NCT01045655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

4.2 years

First QC Date

January 8, 2010

Last Update Submit

January 13, 2016

Conditions

Depression

Keywords

DepressionPerinatal carePostpartum periodPregnancyFemaleLow-income population

Outcome Measures

Primary Outcomes (1)

  • SCL-20 depression

    baseline, 3, 6 12, 18 month follow-ups

Secondary Outcomes (10)

  • Maternal health services utilization use and estimated costs

    baseline, 3, 6 12, 18 month follow-ups

  • Pregnancy, delivery, birth outcomes

    6 month follow-up

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

    6, 12, 18 month follow-ups

  • Depression free days & Quality Adjusted Life Years (EuroQol)

    3, 6, 12, 18 month follow-ups

  • Quality of depression care process

    3, 6, 12, 18 month follow-ups

  • +5 more secondary outcomes

Study Arms (2)

MOMCare intervention

EXPERIMENTAL

Depression care treatment with study depression care specialist (brief interpersonal psychotherapy or pharmacotherapy)

Behavioral: MOMCare

Care Plus

NO INTERVENTION

Usual care group; referral to community mental health treatment

Interventions

MOMCareBEHAVIORAL

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

MOMCare intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (4)

  • 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.

    PMID: 26345179RESULT

  • Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.

    PMID: 37146219DERIVED

  • 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.

    PMID: 28076671DERIVED

  • 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.

    PMID: 25016216DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Nancy K Grote, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 11, 2010

Study Start

January 1, 2010

Primary Completion

April 1, 2014

Study Completion

August 1, 2014

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

US(1)