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

NCT05552053 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: Pro000022831R21MD017396-01A1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Related; Pregnancy Complications; Pregnancy, High Risk; Depression; Depression, Postpartum; Perinatal Depression; Anxiety; Anxiety in Pregnancy; Stress, Psychological; Racism; Discrimination, Racial; Inflammation

Outcome Measures

Primary Outcomes (3)

• Depression symptoms

  Reduced symptoms of depression assessed by the Edinburgh Postnatal Depression Scale (EPDS)

  6 months - 1 year

• Anxiety symptoms

  Reduced symptoms of anxiety assessed by the Overall Anxiety Severity and Impairment Scale (OASIS)

  6 months - 1 year

• PTSD Symptoms

  Reduced symptoms of post-traumatic stress symptoms assessed by the Impact of EVents Scale (IES)

  6 months - 1 year

Secondary Outcomes (3)

• Communication

  6 months - 1 year

• Self-Advocacy

  6 months - 1 year

• Discrimination stress

  6 months - 1 year

Other Outcomes (1)

• Inflammation

  6 months - 1 year

Study Arms (2)

Maternal Wellness Self Help (MWSH) Application

ACTIVE COMPARATOR

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.

Device: MWSH

MWSH plus Candlelit Care

EXPERIMENTAL

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.

Device: MWSH plus Candlelit Care

Interventions

MWSH plus Candlelit Care DEVICE

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.

MWSH plus Candlelit Care

MWSH DEVICE

The Maternal Wellness Self Help (MWSH) app was created to help individuals to 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.

Maternal Wellness Self Help (MWSH) Application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Pregnant Black individuals, at least 18 years of age
• English speaking
• Access to a tablet, smartphone, or computer capable of running the apps

You may not qualify if:

• Psychosis
• Perinatal loss
• Individuals outside of the US

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Institutes of Health (NIH): collaborator
• Candlelit Therapy: collaborator
• University of California, Los Angeles: collaborator
• Maternal Mental Health NOW: collaborator

Study Sites (1)

Cedars Sinai

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Pregnancy Complications; Depression; Depression, Postpartum; Anxiety Disorders; Stress, Psychological; Racism; Inflammation

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior; Puerperal Disorders; Depressive Disorder; Mood Disorders; Mental Disorders; Prejudice; Social Behavior; Social Discrimination; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the participants nor the investigators will know which group women have been randomized to. The care provider must know, in order to properly assist with use of the mobile health application.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Model Details: This RCT will examine the clinical effectiveness of the Candlelit Care mobile health intervention at reducing mental and physical health risk compared to the standard Maternal Wellness Self-Help (MWSH) mobile health application. Hypothesis 1a: Compared to a standard of care control group (N=75), Black pregnant women (N=75) randomized to MWSH + Candlelit Care and structured postpartum follow up will have reduced rates of APOs and PMADs. Hypothesis 1b: Among women diagnosed with PMADs, participants in the intervention group will have an increase in adherence to recommended postpartum mental health treatment. They will also report increased self-advocacy skills, increased communication with providers, and reduced levels of perceived medical discrimination.

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 23, 2022
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)