Status:
WITHDRAWN
CALM for Pregnant and Post-Partum Women
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Anxiety
Depression
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Anxiety and depression is common along pregnant mothers and has been found to increase risk for negative outcomes in both mothers and infants. These risks can include low infant birth weight, negative...
Detailed Description
Setting and Sample Women will be recruited from six clinics in Alameda County that provide prenatal care. In clinic settings, women will be approached by a trained and culturally sensitive research gr...
Eligibility Criteria
Inclusion
- English or Spanish speaking
- Black or Hispanic/Latina women
- Over the age of 18
- Live or work in Oakland, CA.
- CALM eligibility is based on two levels of screening. First, participants who score above clinical cutoffs on Overall Anxiety Severity and Impairment Scale (OASIS) or on the Edinburgh Perinatal Depression Scale (EPDS), or on the Pregnancy Stress and Anxiety Scale (PSAS) are eligible . A second screen using the Mini-Mental State Examination (MMSE) is required , as CALM and CBT are only effective in specific conditions and is not recommended for individuals with severe mental illness (e.g. bipolar disorder and psychosis) or cognitive impairment.
Exclusion
- Multiple gestation
- Serving as birth surrogate
- Used reproductive technology
- Women will also be excluded if they do not meet the above criteria (i.e., they do not exceed the clinical cutoffs) or if they have a history of bipolar disorder or psychosis (treated within the past year).
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03351465
Start Date
January 1 2020
End Date
June 30 2020
Last Update
September 26 2019
Active Locations (1)
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1
University of California, San Francisco
Oakland, California, United States, 94612