Adapted Cognitive-Behavioral Therapy + Support for Prenatal Stress & Perinatal Anxiety & Depression

Not currently recruiting at 1 trial location

Overseen By Kiara A Barnett, M.Ed

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Substance use, Psychosis, Suicidal, others

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

Compensation: Varies

Number of Visits: 9

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if specific types of talk therapy and guidance can reduce stress, anxiety, and depression in pregnant women. It focuses on low-income Black women who are pregnant and experiencing stress or mental health challenges. Participants will either receive regular prenatal care or participate in adapted therapy sessions (Adapted Cognitive-Behavioral Therapy) and online support groups. Ideal candidates are pregnant Black women on Medicaid who feel stressed or anxious and are open to trying therapy. As an unphased trial, this study offers a unique opportunity to explore new therapy options that could significantly improve mental health during pregnancy.

Do I have to stop taking my current medications for this trial?

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

What prior data suggests that these interventions are safe for pregnant women?

Research has shown that Adapted Cognitive-Behavioral Therapy (CBT), particularly when tailored for different cultural groups, is generally safe. Studies have found it effective in reducing depression and anxiety during and after pregnancy, indicating that most people tolerate it well.

Patient navigation, which assists individuals in navigating healthcare systems, lacks specific safety data. However, its use in women's healthcare to support mental health during pregnancy suggests it is likely safe, though further research is needed to fully understand its effects.

In summary, both Adapted CBT and patient navigation appear safe based on current knowledge, with more robust evidence supporting CBT. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the adapted cognitive-behavioral therapy (CBT) and patient navigation treatments for prenatal stress and perinatal anxiety and depression because they are culturally tailored to meet the needs of Black or African descent populations. Unlike typical CBT, which is often standardized, this approach adapts the therapy to resonate more deeply with cultural experiences, potentially enhancing its effectiveness. Additionally, the inclusion of peer support groups, both virtual and in-person, offers a unique layer of community-based support, which is not a standard feature in many current treatment options. This combination of personalized therapy and community support could lead to more meaningful and lasting mental health benefits for expectant mothers.

What evidence suggests that this trial's treatments could be effective for prenatal stress, perinatal anxiety, and depression?

Research has shown that cognitive-behavioral therapy (CBT) effectively treats depression during and after pregnancy. One study found that adapting CBT to fit different cultures improves mental health for minority groups during pregnancy. This adaptation meets cultural needs, enhancing effectiveness for people from diverse backgrounds. In this trial, some participants will receive Adapted Cognitive-Behavioral Therapy as part of the patient navigation and treatment arm.

Patient navigation, which helps patients navigate the healthcare system, also aids pregnant individuals in accessing mental health care. Studies suggest that patient navigators can facilitate treatment access, though more research is needed to fully understand their impact. In this trial, patient navigation is included in the same treatment arm as Adapted Cognitive-Behavioral Therapy. These methods aim to support low-income Black and African descent pregnant women dealing with stress, anxiety, and depression. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for low-income Black/African Descent pregnant women under 45 years old, who are less than 28 weeks pregnant, speak English, and are experiencing stress or depression. They must be on Medicaid and able to consent. Women actively suicidal, using substances, planning to deliver outside DC, or not of the specified descent cannot join.

Inclusion Criteria

Low-income: i.e., receiving Medicaid

You identify as Black or of African descent.

Pregnant (gestational weeks ≤ 28 weeks)

Exclusion Criteria

You are experiencing severe mental illness, such as psychosis.

You are not of Black or African descent.

You are currently under the influence of drugs or alcohol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive culturally adapted CBT interventions and peer support groups based on their risk group

24 weeks

8-12 sessions (in-person or virtual)

Follow-up

Participants are monitored for mental health and well-being, and infants' development is assessed

12 months postpartum

Regular well-baby visits

What Are the Treatments Tested in This Trial?

