Preventing Postpartum Depression in Prenatal Care

Not Applicable

Withdrawn

• Conditions: Post-partum Depression
• Interventions: Behavioral: Bellevue ROSE Intervention; Behavioral: One Psycho-education session and usual, standard of care Control; Behavioral: Psycho-education session and usual, Standard of care Control

• Registration Number: NCT02741206
• Lead Sponsor: NYU Langone Health

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-18
• Study Start: 2016-06
• Primary Completion: 2017-07-20
• Study Completion: 2017-07-20
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Risk PTSD Group 2	Psycho-education session and usual, Standard of care Control	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)
High Risk PTSD Group 1	Psycho-education session and usual, Standard of care Control	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)
High Risk PTSD Group 2	Bellevue ROSE Intervention	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)
Low Risk PTSD Control	One Psycho-education session and usual, standard of care 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).
High Risk PTSD Group 1	Bellevue ROSE Intervention	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)

Primary Outcome Measures

Name	Time	Method
Depression severity measured by Patient Health Questionnaire (PHQ-9)	6 Months
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
Measure of psycho social risk assessment according to Adapted antenatal Risk Questionnaire (ANRQ)	Screening

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States