Clinical trial NCT03221556: Improving Outcomes for Low-Income Mothers With Depression
Official title: Improving Outcomes for Low-Income Mothers With Depression: A Comparative Effectiveness Trial of Two Brief Interventions in the Patient-Centered Medical Home.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Partum Depression
Keywords: Comparative effectiveness research
Patient-centered medical home
Shared decision-making
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Boston University
First posted: 2017-07-18
Enrollment: 231
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a randomized comparative effectiveness trial to improve outcomes among pregnant and post-partum women with symptoms of depression. Both interventions under study will be based in the patient-centered medical home setting at Boston Medical Center - specifically, in prenatal clinic or in the general pediatrics clinic. The study is a type 1 hybrid effectiveness-implementation trial of 230 mothers with clinically significant depressive symptomatology. Of the 230 subjects, half will receive the Engagement-Focused Care Coordination intervention; the other half will receive the Problem Solving Education intervention. Outcomes for mothers will be assessed every 2 months throughout a 12 month follow-up period. This trial is funded by a contract with PCORI, the Patient-Centered Outcomes Research Institute.

Detailed description: This is a type 1 hybrid effectiveness-implementation trial of 230 mothers with clinically significant depressive symptomatology being conducted at Boston Medical Center (BMC). The effectiveness component of the study (which is the trial registered on ClinicalTrials.gov) is a pragmatic, parallel group randomized trial that measures patient-reported outcomes over 12 months of follow-up. The implementation portion comprises a series of qualitative interviews to discern barriers and facilitators to intervention implementation.

The investigators will enroll 230 mothers with clinically significant depressive symptomatology according to the Edinburgh Postnatal Depression Scale (EPDS), a widely used screening instrument valid during pregnancy and in the postpartum period.

Engagement-Focused Care Coordination will be compared to Problem Solving Education (PSE). Whereas Engagement-Focused Care Coordination emphasizes referral to formal depression services following a brief engagement session, PSE offers initial depression treatment onsite, followed by referral to further care if depressive symptoms persist or worsen. Patients in both arms will have access to the same array of community-based mental health services upon referral. Both intervention arms are designed to be peer-delivered; thus, the investigators will enlist their existing team of PCMH family advocates - a group of women (approximately age-matched with our study participants) - to serve as intervention providers. To minimize contamination across comparators, this team will be divided into those trained in Engagement Interviewing and those trained in PSE.

Eligibility criteria: Inclusion Criteria:

* Woman is pregnant and receives prenatal care at BMC; or is biological mother of 0 to 18-month-old child receiving care at BMC pediatric primary care clinic
* Woman has EPDS score ≥ 10
* Woman comfortable speaking and receiving information in English or Spanish
* Woman has no current source of mental health care, defined as having no more than one mental health care appointment in the last 3 months; OR, if more than one appointment, woman has no upcoming appointment

Exclusion Criteria:

* Woman under 18 years of age
* Woman endorses suicidality
* Woman exhibits signs of psychosis or is cognitively limited\*

  * As part of the informed consent process, we will administer the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), which has been validated in populations of depressed and schizophrenic adults

Primary outcomes:
measure: Depression Symptoms at 2 Months (QIDS SR-16 ≥ 11)
timeFrame: 2 months
measure: Depression Symptoms at 4 Months (QIDS SR-16 ≥ 11)
timeFrame: 4 months
measure: Depression Symptoms at 6 Months (QIDS SR-16 ≥ 11)
timeFrame: 6 months
measure: Depression Symptoms at 8 Months (QIDS SR-16 ≥ 11)
timeFrame: 8 months
measure: Depression Symptoms at 10 Months (QIDS SR-16 ≥ 11)
timeFrame: 10 months
measure: Depression Symptoms at 12 Months (QIDS SR-16 ≥ 11)
timeFrame: 12 months
Secondary outcomes:
measure: Anxiety Symptoms at 2 Months
timeFrame: 2 months
measure: Anxiety Symptoms at 4 Months
timeFrame: 4 months
measure: Anxiety Symptoms at 6 Months
timeFrame: 6 months
measure: Anxiety Symptoms at 8 Months
timeFrame: 8 months
measure: Anxiety Symptoms at 10 Months
timeFrame: 10 months
measure: Anxiety Symptoms at 12 Months
timeFrame: 12 months
measure: Engaged With Care at 2 Months
timeFrame: 2 months
measure: Engaged With Care at 4 Months
timeFrame: 4 months
measure: Engaged With Care at 6 Months
timeFrame: 6 months
measure: Engaged With Care at 8 Months
timeFrame: 8 months
measure: Engaged With Care at 10 Months
timeFrame: 10 months
measure: Engaged With Care at 12 Months
timeFrame: 12 months
measure: Parenting Behaviors at 6 Months
timeFrame: 6 months
measure: Parenting Behaviors at 12 Months
timeFrame: 12 months
measure: Coping With Stress at 6 Months
timeFrame: 6 months
measure: Coping With Stress at 12 Months
timeFrame: 12 months
measure: Behavioral Activation for Depression at 6 Months
timeFrame: 6 months
measure: Behavioral Activation for Depression at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Michael Silverstein, MD MPH
role: STUDY_DIRECTOR
References: