Post-partum DepressionNCT02741206
Preventing Postpartum Depression in Prenatal Care
A study testing Bellevue ROSE Intervention in people with Post-partum Depression, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post-partum Depression
- What is being tested?
- Bellevue ROSE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 20 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- English speaking
- Women who score between 5-19 on the PHQ-9 and >23 on the ANRQ
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Bellevue ROSE: Preventing Postpartum Depression in Prenatal Care
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
- Conditions
- Post-partum Depression
- Being tested
- Bellevue ROSE Intervention, Psycho-education session and usual, Standard of care Control, One Psycho-education session and usual, standard of care Control
- Keywords
- psycho-education, maternal depression, Reach Out Stay Strong Essentials
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bellevue ROSE InterventionBehavioural
Psycho-education session and usual, Standard of care ControlBehavioural
Psycho Education and usual, standard of care
One Psycho-education session and usual, standard of care ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| High Risk PTSD Group 1 | Active comparator | 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) Receives: Behavioral: Bellevue ROSE Intervention; Behavioral: Psycho-education session and usual, Standard of care Control |
| High Risk PTSD Group 2 | Active comparator | 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) Receives: Behavioral: Bellevue ROSE Intervention; Behavioral: Psycho-education session and usual, Standard of care Control |
| Low Risk PTSD Control | Experimental | 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). Receives: Behavioral: One Psycho-education session and usual, standard of care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity measured by Patient Health Questionnaire (PHQ-9)
Measured: 6 Months
Measure of psycho social risk assessment according to Adapted antenatal Risk Questionnaire (ANRQ)
Measured: Screening
Measure of perceived social support measured by Multidimensional Scale of Perceived Social Support (MSPSS)
Measured: 6 Months
Measure of stress using Perceived Stress Index (PSS)
Measured: 6 Months
Parenting Practices and treatment assessed by Parenting Practices and Treatment Questionnaire
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJun 2016
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-partum DepressionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bonnie Kerker, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741206
- Sponsor's protocol ID
- 15-01130
- Status last verified
- Nov 2017
- First submitted
- 30 Mar 2016
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bellevue ROSE: Preventing Postpartum Depression in Prenatal Care
- ClinicalTrials.gov ID
- NCT02741206
- Acronym / sponsor ID
- 15-01130
- Conditions
- Post-partum Depression
- Keywords
- psycho-education, maternal depression, Reach Out Stay Strong Essentials
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Risk PTSD Group 1 | Active comparator | Behavioral: Bellevue ROSE Intervention, Behavioral: Psycho-education session and usual, Standard of care ControlForty 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) |
| High Risk PTSD Group 2 | Active comparator | Behavioral: Bellevue ROSE Intervention, Behavioral: Psycho-education session and usual, Standard of care ControlForty 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) |
| Low Risk PTSD Control | Experimental | Behavioral: One Psycho-education session and usual, standard of care ControlTwenty 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- English speaking
- Women who score between 5-19 on the PHQ-9 and >23 on the ANRQ
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bellevue ROSE Intervention | Behavioural | High Risk PTSD Group 1, High Risk PTSD Group 2 |
| Psycho-education session and usual, Standard of care ControlPsycho Education and usual, standard of care | Behavioural | High Risk PTSD Group 1, High Risk PTSD Group 2 |
| One Psycho-education session and usual, standard of care Control | Behavioural | Low Risk PTSD Control |
Primary outcome
Depression severity measured by Patient Health Questionnaire (PHQ-9)
Time frame: 6 Months
Measure of psycho social risk assessment according to Adapted antenatal Risk Questionnaire (ANRQ)
Time frame: Screening
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Kerker, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bellevue ROSE Intervention in people with Post-partum Depression, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression severity measured by Patient Health Questionnaire (PHQ-9) (time frame: 6 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.