RISE Program for Pregnancy-Related Depression and Anxiety

(RISE Trial)

Overseen By Pearl Heumann, BS

Age: 18+

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Psychosis, Perinatal loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to support Black pregnant women experiencing pregnancy-related depression and anxiety. It tests a mobile health app designed to enhance communication, promote self-advocacy, and provide culturally supportive mental health resources. The goal is to determine if this approach can reduce depression and anxiety while improving overall health outcomes. Black pregnant women with access to a smartphone, tablet, or computer may be suitable for this study. As a Phase 2, Phase 3 trial, the study measures the app's effectiveness in a larger group and represents the final step before FDA approval, offering participants a chance to contribute to significant advancements in mental health care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It would be best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the RISE program, designed to support Black pregnant women, is promising in providing mental health support during pregnancy. The program uses a mobile app to build communication and self-advocacy skills, aiming to reduce stress and improve mental health.

The RISE program is based on cognitive behavioral therapy (CBT), a well-established method for treating depression and anxiety. CBT is widely regarded as safe and effective. The app offers self-guided tools and peer coaching, which are both convenient and secure. Importantly, it provides culturally affirming support, enhancing the experience for Black mothers.

The trial is in its later stages, indicating that the treatment has undergone safety testing and is likely well-tolerated. Participants in similar programs have generally reported positive results with few side effects. Therefore, RISE is expected to be safe for participants. However, as with any treatment, individual reactions may vary. Discussing any concerns with a healthcare provider is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RISE Program for Pregnancy-Related Depression and Anxiety because it offers culturally tailored mental health support specifically for Black pregnant women, a group often overlooked in standard care. Unlike traditional options, which may not address cultural nuances, the Candlelit Care app integrates cognitive behavioral therapy with culturally affirming resources, providing a secure space for self-guided therapeutic tools and peer coaching. This innovative approach not only helps identify whether symptoms need further treatment but also empowers women with self-advocacy skills and a supportive network, addressing unique challenges like racial discrimination and interpersonal conflicts around childbirth.

What evidence suggests that this trial's treatments could be effective for pregnancy-related depression and anxiety?

This trial will compare two digital mental health tools for pregnancy-related depression and anxiety. Research has shown that the Candlelit Care app, one of the treatment options in this trial, is based on cognitive behavioral therapy (CBT) and can help manage mood and anxiety issues during and after pregnancy. This app offers mental health support that respects cultural differences, aiding Black pregnant women in improving their communication and self-advocacy skills. Studies have found that digital mental health tools like this can reduce stress and depression during pregnancy by providing access to therapy tools and support from others. The app also aims to reduce stress related to discrimination, potentially leading to better mental and physical health.

The Maternal Wellness Self Help (MWSH) app, another treatment option in this trial, helps pregnant individuals recognize and manage depression and anxiety. It provides information about mental health during and after pregnancy, helping users understand that a range of emotions is normal. This educational approach can help people make sense of their feelings and improve their mental well-being. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

English speaking

Access to a tablet, smartphone, or computer capable of running the apps

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Psychosis

Perinatal loss

Individuals outside of the US

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the culturally relevant mHealth intervention (MWSH + Candlelit Care) or the standard of care control (MWSH) to improve perinatal mental and physical health outcomes.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including additional PMAD screening and patient navigation to mental health and/or medical care if needed.

6 months - 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women

Trial Overview 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.

How Is the Trial Designed?

Group I: MWSH plus Candlelit Care Experimental Treatment 1 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) Application Active Control 1 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.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Maternal Mental Health NOW

Collaborator

Trials

2

Recruited

350+

Candlelit Therapy

Collaborator

Trials

1

Recruited

150+

Published Research Related to This Trial

African American women face unique risks for depression, which are worsened by a behavioral health system that does not adequately address their specific needs.

The Healthy Start Initiative provides a valuable resource for addressing perinatal depression in African American women by offering culturally appropriate case management and support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based perinatal depression services for African American women: the healthy start model. Ley, CE., Copeland, VC., Flint, CS., et al.[2022]

The Healthy Start Screen (HSS) effectively identifies pregnant women at risk for postpartum depression (PPD), as indicated by their responses to specific risk factors such as feelings of depression, loneliness, and financial troubles.