Interventions

• Adapted Cognitive-Behavioral Therapy
• Patient Navigation

Trial Overview

The study tests if patient navigation combined with culturally adapted cognitive-behavioral therapy and peer support can help manage stress, anxiety, and depression in eligible participants. It's a randomized controlled trial meaning people will be randomly assigned to different treatment groups.

How Is the Trial Designed?

Group I: Patient Navigation and treatment Experimental Treatment 2 Interventions

In the patient navigation arm, women who do not meet diagnostic criteria (Group 2a) can participate in: (1) group-based CBT preventative intervention; (2) peer support group (virtual); or (3) both. Women in the threshold risk group, meeting diagnostic criteria for depression/anxiety (Group 2b) at baseline can participate in: (1) individual CBT treatment (2) peer support group (virtual) (3) both Prevention group includes 8 sessions based on culturally adapted CBT for Black/ of African descent populations facilitated by mental health professionals. Individual treatment includes 12 sessions based on culturally adapted CBT for Black/ of African descent populations.

Group II: Usual Care Active Control 1 Intervention

Participants will participate in usual prenatal care throughout the duration of study.

Adapted Cognitive-Behavioral Therapy is already approved in European Union, United States, Canada, Japan, China for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depression
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Bulimia nervosa

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depression
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depression
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in Japan as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depression
• Post-traumatic stress disorder (PTSD)

Approved in China as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depression

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

George Washington University

Collaborator

Trials

263

Recruited

476,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

Cognitive Behavioral Therapy (CBT) significantly improved psychological adjustment in 104 Chinese pediatric cancer patients undergoing chemotherapy, as evidenced by higher resilience scores and lower levels of depression, anxiety, and stress after the intervention.

The most notable improvements were observed in children with Yolk sac tumors and those in stage III of cancer, indicating that CBT can enhance treatment cooperation and potentially lead to a better long-term quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cognitive behavioral therapy on psychological adjustment in Chinese pediatric cancer patients receiving chemotherapy: A randomized trial. Zhang, P., Mo, L., Torres, J., et al.[2022]

In a study of 164 socioeconomically disadvantaged pregnant women, those with comorbid PTSD showed significantly greater improvement in depression severity and functioning when receiving the MOMCare intervention compared to those receiving intensive public health Maternity Support Services (MSS-Plus).

The MOMCare intervention not only improved depression and PTSD severity but also led to higher rates of depression response and remission, suggesting that collaborative care models are particularly effective for high-risk pregnant women with both major depressive disorder and PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of Collaborative Care for Perinatal Depression in Socioeconomically Disadvantaged Women: The Impact of Comorbid Posttraumatic Stress Disorder. Grote, NK., Katon, WJ., Russo, JE., et al.[2022]

A review of 16 articles highlighted the importance of culturally sensitive assessment and treatment strategies for perinatal depression in black American women, emphasizing that these approaches can improve access to care by enhancing health literacy.

The findings suggest that primary care providers should use culturally relevant screening questions to better identify and address depressive symptoms in their pregnant black American patients, leading to more effective interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based guidance for culturally sensitive assessment and interventions for perinatal depression in black american women: a synthesis of published research, 2008-2011. Cruser, dA., Asante-Ackuayi, L., Brown, S., et al.[2013]

Women are at a higher risk for perinatal mood and anxiety disorders (PMADs) during the perinatal period, and many do not receive the necessary mental health care despite the availability of effective treatments.

The development of a patient navigation (PN) service in an intensive outpatient program has shown promise in improving treatment attendance and engagement for women with PMADs, suggesting that this model could be beneficial for other care facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Stepped Care Model of Patient Navigation to Enhance Engagement with Perinatal Mental Health Care. DiSanza, CB., Geller, PA., Bonacquisti, A., et al.[2020]

Depression and anxiety are prevalent during pregnancy, especially among racial and ethnic minority women, and can negatively affect both maternal and infant health outcomes, highlighting the need for improved mental health interventions.

