartum Depression in Prenatal Care

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