Postpartum DepressionNCT05766475
In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression
A study testing ROSE Program: In Person and ROSE Program: Virtual in people with Postpartum Depression, run by University of Denver at 1 site in United States.
Trial summary
The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- ROSE Program: In Person and ROSE Program: Virtual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- English or Spanish speaking
- Less than 30 gestational weeks
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Denver Health Medical Center
Denver, Colorado, 80204
Jennifer Hyer, MD, Jennifer.Hyer@dhha.org
About this study
Official title: Group-based Prevention of Postpartum Depression: In-person vs. Virtual Delivery
The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.
Read the detailed description
Depression is one of the most common perinatal complications, with 1 in 7 mothers qualifying for a diagnosis of postpartum depression (PPD) and even higher rates for those who identify as Hispanic/Latine, Black or African American, American Indian, or Alaska Native, or by multiple races or ethnicities. This project addresses this major gap in services to prevent PPD, particularly among socioeconomically disadvantaged and minoritized groups. It tests the benefit of a virtual perinatal preventive intervention in English and Spanish to increase access, scalability and address the mental health needs of underserved populations. This project will test the virtual version against the in-person version of a service-ready efficacious preventive intervention in a randomized controlled trial (RCT). This trial will provide a test of a preventive intervention with a strong evidence base that is scalable and can be delivered with fidelity by service providers in settings where obstetric care is received. In this project, pregnant women will be randomized to receive an evidence-based group prevention program (Reach Out, Stay Strong, Essentials for New Moms; ROSE) designed for perinatal populations either a) in person, delivered at the hospital where they are receiving prenatal care or b) virtually, delivered by the same staff via video conferencing, both offered in English and Spanish. Diverse pregnant individuals (N = 900) will be randomized to receive virtual or in-person ROSE. The central outcome, depression, will be assessed via REDCap surveys, prenatally (before the program begins and at the end of gestation) and postpartum (approximately six-weeks, 3, 6, and 12-months after birth). Electronic health records (EHRs) and surveys will be used to examine obstetric, mental health (e.g., standard of care depression screening), and sociodemographic factors linked to health disparities that may impact who benefits most.
- Conditions
- Postpartum Depression
- Being tested
- ROSE Program: In Person, ROSE Program: Virtual
- Keywords
- Prenatal depression, health disparities, preventative intervention, virtual therapy, interpersonal therapy
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSE Program: In PersonBehavioural
Also called Rose, Group IPT, La Luz
In-person preventative intervention for postpartum depression that includes content on building social support and communication skills in relationships, navigating the role transition to motherhood, and learning about signs and symptoms of depression after delivery.
ROSE Program: VirtualBehavioural
Virtual ROSE covers the same content (e.g. improving social support and communication) and is delivered by the same facilitators as the in-person intervention via telehealth.
| Study group | Role | What they receive |
|---|---|---|
| In-Person Delivery of Group Preventative Intervention (ROSE) | Active comparator | The Reach Out, Stay Strong, Essentials for New Mothers Program (ROSE), is an established Interpersonal Therapy (IPT)-oriented group intervention for postpartum depression. ROSE is a brief (5-session) program and its content addresses social support, role transition to motherhood, communication skills, and psychoeducation on PPD. ROSE consists of four 90-minute, weekly in person group sessions and one individual booster session. The first four sessions of ROSE will be delivered in groups of 6 to 20, and conducted in both English and Spanish. For the in-person groups, transportation via Uber will be provided to Denver Health Medical Center to reduce barriers to attendance. Receives: Behavioral: ROSE Program: In Person |
| Virtual Delivery of Group Preventative Intervention (ROSE) | Experimental | In parallel to ROSE delivered in person, virtual ROSE consists of four 90-minute, weekly group sessions conducted via Zoom and one individual booster session. Receives: Behavioral: ROSE Program: Virtual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Checklist 20 (SCL 20)
Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.
Measured: 6 weeks after birth
Symptom Checklist 20 (SCL 20)
Self reported depression scores.Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.
Measured: 3 months after birth
Symptom Checklist 20 (SCL 20)
Self reported depression scores
Measured: 6 months after birth
Symptom Checklist 20 (SCL 20)
Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.
Measured: 12 months after birth
Center for Epidemiologic Studies Depression Scale (CES-D)
Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.
Measured: 6 weeks after birth
Center for Epidemiologic Studies Depression Scale (CES-D)
Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.
Measured: 3 months after birth
Center for Epidemiologic Studies Depression Scale (CES-D)
Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.
Measured: 6 months after birth
Center for Epidemiologic Studies Depression Scale (CES-D)
Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.
Measured: 12 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start13 Mar 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
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.
- 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Denver Health Medical Center
- Responsible party
- Sponsor
- Investigators
- Galena Rhoades, PhD, Principal investigator, University of DenverElysia P Davis, PhD, Principal investigator, University of Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766475
- Sponsor's protocol ID
- 1916994-3
- Other IDs
- R01MH130976-01
- Status last verified
- May 2023
- First submitted
- 1 Mar 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared in accordance with NIMH Data Archive requirements.
Publications
Liu DY, Perry NS, Demers CH, Hyer JS, Alamo A, Vuksanovich P, Dube N, Flanagan ER, Gallop RJ, Rhoades GK, Davis EP. Virtual versus in-person ROSE program (La Luz) as universal prevention for perinatal depression: Protocol for a randomized controlled trial in a safety net hospital. Contemp Clin Trials. 2025 Aug;155:107988. doi: 10.1016/j.cct.2025.107988. Epub 2025 Jun 15.
