Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-06-30
2017-07-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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)
Bellevue ROSE Intervention
Psycho-education session and usual, Standard of care Control
Psycho Education and usual, standard of care
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)
Bellevue ROSE Intervention
Psycho-education session and usual, Standard of care Control
Psycho Education and usual, standard of care
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).
One Psycho-education session and usual, standard of care Control
Interventions
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Bellevue ROSE Intervention
Psycho-education session and usual, Standard of care Control
Psycho Education and usual, standard of care
One Psycho-education session and usual, standard of care Control
Eligibility Criteria
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Inclusion Criteria
* Women who score between 5-19 on the PHQ-9 and \>23 on the ANRQ
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Bonnie Kerker, MD
Role: PRINCIPAL_INVESTIGATOR
New York University Medical School
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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15-01130
Identifier Type: -
Identifier Source: org_study_id