Universal screening for perinatal mental health issues is recommended as a strategy for nurses to enhance care, alongside various effective interventions like therapy and medication, to address the barriers to accessing mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal Anxiety and Depression in Minority Women. Gennaro, S., OʼConnor, C., McKay, EA., et al.[2021]

The Beardslee Preventive Intervention Program for Depression was successfully adapted for low-income Latino families, focusing on cultural relevance and language accessibility, with positive feedback from participants.

The adaptation process, which included pilot testing with 9 families, showed that the intervention was nonstressful and perceived as helpful, maintaining similar effectiveness to the original program while fostering a strong therapeutic alliance with preventionists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of the preventive intervention program for depression for use with predominantly low-income Latino families. D'Angelo, EJ., Llerena-Ouinn, R., Shapiro, R., et al.[2021]

Culturally adapted treatments for depression and anxiety have shown significant effectiveness in minority patients in the USA, with a pooled effect size of 1.06, indicating a strong positive impact on clinical outcomes.

The studies highlighted the importance of incorporating cultural values and beliefs into treatment, with evidence suggesting that these specific adaptations contributed to the overall effectiveness of the interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the gap for ethnic minority adult outpatients with depression and anxiety disorders by culturally adapted treatments. van Loon, A., van Schaik, A., Dekker, J., et al.[2022]

An interactive online education program for oncology staff improved communication and confidence in screening for anxiety and depression, but actual uptake was low at only 7% during the trial, indicating challenges in real-world implementation.

Despite the training being well-received in pilot tests, factors like competing demands and the online format hindered participation, suggesting that a combination of training methods may be necessary to enhance engagement and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development, acceptability and uptake of an on-line communication skills education program targeting challenging conversations for oncology health professionals related to identifying and responding to anxiety and depression. Shaw, J., Allison, K., Cuddy, J., et al.[2022]

The Family-Based Collaborative Care Model (FBCCM) was implemented with 24 mothers and their families, showing significant reductions in maternal depressive and anxiety symptoms, as well as family conflict, over a 6-month period.

The model's feasibility was supported by high attendance rates in therapy sessions (average of 9.79 sessions for mothers and 9.42 for family members), indicating that video-delivered therapy can effectively increase access to care for perinatal women in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Family-Based Collaborative Care Model for Treatment of Depressive and Anxiety Symptoms in Perinatal Women: Results From a Pilot Study. Cluxton-Keller, F., Olson, A.[2023]

The study focused on adapting a cognitive-behavioral therapy intervention to be culturally sensitive for treating depression in low-income African American women, highlighting the importance of cultural relevance in mental health treatments.

Women in the culturally adapted group showed a greater reduction in their depression scores (measured by BDI) compared to those in the non-adapted group, suggesting that culturally tailored interventions can be more effective for specific populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapted cognitive behavioral group therapy for depressed low-income African American women. Kohn, LP., Oden, T., Muñoz, RF., et al.[2022]

The article outlines a 5-step process for culturally adapting a cognitive-behavioral therapy intervention aimed at preventing perinatal depression in Latina immigrant communities, emphasizing the importance of tailoring interventions to meet specific cultural needs.

By documenting the adaptation process, the study highlights the potential for these tailored interventions to reduce disparities in mental health outcomes for low-income, ethnically diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transforming an evidence-based intervention to prevent perinatal depression for low-income Latina immigrants. Le, HN., Zmuda, J., Perry, DF., et al.[2021]

The cognitive-behavioral therapy (CBT) intervention significantly reduced depressive symptoms during pregnancy among 217 high-risk Latina participants, particularly for those who attended at least 4 classes.

Despite the reduction in symptoms, the overall incidence of major depressive episodes was similar between the CBT group (7.8%) and usual care group (9.6%), indicating that while CBT was effective in symptom management, it did not significantly lower the rate of clinical depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a preventive intervention for perinatal depression in high-risk Latinas. Le, HN., Perry, DF., Stuart, EA.[2021]

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