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Behavioral Intervention
In-Person vs. Virtual Therapy for Postpartum Depression
N/A
Recruiting
Led By Elysia P Davis, PhD
Research Sponsored by University of Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after birth
Awards & highlights
Study Summary
This trial tests if online therapy can prevent postpartum depression like in-person therapy.
Who is the study for?
This trial is for English or Spanish-speaking individuals who are less than 30 weeks into their pregnancy. It's designed to help prevent postpartum depression and there are no specific exclusion criteria, meaning it's quite open for participants.Check my eligibility
What is being tested?
The study is comparing the effectiveness of a group therapy program called ROSE in preventing postpartum depression when delivered in two ways: face-to-face (in person) and over the internet (virtually).See study design
What are the potential side effects?
Since this trial involves a psychological therapy program rather than medication, traditional side effects like those seen with drugs aren't expected. Participants may experience emotional discomfort discussing personal issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after birth
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after birth
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Center for Epidemiologic Studies Depression Scale (CES-D)
Symptom Checklist 20 (SCL 20)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Delivery of Group Preventative Intervention (ROSE)Experimental Treatment1 Intervention
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.
Group II: In-Person Delivery of Group Preventative Intervention (ROSE)Active Control1 Intervention
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.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,794 Previous Clinical Trials
2,692,990 Total Patients Enrolled
24 Trials studying Postpartum Depression
7,243 Patients Enrolled for Postpartum Depression
University of DenverLead Sponsor
23 Previous Clinical Trials
9,341 Total Patients Enrolled
Denver Health Medical CenterOTHER
12 Previous Clinical Trials
4,699 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak English or Spanish.Not applicable.
Research Study Groups:
This trial has the following groups:- Group 1: In-Person Delivery of Group Preventative Intervention (ROSE)
- Group 2: Virtual Delivery of Group Preventative Intervention (ROSE)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still available slots for participants in this clinical trial?
"Confirmed, this clinical trial is continuing to accept new participants. Initially published on March 1st 2023 and most recently amended on the same date, its information can be found hosted on clinicaltrials.gov."
Answered by AI
What is the quota for participants in this investigation?
"Affirmative. Clinicaltrials.gov verifies that this experiment, initially posted on March 1st 2023, is accepting new patients as of now. It requires approximately 900 individuals to join from a single clinical site."
Answered by AI
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