Postpartum DepressionNCT05225025
A Pilot Trial of the Reach Out, Stay Strong, Essentials for Mothers of Newborns (ROSE) Postpartum Depression Prevention Intervention in Pregnant Patients Admitted to Strong Hospital
A study testing ROSE in people with Postpartum Depression and Postpartum Anxiety, run by University of Rochester at 1 site in United States.
Trial summary
This study is a pilot, single-center, randomized controlled trial. It will 1. determine feasibility and acceptability of an evidence-based intervention for prevention of postpartum depression with antepartum patients on a high-risk obstetric unit, 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression, Postpartum Anxiety
- What is being tested?
- ROSE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2021to 2 May 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Viable pregnancy between 20 weeks 0 days and 35 weeks 0 days gestation at the time of enrollment
- Anticipated admission to the hospital for >5 days due to pregnancy complication requiring hospital observation
- Age > 18 years
- Planned hospitalization at Strong Memorial Hospital through the duration of antepartum course
- Planned delivery at Strong Memorial Hospital
Who cannot join
- Fetal demise in utero
- Inability to give informed consent secondary to intellectual capacity
- English is not primary language used to communicate
- Currently incarcerated
- Age < 18 years
- Planned antepartum hospitalization at another institution
- Planned delivery at another institution
- Actively suicidal or in need of acute psychiatric care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Trial of the ROSE Postpartum Depression Prevention Intervention in Antepartum Patients Admitted to High-risk Obstetrics Unit
This study is a pilot, single-center, randomized controlled trial. It will
- determine feasibility and acceptability of an evidence-based intervention for prevention of postpartum depression with antepartum patients on a high-risk obstetric unit,
- determine what adaptations may be needed for an inpatient population
- determine what retention strategies are most successful and acceptable for this patient population
- estimate the effect size of an intervention for in-hospital distress, anxiety and depression
- estimate the effect size of an intervention to reduce the risk of a post-partum depression diagnosis or depressive symptoms.
- Conditions
- Postpartum Depression, Postpartum Anxiety
- Being tested
- ROSE, Standard of Care
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSEBehavioural
The ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) program is an evidence-based intervention that has been proven to reduce cases of post-partum depression among low-income and racially and ethnically diverse women.
ROSE is administered to pregnant women in small group settings, typically in the same location that prenatal care is being provided (in this study, a hospital setting). It is divided into four 90-minute group sessions and teaches interpersonal psychotherapy-based skills that mitigate identified risk factors for PPD such as social support, stress management skills and communication.
ROSE curriculum will be implemented using groups in a continuous cycle, with patients entering into the intervention curriculum at the time of their enrollment and continuing through until all 4 total sessions have been accomplished.
Standard of CareOther
Usual hospital care with no behavioral intervention
| Study group | Role | What they receive |
|---|---|---|
| ROSE Intervention | Experimental | Not described Receives: Behavioral: ROSE |
| Standard of Care | Active comparator | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-reported in-hospital distress
Hospital distress will be measured using the Depression, Anxiety and Stress Scale-21 (DASS-21) Stress subscale. Stress subscale ranges from 0 to 42 with higher scores indicating worse outcome.
Measured: 14 days
Subject-reported depressive symptom severity
Depressive symptom severity will be measured using the Edinburgh Postnatal Depression Scale (EPDS). The scale ranges from 0-30 with higher scores indicating worse outcome.
Measured: 6 weeks postpartum
Subject-reported anxiety symptom severity
Anxiety symptom severity will be measured using the General Anxiety Disorder-7 (GAD-7) measurement scale. The scale ranges from 0 to 21 with higher scores indicating worse outcome.
Measured: 6 weeks postpartum
Clinical diagnosis of depression
Diagnosis of depression will be made using the Mini International Neuropsychiatric Interview (M.I.N.I) brief structured diagnostic interview which explores, in a standardized way, the main psychiatric disorders of Axis I of the DSM-IV TR. Only modules A and B (Major depressive episode and dysthymia) will be used. This structured interview contains questions with binary answers, with Yes indicating worse outcome.
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start5 Jul 2021
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Mae Stone Goode Foundation
- Responsible party
- Principal investigator, Ellen Poleshuck, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225025
- Sponsor's protocol ID
- STUDY00005941
- Status last verified
- Jun 2022
- First submitted
- 7 Jan 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toscano M, Rubano A, Santos SR, Hartman R, Marinescu PS, Zlotnick C, Poleshuck EL. Feasibility, Acceptability, and Exploratory Efficacy of Implementing an Intervention for Preventing Postpartum Depression in Antepartum Hospitalized Patients With High-Risk Pregnancy Complications: A Mixed-Methods Experimental Study. Womens Health Issues. 2026 May 28:S1049-3867(26)00069-1. doi: 10.1016/j.whi.2026.04.002. Online ahead of print.
