Background: Major depressive episodes occur throughout a woman's lifespan, with the highest rates during the reproductive and menopausal transition years. During this time, OB-GYNs are the only providers whom many women regularly see. Low income and minority women are particularly likely to seek their routine care in OB-GYN clinics. There are marked gaps in accuracy of diagnosis and quality of depression care in OB-GYN clinics, with disparities in quality of depression care which exceed those seen in primary care clinics. Models incorporating depression care into clinical settings may be adaptable to OB-GYN settings but have not been tested outside of the perinatal period. Most women seen by OB-GYNs are not pregnant;thus, studies focusing solely on perinatal depression excludes a large number of women who could benefit from care. No studies to date have been completed that have adapted depression care models to OB-GYN clinics as a whole. Research Goal: We propose a three-part intervention, integrated with OB-GYN care, consisting of (i) enhanced education;(ii) engagement;and (iii) depression care management (with antidepressant monitoring and/or provision of brief psychotherapy). We hypothesize that a three-part depression intervention, integrated into the OB-GYN clinical setting, will improve treatment outcomes for depression, functional outcomes, and satisfaction with depression care. Study Design: In the proposed randomized controlled trial, 260 OB-GYN clinic patients with major depression and/or dysthymia will be assigned to either: 1) an integrated depression intervention or 2) usual care (UC). We will screen approximately 8,300 patients presenting for scheduled clinic appointments at two urban OB-GYN clinics over 18-months for major depression/dysthymia. A large number of these patients are low-income and minority women. Potentially eligible patients may also be referred by a clinic provider or reply to informational flyers posted in the clinics. The integrated depression intervention will last 12 months. Outcomes will be assessed at baseline and at 6, 12, and 18 months by telephone interviews by blinded research staff.
Aims : Our Primary Aims are: 1) To evaluate, compared to UC, the impact of an integrated OB-GYN depression intervention on depression treatment outcomes, including change in depressive symptoms and depression treatment response;and 2) To evaluate, compared to UC, the impact of an integrated OB-GYN depression intervention on functional outcomes. Our Secondary Aims are: 3) To evaluate, compared to UC, the impact of an integrated OB-GYN depression intervention on quality of depression care indicators, including number of therapy visits, and dose, duration, and adherence to antidepressant medications;and on satisfaction with depression care, including patient and provider satisfaction, and provider attitudes toward depression care in OB-GYN clinics;and 4) [To identify potential facilitators and barriers to sustainability of the integrated OB-GYN intervention.]
The results of our proposed randomized controlled trial will greatly impact public health by satisfying an unmet need for effective depression services for all women seen in the OB-GYN clinical setting. The potential improvements in depression treatment outcomes and quality of life for the large proportion of women who receive their care in this setting will be substantial.
