Clinical trial NCT01045655: MOMCare: Culturally Relevant Treatment Services for Perinatal Depression
Official title: For Moms: Culturally Relevant Treatment Services for Perinatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Perinatal care
Postpartum period
Pregnancy
Female
Low-income population
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-01-11
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: SCL-20 depression
timeFrame: baseline, 3, 6 12, 18 month follow-ups
Secondary outcomes:
measure: Maternal health services utilization use and estimated costs
timeFrame: baseline, 3, 6 12, 18 month follow-ups
measure: Pregnancy, delivery, birth outcomes
timeFrame: 6 month follow-up
measure: Child services & outcomes (immunizations, well-child visits)
timeFrame: 6, 12, 18 month follow-ups
measure: Depression free days & Quality Adjusted Life Years (EuroQol)
timeFrame: 3, 6, 12, 18 month follow-ups
measure: Quality of depression care process
timeFrame: 3, 6, 12, 18 month follow-ups
measure: Number of depression treatment sessions attended
timeFrame: 3, 6, 12, 18 month follow-ups
measure: PHQ-9 depression
timeFrame: screening, baseline, 3, 6, 12, 18 month follow-ups
measure: Edinburgh Postnatal Depression Scale
timeFrame: baseline, 3, 6, 12, 18 month follow-ups
measure: Social Functioning (Work & Social Adjustment, Social & Leisure, Social Support)
timeFrame: baseline, 3, 6, 12, 18 month follow-ups
measure: Inventory of Functional Status After Childbirth (IFSAC)
timeFrame: 6, 12, 18 month follow-ups
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Nancy K Grote, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Grote NK, Katon WJ, Russo JE, Lohr MJ, Curran M, Galvin E, Carson K. A Randomized Trial of Collaborative Care for Perinatal Depression in Socioeconomically Disadvantaged Women: The Impact of Comorbid Posttraumatic Stress Disorder. J Clin Psychiatry. 2016 Nov;77(11):1527-1537. doi: 10.4088/JCP.15m10477.
citation: Grote NK, Katon WJ, Lohr MJ, Carson K, Curran M, Galvin E, Russo JE, Gregory M. Culturally relevant treatment services for perinatal depression in socio-economically disadvantaged women: the design of the MOMCare study. Contemp Clin Trials. 2014 Sep;39(1):34-49. doi: 10.1016/j.cct.2014.07.001. Epub 2014 Jul 10.