Perinatal Depression Clinical Trial
Official title:
Advancing Perinatal Mental Health and Well-Being: The DC Mother-Infant Behavioral Wellness Program
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Unity Healthcare - Brentwood | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Children's National Research Institute | George Washington University, Patient-Centered Outcomes Research Institute |
United States,
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 |
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