DepressionMOMCareNCT01045655
MOMCare: Culturally Relevant Treatment Services for Perinatal Depression
A study testing MOMCare in people with Depression, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression
- What is being tested?
- MOMCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: For Moms: 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.
Read the 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).
- Conditions
- Depression
- Being tested
- MOMCare
- Keywords
- Depression, Perinatal care, Postpartum period, Pregnancy, Female, Low-income population
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOMCareBehavioural
8 sessions of brief interpersonal psychotherapy or medication management; maintenance sessions through 12 months postpartum.
| Study group | Role | What they receive |
|---|---|---|
| MOMCare intervention | Experimental | Depression care treatment with study depression care specialist (brief interpersonal psychotherapy or pharmacotherapy) Receives: Behavioral: MOMCare |
| Care Plus | No intervention | Usual care group; referral to community mental health treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCL-20 depression
Measured: baseline, 3, 6 12, 18 month follow-ups
Secondary outcomes (10)
Maternal health services utilization use and estimated costs
Measured: baseline, 3, 6 12, 18 month follow-ups
Pregnancy, delivery, birth outcomes
Measured: 6 month follow-up
Child services & outcomes (immunizations, well-child visits)
Measured: 6, 12, 18 month follow-ups
Depression free days & Quality Adjusted Life Years (EuroQol)
Measured: 3, 6, 12, 18 month follow-ups
Quality of depression care process
Measured: 3, 6, 12, 18 month follow-ups
Number of depression treatment sessions attended
Measured: 3, 6, 12, 18 month follow-ups
PHQ-9 depression
Measured: screening, baseline, 3, 6, 12, 18 month follow-ups
Edinburgh Postnatal Depression Scale
Measured: baseline, 3, 6, 12, 18 month follow-ups
Social Functioning (Work & Social Adjustment, Social & Leisure, Social Support)
Measured: baseline, 3, 6, 12, 18 month follow-ups
Inventory of Functional Status After Childbirth (IFSAC)
Measured: 6, 12, 18 month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Nancy Grote, University of Washington
- Investigators
- Nancy K Grote, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045655
- Sponsor's protocol ID
- R01MH084897
- Other IDs
- R01MH084897
- Acronym
- MOMCare
- Status last verified
- Jan 2016
- First submitted
- 8 Jan 2010
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26345179Jones 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.
PubMed 37146219Grote 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.
PubMed 28076671Grote 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.
PubMed 25016216
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- For Moms: Culturally Relevant Treatment Services for Perinatal Depression
- ClinicalTrials.gov ID
- NCT01045655
- Acronym / sponsor ID
- MOMCare / R01MH084897
- Conditions
- Depression
- Keywords
- Depression, Perinatal care, Postpartum period, Pregnancy, Female, Low-income population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOMCare intervention | Experimental | Behavioral: MOMCareDepression care treatment with study depression care specialist (brief interpersonal psychotherapy or pharmacotherapy) |
| Care Plus | No intervention | –Usual care group; referral to community mental health treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 or older
- pregnant: 12-32 weeks gestation
- able to speak English
- telephone access
- major depressive disorder or dysthymia
Key exclusion criteria (8 listed)
- currently in psychotherapy
- currently receiving pharmacotherapy from a psychiatrist
- high suicide risk
- history of bipolar disorder
- history of schizophrenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOMCare8 sessions of brief interpersonal psychotherapy or medication management; maintenance sessions through 12 months postpartum. | Behavioural | MOMCare intervention |
Primary outcome
SCL-20 depression
Time frame: baseline, 3, 6 12, 18 month follow-ups
10 secondary outcomes
Maternal health services utilization use and estimated costs
Time frame: baseline, 3, 6 12, 18 month follow-ups
Pregnancy, delivery, birth outcomes
Time frame: 6 month follow-up
Child services & outcomes (immunizations, well-child visits)
Time frame: 6, 12, 18 month follow-ups
Depression free days & Quality Adjusted Life Years (EuroQol)
Time frame: 3, 6, 12, 18 month follow-ups
Quality of depression care process
Time frame: 3, 6, 12, 18 month follow-ups
Number of depression treatment sessions attended
Time frame: 3, 6, 12, 18 month follow-ups
PHQ-9 depression
Time frame: screening, baseline, 3, 6, 12, 18 month follow-ups
Edinburgh Postnatal Depression Scale
Time frame: baseline, 3, 6, 12, 18 month follow-ups
Social Functioning (Work & Social Adjustment, Social & Leisure, Social Support)
Time frame: baseline, 3, 6, 12, 18 month follow-ups
Inventory of Functional Status After Childbirth (IFSAC)
Time frame: 6, 12, 18 month follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Results publication: PubMed 26345179Grote 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.
- Derived from this study: PubMed 37146219Jones 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.
- Derived from this study: PubMed 28076671Grote 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.
- Derived from this study: PubMed 25016216Grote 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy K Grote, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOMCare in people with Depression, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCL-20 depression (time frame: baseline, 3, 6 12, 18 month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01045655, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016.