Preventing Postpartum Depression in Prenatal Care

Study Overview
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Brief Summary
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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

Official Title
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Bellevue ROSE: Preventing Postpartum Depression in Prenatal Care

Conditions
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Post-partum Depression

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Risk PTSD Group 1<br>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<br> <br> Behavioral: Psycho-education session and usual, Standard of care Control<br>* Psycho Education and usual, standard of care<br>|
| Active Comparator: High Risk PTSD Group 2<br>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<br> <br> Behavioral: Psycho-education session and usual, Standard of care Control<br>* Psycho Education and usual, standard of care<br>|
| Experimental: Low Risk PTSD Control<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psycho-education, maternal depression, Reach Out Stay Strong Essentials