Bellevue ROSE: Preventing Postpartum Depression in Prenatal Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- NYU Langone Health
- Locations
- 1
- Primary Endpoint
- Depression severity measured by Patient Health Questionnaire (PHQ-9)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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)
Intervention: Bellevue ROSE Intervention (Behavioral)
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)
Intervention: Psycho-education session and usual, Standard of care Control (Behavioral)
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)
Intervention: Bellevue ROSE Intervention (Behavioral)
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)
Intervention: Psycho-education session and usual, Standard of care Control (Behavioral)
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).
Intervention: One Psycho-education session and usual, standard of care Control (Behavioral)
Outcomes
Primary Outcomes
Depression severity measured by Patient Health Questionnaire (PHQ-9)
Time Frame: 6 Months
Measure of perceived social support measured by Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: 6 Months
Measure of stress using Perceived Stress Index (PSS)
Time Frame: 6 Months
Parenting Practices and treatment assessed by Parenting Practices and Treatment Questionnaire
Time Frame: 6 Months
Measure of psycho social risk assessment according to Adapted antenatal Risk Questionnaire (ANRQ)
Time Frame: Screening
Secondary Outcomes
No secondary outcomes reported