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

Trial Summary

What is the purpose of this trial?

Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs. This rate doubles for those with adverse perinatal outcomes (APO) and triples in Black women. Recent research points to racism as one significant source of these health disparities. Cultural adaptations to improve communication with providers decrease rates of depression in minority patients as well as improve adherence to treatment, insight and alliance. Discrimination stress and worries about experiencing medical consequences are thought to increase systemic inflammation, a mechanism known to drive mental and physical symptoms. Inflammation has been implicated in both PMADs and APO, suggesting a shared underlying etiology. Evidence from our work suggests that inflammation contributes to the pathophysiology of PMADs. The proposed pilot randomized control trial will allow the investigators to build on promising preliminary results and identify whether our culturally relevant mobile Health (mHealth) intervention is effective in improving outcomes among Black pregnant women randomized to the intervention compared to a control group. The culturally relevant modules include building communication and self-advocacy skills and provide a support network. The primary objective of this research is to provide guidance for clinical care of Black women during the perinatal period, with the goal to improve mental health and physical health outcomes. A secondary goal is to examine novel inflammatory signatures that change as a function of the intervention to reduce PMADs in this population. As inflammation may be diagnostic of PMADs, identification of its role may shed light of potential intervention targets and provide critical knowledge to improve women's long-term health. PMAD symptoms will be assessed prospectively in 150 Black pregnant women, half of whom will be randomized to receive the culturally relevant mHealth intervention. The investigators hypothesize that women in the intervention group will have reduced rates of PMADs and APOs, an increase in adherence to mental health treatment and will report increased self-advocacy skills, increased communication with providers, and reduced levels of discrimination related stress. Participants will also have improved biological risk indicators including lower circulating C-reactive protein and a transcription profile of differentially expressed inflammatory genes, marked by a decreased activity of inflammatory transcription factors from blood spots. Given the high burden of both PMADs and APOs among Black mothers and the numerous consequences on maternal and child outcomes, it is imperative that investigators develop and implement effective interventions, and test the biological mechanisms that might drive these effects. This work is interdisciplinary, building on a network of community advocates to implement a novel mHealth intervention informed by real world experiences designed to enhance self-advocacy, reduce stress and prevent adverse outcomes

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.

What data supports the effectiveness of the RISE treatment for pregnancy-related depression and anxiety in Black pregnant women?

The ROSE Program, a similar treatment for postpartum depression in low-income African-American pregnant women, showed that participants reported better postpartum adjustment and improvement in depressive symptoms over time compared to those who received usual care. This suggests that programs like RISE, which focus on interpersonal support, may be effective in improving mental health outcomes for Black pregnant women. ^{1 2 3 4 5}

How is the RISE treatment for pregnancy-related depression and anxiety unique?

The RISE treatment is unique because it specifically focuses on providing culturally tailored support and empowerment for Black pregnant women, addressing their unique stressors and mental health needs, which are often overlooked in standard treatments. ^{1 2 4 6 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Austria pubmed.ncbi.nlm.nih.gov

A depression preventive intervention for rural low-income African-American pregnant women at risk for postpartum depression. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Community-based perinatal depression services for African American women: the healthy start model. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Discrimination and symptoms of depression in pregnancy among African American and White women. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Prevalence and Predictors of Depressive Symptoms in Pregnant African American Women. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Assessing the utility of the Healthy Start Screen to predict an elevated Edinburgh Postnatal Depression Scale score. [2021]