The DC Mother-Infant Behavioral Wellness Program

Perinatal Depression Clinical Trial

Official title:

Advancing Perinatal Mental Health and Well-Being: The DC Mother-Infant Behavioral Wellness Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345834
• Other study ID #: Pro00015379
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: August 2024

Study information

• Verified date: February 2023
• Source: Children's National Research Institute
• Contact: Huynh-Nhu Le, PhD
• Phone: (202) 994-6808
• Email: hnle[@]gwu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled study will examine the effectiveness of patient navigation with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black/of African Descent pregnant women who are experiencing stress, anxiety, and/or depression.

Description:

The overarching objective is to develop and evaluate a collaborative, multi-dimensional and culturally tailored community-based model of integrated perinatal MH care. The target population is low-income Black/of African descent women with pregnancy-related stress, anxiety, and depression. There are two specific aims: (1) to refine an individualized plan to integrate patient navigation and a culturally adapted cognitive-behavioral (CBT) intervention for low-income Black/of African Descent women designed to increase recruitment and retention within the healthcare community system, and (2) through a two-arm prospective randomized controlled design, women who are subthreshold and threshold risk for prenatal stress, depression and/or anxiety will participate in one of two interventions: (a) existing prenatal intervention (usual care); or (b) patient navigation plus culturally adapted CBT, and peer support groups.

The investigators will screen 1,000 low-income pregnant AA women (18-45 years of age) in their second pregnancy visit with validated tools for stress, anxiety, and depression. A total of 700 study participants will be recruited from urban prenatal care centers in the Washington DC area and will be randomized Usual Care of Intervention conditions above (n=350/condition). Following randomization, participants will participate in a diagnostic interview based on DSM-5 criteria to 'self-select' themselves into 1 of 2 groups (i.e., 'threshold' or 'subthreshold'). Threshold includes women who meet criteria for depression or anxiety based on DSM-5 diagnostic criteria. Subthreshold includes all other women who do not meet DSM criteria). In the intervention arm, participants in the threshold group will receive a 1:1 CBT treatment intervention, and participants in the subthreshold group will receive a group CBT intervention. Both threshold groups will also include patient navigation and participation in a peer support group. Participants will complete standardized health, mental health, and well-being questionnaires during pregnancy at their prenatal site, and up to 12 months after delivery at their well-baby visits, when they also will complete questionnaires about their infants' development and behavior. All infants also will undergo a standardized developmental test at 12 months. Health care utilization and outcomes also will be collected through electronic medical records.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: August 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Black/of African Descent

• Pregnant (gestational weeks = 28 weeks)

• Age 18-45

• English proficient

• Receiving services in 1 of 4 study sites above

• Low-income: i.e., receiving Medicaid

• Subthreshold or threshold risk for maternal distress (stress, depression, and/or anxiety)

• Able to provide consent

Exclusion Criteria:

• age <18

• Currently under the influence of a substance(s)

• Experiencing psychosis

• Critical (clinical) risk: actively suicidal or homicidal

• Not Black/of African Descent

• Planning to deliver outside DC

Related Conditions & MeSH terms

• Depression
• Perinatal Anxiety
• Perinatal Depression
• Prenatal Stress

Intervention

Behavioral:
• Patient Navigation
Participants in arm 2 will receive patient navigation provided by humans (rather than e-navigation) to provide personalized care to include support, resources, and referrals to address psychosocial issues that arise during the perinatal period. Patient navigation is available to participants through 12 months postpartum.
• Adapted Cognitive-Behavioral Therapy
Participants who do not meet diagnostic criteria (Group 2a) will participate in a prevention group which includes 8 sessions based on culturally adapted CBT for Black/ of African descent populations facilitated by mental health professionals. Participants who meet diagnostic criteria (Group 2b) will participate in individual treatment which includes 12 sessions based on culturally adapted CBT for Black/ of African descent populations.

Locations

Country	Name	City	State
United States	Unity Healthcare - Brentwood	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Children's National Research Institute	George Washington University, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Stress at 24 weeks of pregnancy to 12 months postpartum	Perceived Stress Scale: A 10-item questionnaire to measure the self-reported level of stress in the respondents by assessing feelings and thoughts during the last month. Each item is scored from 0 (never) to 5 (very often) with a range of 0 to 40 for the total score of the scale. A higher level of stress is indicated by higher scores on this scale.	Stress will be measured at 24 weeks of pregnancy through infant age of 12 months
Primary	Change in Depression at 24 weeks of pregnancy to 12 months postpartum	Edinburgh Postnatal Depression Scale: A 10-item scale used to indicate whether a parent has symptoms that are common in women with depression during pregnancy and in the year following the birth of a child. Each item is scored from 0 (As much as I ever did) to 3 (Not at all) with a range of 0 to 30. Higher level of depression is indicated by a higher score on this scale.	2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum
Primary	Change in Anxiety at 24 weeks of pregnancy to 12 months postpartum	General Anxiety Disorder-7 (GAD-7): A 7-item scale to measure levels of anxiety in respondents by assessing feelings and thoughts over the past 2 weeks. Each item is scored from 0 (Not at all) to 3 (Nearly every day) with a range of 0 to 21. Higher level of depression is indicated by a higher score on this scale.	2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum