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RISE Program for Pregnancy-Related Depression and Anxiety (RISE Trial)
Phase 2 & 3
Recruiting
Research Sponsored by Cedars-Sinai Medical Center
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 6 months - 1 year
Awards & highlights
RISE Trial Summary
This trial will investigate how reducing inflammation can help reduce the risk of Perinatal Mood and Anxiety Disorders, which affect 13% of pregnant women, especially Black women. The intervention involves building communication & self-advocacy skills to reduce stress & improve outcomes.
Who is the study for?
This trial is for English-speaking Black pregnant women at least 18 years old in the US, who have access to a tablet, smartphone, or computer and are willing to follow study procedures. It's not for those with psychosis or perinatal loss.Check my eligibility
What is being tested?
The RISE program aims to reduce stress and improve mental health in Black pregnant women by using mobile Health (mHealth) interventions like MWSH and Candlelit Care. The study will test if these can lower depression/anxiety rates and inflammation.See study design
What are the potential side effects?
Since this trial involves non-medical interventions focused on support and education through mHealth platforms, there may be minimal side effects such as increased screen time potentially leading to eye strain or headache.
RISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months - 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months - 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety symptoms
Mental Depression
PTSD Symptoms
Secondary outcome measures
Communication
Discrimination stress
Self-Advocacy
Other outcome measures
Inflammation
RISE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MWSH plus Candlelit CareExperimental Treatment1 Intervention
Candlelit Care is a virtual perinatal mental health application that builds on cognitive behavioral therapy (CBT) to provide Black, Indigenous and POC women and birthing parents access to culturally affirming mental health support during pregnancy. Driven by an integrated care team, women have access to self-guided therapeutic tools, peer coaching and education about perinatal mood disorders as a primary resource. This convenient and trauma informed app allows parents to see if their mental health symptoms warrant further treatment in a secure setting. The app also provides education of role transitions, discussion of types of interpersonal conflicts common around childbirth (including racial discrimination) and techniques for resolving them, and role-playing with feedback from other parents during groups. The goals are to improve self-advocacy skills; patient communication with medical providers and provide a support network with other Black pregnant women.
Group II: Maternal Wellness Self Help (MWSH) ApplicationActive Control1 Intervention
The Maternal Wellness Self Help (MWSH) app was created to help individuals to identify and manage perinatal depression and anxiety. The app is designed is to meet the emotional needs of those who are pregnant, want to become pregnant or have given birth. This psycho-educational app informs and normalizes the range of emotional responses throughout the reproductive journey. By learning about perinatal mental health, this app hopes to empower patients to understand and name their experiences.
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Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
503 Previous Clinical Trials
165,723 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,723 Previous Clinical Trials
7,495,581 Total Patients Enrolled
University of California, Los AngelesOTHER
1,538 Previous Clinical Trials
10,266,880 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a pregnant Black individual and at least 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: MWSH plus Candlelit Care
- Group 2: Maternal Wellness Self Help (MWSH) Application
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.
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