Women who reported feeling down, having received mental health services, or experiencing difficulties with bills were significantly more likely to score 12 or higher on the Edinburgh Postnatal Depression Scale (EPDS), highlighting the HSS's utility in early detection of PPD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the utility of the Healthy Start Screen to predict an elevated Edinburgh Postnatal Depression Scale score. Padilla, MM., Roussos-Ross, D., Goodin, AJ.[2021]

African American women are at a higher risk for postpartum depression (PPD), and the review highlights various interventions, including group and individual psychosocial support, internet-based programs, and integrated care, that may help address this issue.

While some studies showed improvements in depression symptoms, particularly in high-risk or culturally tailored groups, the overall results were mixed, indicating a need for further research to identify the most effective interventions for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Black with 'Baby Blues': A Systematic Scoping Review of Programs to Address Postpartum Depression in African American Women. Robertson, K., Wells, R.[2023]

The study analyzed data from 2,731 participants and found that African-American women reported higher levels of depressive symptoms during pregnancy compared to White women, particularly among employed individuals.

Total discrimination, including gender and economic discrimination, was positively associated with depressive symptoms in both African-American and White women, suggesting that experiences of discrimination may contribute to mental health challenges during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discrimination and symptoms of depression in pregnancy among African American and White women. Canady, RB., Bullen, BL., Holzman, C., et al.[2022]

In a study of African American women who were 14-17 weeks pregnant, two-thirds reported significant depressive symptoms, indicating a high prevalence of antepartum depression during this typically positive stage of pregnancy.

Factors such as age, perceived stress, and anxiety were found to predict depressive symptoms, highlighting the importance of early identification and intervention for stress and anxiety in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and Predictors of Depressive Symptoms in Pregnant African American Women. Jallo, N., Elswick, RK., Kinser, P., et al.[2022]

In a study of 1,044 urban, high-risk African-American pregnant women, 44% were found to have moderate to severe depressive symptoms, highlighting a significant mental health concern in this population.

Factors such as maternal age, intimate partner violence, and substance use were linked to increased depressive symptoms, while emotional support and positive feelings about the pregnancy were associated with lower depressive symptoms, indicating both risk and protective factors that need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding depressive symptoms among high-risk, pregnant, African-American women. Molina, KM., Kiely, M.[2022]

The ROSE Program, an interpersonal intervention for low-income, rural African-American pregnant women at risk for postpartum depression (PPD), showed initial effectiveness in improving postpartum adjustment compared to treatment as usual (TAU).

While there were no significant differences in depressive symptoms or parental stress between the ROSE Program and TAU at 3 months postpartum, participants in the ROSE Program reported improvements in depressive symptoms over time, suggesting potential benefits of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A depression preventive intervention for rural low-income African-American pregnant women at risk for postpartum depression. Crockett, K., Zlotnick, C., Davis, M., et al.[2022]

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12213272/

Development of Powerly, unguided mobile app ... Up to 30 % of pregnant individuals experience high levels of stress. At the same time, 15–20 % of new mothers develop postpartum depression, and 25–35 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10098336/

Utilization of digital prenatal services and management ... While there are many potential ways that digital services might help pregnant people manage their mental health, research has indicated that education and ...

4. womensmentalhealth.org womensmentalhealth.org/posts/new-research-study-a-behavioral-activation-app-for-depression-during-pregnancy/

New Research Study: A Behavioral Activation App ... We are now recruiting for a study using a novel app using behavioral activation to treat depression during pregnancy.

5. researchprotocols.org researchprotocols.org/2025/1/e59461

Feasibility of a Mobile App–Based Cognitive-Behavioral ... Maya-Perinatal Skills Program (M-PSP) uses evidence-based strategies to help individuals manage their mood and anxiety symptoms during pregnancy ...

6. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT05552053

Resources, Inspiration, Support and Empowerment (RISE) for ... Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women. a study on Pregnancy Depression Postpartum Depression Anxiety ...

7. withpower.com withpower.com/trial/phase-2-and-3-depression-9-2022-ac428

RISE Program for Pregnancy-Related Depression and ... Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum.

8. cedars-sinai.org cedars-sinai.org/discoveries/research-aims-to-improve-maternal-health-equity.html

Research Aims to Improve Maternal Health Equity Cedars-Sinai actively measures and studies racial and ethnic disparities in maternal healthcare and implements patient-centered projects to resolve any ...

9. ens.lacity.org ens.lacity.org/clk/commissionagend/clkcommissionagend3412182303_08122024.pdf

Resources, Inspiration, Support and Empowerment ( ... Race/ethnicity: More American Indian (23%) and African American (18%) respondents reported experiencing postpartum depression compared to White.