Preventing Postpartum Depression in Prenatal Care

Post-partum Depression Clinical Trial

Official title:

Bellevue ROSE: Preventing Postpartum Depression in Prenatal Care

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02741206
• Other study ID #: 15-01130
• Status: Withdrawn
• Phase: N/A
• First received: March 30, 2016
• Last updated: November 20, 2017
• Start date: June 2016
• Est. completion date: July 20, 2017

Study information

• Verified date: November 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 20, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post-partum Depression

Intervention

Behavioral:
• Bellevue ROSE Intervention

• Psycho-education session and usual, Standard of care Control
Psycho Education and usual, standard of care
• One Psycho-education session and usual, standard of care Control

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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