MOMCare: Culturally Relevant Treatment Services for Perinatal Depression

Depression Clinical Trial

— MOMCare  

Official title:

For Moms: Culturally Relevant Treatment Services for Perinatal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045655
• Other study ID #: R01MH084897
• Secondary ID: R01MH084897
• Status: Completed
• Phase: N/A
• First received: January 8, 2010
• Last updated: January 13, 2016
• Start date: January 2010
• Est. completion date: August 2014

Study information

• Verified date: January 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 or older

• pregnant: 12-32 weeks gestation

• able to speak English

• telephone access

• major depressive disorder or dysthymia

• on Medicaid

• receiving health care in King County, Washington

Exclusion Criteria:

• currently in psychotherapy

• currently receiving pharmacotherapy from a psychiatrist

• high suicide risk

• history of bipolar disorder

• history of schizophrenia

• substance use or dependence in previous 3 months

• currently in a relationship with severe interpersonal violence

• history of repetitive self-harm behavior

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asphyxia Neonatorum
• Depression
• Depressive Disorder

Intervention

Behavioral:
• MOMCare
8 sessions of brief interpersonal psychotherapy or medication management; maintenance sessions through 12 months postpartum.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Grote NK, Katon WJ, Russo JE, Lohr MJ, Curran M, Galvin E, Carson K. COLLABORATIVE CARE FOR PERINATAL DEPRESSION IN SOCIOECONOMICALLY DISADVANTAGED WOMEN: A RANDOMIZED TRIAL. Depress Anxiety. 2015 Nov;32(11):821-34. doi: 10.1002/da.22405. Epub 2015 Sep 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCL-20 depression		baseline, 3, 6 12, 18 month follow-ups	No
Secondary	Maternal health services utilization use and estimated costs		baseline, 3, 6 12, 18 month follow-ups	No
Secondary	Pregnancy, delivery, birth outcomes		6 month follow-up	No
Secondary	Child services & outcomes (immunizations, well-child visits)		6, 12, 18 month follow-ups	No
Secondary	Depression free days & Quality Adjusted Life Years (EuroQol)		3, 6, 12, 18 month follow-ups	No
Secondary	Quality of depression care process		3, 6, 12, 18 month follow-ups	No
Secondary	Number of depression treatment sessions attended		3, 6, 12, 18 month follow-ups	No
Secondary	PHQ-9 depression		screening, baseline, 3, 6, 12, 18 month follow-ups	No
Secondary	Edinburgh Postnatal Depression Scale		baseline, 3, 6, 12, 18 month follow-ups	No
Secondary	Social Functioning (Work & Social Adjustment, Social & Leisure, Social Support)		baseline, 3, 6, 12, 18 month follow-ups	No
Secondary	Inventory of Functional Status After Childbirth (IFSAC)		6, 12, 18 month follow-ups	No