PubMed 42209333
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of the ROSE Postpartum Depression Prevention Intervention in Antepartum Patients Admitted to High-risk Obstetrics Unit
- ClinicalTrials.gov ID
- NCT05225025
- Acronym / sponsor ID
- STUDY00005941
- Conditions
- Postpartum Depression, Postpartum Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Mae Stone Goode Foundation
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 4 Feb 2022 (actual)
- 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 study is a pilot, single-center, randomized controlled trial. It will
- determine feasibility and acceptability of an evidence-based intervention for prevention of postpartum depression with antepartum patients on a high-risk obstetric unit,
- determine what adaptations may be needed for an inpatient population
- determine what retention strategies are most successful and acceptable for this patient population
- estimate the effect size of an intervention for in-hospital distress, anxiety and depression
- estimate the effect size of an intervention to reduce the risk of a post-partum depression diagnosis or depressive symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROSE Intervention | Experimental | Behavioral: ROSE |
| Standard of Care | Active comparator | Other: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Viable pregnancy between 20 weeks 0 days and 35 weeks 0 days gestation at the time of enrollment
- Anticipated admission to the hospital for >5 days due to pregnancy complication requiring hospital observation
- Age > 18 years
- Planned hospitalization at Strong Memorial Hospital through the duration of antepartum course
- Planned delivery at Strong Memorial Hospital
Key exclusion criteria (8 listed)
- Fetal demise in utero
- Inability to give informed consent secondary to intellectual capacity
- English is not primary language used to communicate
- Currently incarcerated
- Age < 18 years
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 |
|---|---|---|
| ROSEThe ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) program is an evidence-based intervention that has been proven to reduce cases of post-partum depression among low-income and racially and ethnically diverse women. ROSE is administered to pregnant women in small group settings, typically in the same location that prenatal care is being provided (in this study, a hospital setting). It is divided into four 90-minute group sessions and teaches interpersonal psychotherapy-based skills that mitigate identified risk factors for PPD such as social support, stress management skills and communication. ROSE curriculum will be implemented using groups in a continuous cycle, with patients entering into the intervention curriculum at the time of their enrollment and continuing through until all 4 total sessions have been accomplished. | Behavioural | ROSE Intervention |
| Standard of CareUsual hospital care with no behavioral intervention | Other | Standard of Care |
Primary outcome
Subject-reported in-hospital distress
Time frame: 14 days
Hospital distress will be measured using the Depression, Anxiety and Stress Scale-21 (DASS-21) Stress subscale. Stress subscale ranges from 0 to 42 with higher scores indicating worse outcome.
Subject-reported depressive symptom severity
Time frame: 6 weeks postpartum
Depressive symptom severity will be measured using the Edinburgh Postnatal Depression Scale (EPDS). The scale ranges from 0-30 with higher scores indicating worse outcome.
Subject-reported anxiety symptom severity
Time frame: 6 weeks postpartum
Anxiety symptom severity will be measured using the General Anxiety Disorder-7 (GAD-7) measurement scale. The scale ranges from 0 to 21 with higher scores indicating worse outcome.
Clinical diagnosis of depression
Time frame: 6 weeks postpartum
Diagnosis of depression will be made using the Mini International Neuropsychiatric Interview (M.I.N.I) brief structured diagnostic interview which explores, in a standardized way, the main psychiatric disorders of Axis I of the DSM-IV TR. Only modules A and B (Major depressive episode and dysthymia) will be used. This structured interview contains questions with binary answers, with Yes indicating worse outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Derived from this study: PubMed 42209333Toscano M, Rubano A, Santos SR, Hartman R, Marinescu PS, Zlotnick C, Poleshuck EL. Feasibility, Acceptability, and Exploratory Efficacy of Implementing an Intervention for Preventing Postpartum Depression in Antepartum Hospitalized Patients With High-Risk Pregnancy Complications: A Mixed-Methods Experimental Study. Womens Health Issues. 2026 May 28:S1049-3867(26)00069-1. doi: 10.1016/j.whi.2026.04.002. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Postpartum Depression
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROSE in people with Postpartum Depression and Postpartum Anxiety, run by University of Rochester 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 13 Jun 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subject-reported in-hospital distress (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05225025, which also lists 1 linked publication.
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 13 Jun 2022.