PubMed 40527396
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group-based Prevention of Postpartum Depression: In-person vs. Virtual Delivery
- ClinicalTrials.gov ID
- NCT05766475
- Acronym / sponsor ID
- 1916994-3
- Conditions
- Postpartum Depression
- Keywords
- Prenatal depression, health disparities, preventative intervention, virtual therapy, interpersonal therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of DenverUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Denver Health Medical Center
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Mar 2023 (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.
The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.
Detailed description
Depression is one of the most common perinatal complications, with 1 in 7 mothers qualifying for a diagnosis of postpartum depression (PPD) and even higher rates for those who identify as Hispanic/Latine, Black or African American, American Indian, or Alaska Native, or by multiple races or ethnicities. This project addresses this major gap in services to prevent PPD, particularly among socioeconomically disadvantaged and minoritized groups. It tests the benefit of a virtual perinatal preventive intervention in English and Spanish to increase access, scalability and address the mental health needs of underserved populations. This project will test the virtual version against the in-person version of a service-ready efficacious preventive intervention in a randomized controlled trial (RCT). This trial will provide a test of a preventive intervention with a strong evidence base that is scalable and can be delivered with fidelity by service providers in settings where obstetric care is received. In this project, pregnant women will be randomized to receive an evidence-based group prevention program (Reach Out, Stay Strong, Essentials for New Moms; ROSE) designed for perinatal populations either a) in person, delivered at the hospital where they are receiving prenatal care or b) virtually, delivered by the same staff via video conferencing, both offered in English and Spanish. Diverse pregnant individuals (N = 900) will be randomized to receive virtual or in-person ROSE. The central outcome, depression, will be assessed via REDCap surveys, prenatally (before the program begins and at the end of gestation) and postpartum (approximately six-weeks, 3, 6, and 12-months after birth). Electronic health records (EHRs) and surveys will be used to examine obstetric, mental health (e.g., standard of care depression screening), and sociodemographic factors linked to health disparities that may impact who benefits most.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person Delivery of Group Preventative Intervention (ROSE) | Active comparator | Behavioral: ROSE Program: In PersonThe Reach Out, Stay Strong, Essentials for New Mothers Program (ROSE), is an established Interpersonal Therapy (IPT)-oriented group intervention for postpartum depression. ROSE is a brief (5-session) program and its content addresses social support, role transition to motherhood, communication skills, and psychoeducation on PPD. ROSE consists of four 90-minute, weekly in person group sessions and one individual booster session. The first four sessions of ROSE will be delivered in groups of 6 to 20, and conducted in both English and Spanish. For the in-person groups, transportation via Uber will be provided to Denver Health Medical Center to reduce barriers to attendance. |
| Virtual Delivery of Group Preventative Intervention (ROSE) | Experimental | Behavioral: ROSE Program: VirtualIn parallel to ROSE delivered in person, virtual ROSE consists of four 90-minute, weekly group sessions conducted via Zoom and one individual booster session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English or Spanish speaking
- Less than 30 gestational weeks
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ROSE Program: In PersonAlso: Rose, Group IPT, La LuzIn-person preventative intervention for postpartum depression that includes content on building social support and communication skills in relationships, navigating the role transition to motherhood, and learning about signs and symptoms of depression after delivery. | Behavioural | In-Person Delivery of Group Preventative Intervention (ROSE) |
| ROSE Program: VirtualVirtual ROSE covers the same content (e.g. improving social support and communication) and is delivered by the same facilitators as the in-person intervention via telehealth. | Behavioural | Virtual Delivery of Group Preventative Intervention (ROSE) |
Primary outcome
Symptom Checklist 20 (SCL 20)
Time frame: 6 weeks after birth
Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.
Symptom Checklist 20 (SCL 20)
Time frame: 3 months after birth
Self reported depression scores.Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.
Symptom Checklist 20 (SCL 20)
Time frame: 6 months after birth
Self reported depression scores
Symptom Checklist 20 (SCL 20)
Time frame: 12 months after birth
Self reported depression scores. Possible range of scores is 0 to 80, with the higher scores indicating higher depression levels.
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 6 weeks after birth
Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 3 months after birth
Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 6 months after birth
Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 12 months after birth
Self reported depression scores. Possible range of scores is 0 to 60, with the higher scores indicating higher depression levels.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 40527396Liu DY, Perry NS, Demers CH, Hyer JS, Alamo A, Vuksanovich P, Dube N, Flanagan ER, Gallop RJ, Rhoades GK, Davis EP. Virtual versus in-person ROSE program (La Luz) as universal prevention for perinatal depression: Protocol for a randomized controlled trial in a safety net hospital. Contemp Clin Trials. 2025 Aug;155:107988. doi: 10.1016/j.cct.2025.107988. Epub 2025 Jun 15.
- Individual participant dataSharing planned: Yes. All data will be shared in accordance with NIMH Data Archive requirements.
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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.
Galena Rhoades, PhD principal investigator
University of Denver
Elysia P Davis, PhD principal investigator
University of Denver
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 Program: In Person and ROSE Program: Virtual in people with Postpartum Depression, run by University of Denver 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 1 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: looking for participants now, as of the sponsor's last update on 17 May 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Galena Rhoades, PhD (303-871-4280, Galena.Rhoades@du.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Checklist 20 (SCL 20) (time frame: 6 weeks after birth). The study lists 8 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 NCT05766475, 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 17 May 2023.