Depression Clinical Trial
Official title:
Depression Intervention for Financially Disadvantaged Pregnant Women.
This study will evaluate the effectiveness of an interpersonal therapy treatment called the Postpartum Prevention Program in preventing the development of postpartum depression in pregnant women who are financially disadvantaged.
Status | Completed |
Enrollment | 207 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Speaks and comprehends English sufficiently to complete the study procedures - Willing and able to receive public assistance - Between 20 and 34 weeks of gestation - Score of greater than 27 on the Cooper Risk Survey to identify risk of PPD Exclusion Criteria: - Currently receiving mental health services from a healthcare provider - Meets criteria for a current affective disorder, anxiety disorder (excluding simple phobia), substance use disorder, or psychosis, as determined by the relevant modules of the Structured Clinical Interview for DSM-IV Nonpatient Version (SCID-NP) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Women and Infants Hospital | Providence | Rhode Island |
United States | Womens' Care Inc. | Providence | Rhode Island |
United States | Thundermist Health Center | Woonsocket | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Women and Infants Hospital of Rhode Island | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Longitudinal Interval Follow-up Examination (LIFE) | Measured at Months 3, 6, and 12 postpartum | Yes | |
Secondary | Adjustment disorder or depression not otherwise specified (NOS) as measured by the Structured Clinical Interview for DSM Disorders (SCID) | Measured within Month 6 postpartum | No |
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