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Preventing Postpartum Depression in Prenatal Care

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ClinicalTrials.gov Identifier: NCT02741206
Recruitment Status : Withdrawn
First Posted : April 18, 2016
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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

Condition or disease Intervention/treatment Phase
Post-partum Depression Behavioral: Bellevue ROSE Intervention Behavioral: Psycho-education session and usual, Standard of care Control Behavioral: One Psycho-education session and usual, standard of care Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Bellevue ROSE: Preventing Postpartum Depression in Prenatal Care
Study Start Date : June 2016
Actual Primary Completion Date : July 20, 2017
Actual Study Completion Date : July 20, 2017

Resource links provided by the National Library of Medicine


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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741206


Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Bonnie Kerker, MD New York University Medical School

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02741206     History of Changes
Other Study ID Numbers: 15-01130
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Keywords provided by New York University School of Medicine:
psycho-education
maternal depression
Reach Out Stay Strong Essentials

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications