Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT05345834
Brief 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.
Detailed 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.
Study:
NCT05345834
Study Brief:
Protocol Section:
NCT05345834