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Completed

NCT Number: NCT01045655

MOMCare: Culturally Relevant Treatment Services for Perinatal Depression

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98105, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MOMCare

Behavioral

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

Primary outcomes

  1. SCL-20 depression

    Time frame: baseline, 3, 6 12, 18 month follow-ups

Secondary outcomes

  1. Maternal health services utilization use and estimated costs

    Time frame: baseline, 3, 6 12, 18 month follow-ups

  2. Pregnancy, delivery, birth outcomes

    Time frame: 6 month follow-up

  3. Child services & outcomes (immunizations, well-child visits)

    Time frame: 6, 12, 18 month follow-ups

  4. Depression free days & Quality Adjusted Life Years (EuroQol)

    Time frame: 3, 6, 12, 18 month follow-ups

  5. Quality of depression care process

    Time frame: 3, 6, 12, 18 month follow-ups

  6. Number of depression treatment sessions attended

    Time frame: 3, 6, 12, 18 month follow-ups

  7. PHQ-9 depression

    Time frame: screening, baseline, 3, 6, 12, 18 month follow-ups

  8. Edinburgh Postnatal Depression Scale

    Time frame: baseline, 3, 6, 12, 18 month follow-ups

  9. Social Functioning (Work & Social Adjustment, Social & Leisure, Social Support)

    Time frame: baseline, 3, 6, 12, 18 month follow-ups

  10. Inventory of Functional Status After Childbirth (IFSAC)

    Time frame: 6, 12, 18 month follow-ups

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

For Moms: Culturally Relevant Treatment Services for Perinatal Depression

Acronym: MOMCare

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 11, 2010
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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