NCT05766475 · University of Denver
In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
ROSE Program: In Person
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.
BEHAVIORAL
ROSE Program: Virtual
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- English or Spanish speaking
- Less than 30 gestational weeks
Where
- Denver, Colorado
Collaborators
National Institute of Mental Health (NIMH), Denver Health Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 17, 2023 · Source of record for eligibility and locations