MOMCare: Culturally Relevant Treatment Services for Perinatal Depression
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 8, 2010 | ||||
| Last Updated Date | May 8, 2013 | ||||
| Start Date ICMJE | January 2010 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
SCL-20 depression [ Time Frame: baseline, 3, 6 12, 18 month follow-ups ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Number of depression treatment sessions attended, depression severity and diagnosis (PHQ-9 depression, SCL-20, Edinburgh Postnatal Depression Scale), and Social Functioning (Work & Social Adjustment, Social & Leisure, Social Support, IFSAC) [ Time Frame: screening, baseline, 3, 6 12, 18 month follow-ups ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01045655 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | MOMCare: Culturally Relevant Treatment Services for Perinatal Depression | ||||
| Official Title ICMJE | For Moms: Culturally Relevant Treatment Services for Perinatal Depression | ||||
| Brief Summary | The study will evaluate the effectiveness of a culturally relevant, multi-component intervention for antenatal depression. The intervention includes an engagement session, and the woman's choice of brief interpersonal psychotherapy and/or pharmacotherapy in a stepped care treatment for depression model. |
||||
| Detailed Description | The randomized control trial will evaluate the effects of a culturally relevant, multi-component intervention for antenatal depression. MOMCare has the potential to overcome patient, provider, and system-level barriers to care and engage depressed, low-income women in evidence-based treatments to reduce antenatal depressive symptoms, improve maternal psychosocial functioning, and ameliorate postpartum depression. Specific Aim 1: To evaluate the impact of MOMCare on treatment engagement and retention. Specific Aim 2: To evaluate the impact of MOMCare on maternal clinical symptoms and functional outcomes. Specific Aim 3: To conduct an incremental cost-effectiveness analysis for a health care and welfare agency perspective that includes a) tracking the medical costs of health service use in MOMCare and usual care patients; b) monitoring the use of infant preventative health services in both groups; and c) tracking the percentage of women on Medicaid and the percentage working in both groups. The intervention will be assessed through a practical randomized controlled trial in which we have recruited 168 pregnant women with major depression and/or dysthymia who were on Medicaid and/or received Maternal Support Services (MSS) in selected public health centers in Seattle - King County (PHSKC). Patients who were eligible and consented to study enrollment were randomly assigned to either usual care (UC) or MOMCare. Baseline and four follow-up assessments (3 - 18 months post-baseline) are scheduled for study participants in both groups. The MOMCare intervention includes a choice of brief interpersonal psychotherapy or collaborative management of antidepressant medication. Treatment response will be monitored, and the treatment will be adjusted as necessary (adding treatments, increasing dosages). |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE | Depression | ||||
| Intervention ICMJE | Behavioral: MOMCare
8 sessions of brief interpersonal psychotherapy or medication management; maintenance sessions through 12 months postpartum. |
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 168 | ||||
| Estimated Completion Date | January 2014 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01045655 | ||||
| Other Study ID Numbers ICMJE | R01 MH084897, R01MH084897, R01 MH084897 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Nancy Grote, University of Washington | ||||
| Study Sponsor ICMJE | University of Washington | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Washington | ||||
| Verification Date | May 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||