RISE Program for Pregnancy-Related Depression and Anxiety (RISE Trial)

Los Angeles, CA

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

No Placebo-Only Group

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.

See full description

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months - 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months - 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months - 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety symptoms

Mental Depression

PTSD Symptoms

Secondary study objectives

Communication

Discrimination stress

Self-Advocacy

Other study objectives

Inflammation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Do I qualify?Apply below to find out