Preventing Postpartum Depression in Prenatal Care

NYU Langone Health

Status: Withdrawn

Conditions: Post-partum Depression

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT02741206

15-01130

Details and patient eligibility

About

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

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 3 patient groups

High Risk PTSD Group 1

Active Comparator group

Description:

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)

Treatment:

Behavioral: Psycho-education session and usual, Standard of care Control

Behavioral: Bellevue ROSE Intervention

High Risk PTSD Group 2

Active Comparator group

Description:

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)

Treatment:

Behavioral: Psycho-education session and usual, Standard of care Control

Behavioral: Bellevue ROSE Intervention

Low Risk PTSD Control

Experimental group

Description:

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).

Treatment:

Behavioral: One Psycho-education session and usual, standard of care Control