Improving Outcomes for Low-Income Mothers With Depression
- Conditions
- Post Partum Depression
- Interventions
- Behavioral: Engagement-Focused Care Coordination (EFCC)Behavioral: Problem Solving Education (PSE)
- Registration Number
- NCT03221556
- Lead Sponsor
- Boston Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 231
- 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 receives Medicaid insurance
- Woman comfortable speaking and receiving information in English or Spanish
- Woman has no current source of mental health care
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Engagement-Focused Care Coordination (EFCC) Engagement-Focused Care Coordination (EFCC) The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services. Problem Solving Education (PSE) Problem Solving Education (PSE) The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist.
- Primary Outcome Measures
Name Time Method Depression Symptoms at 2 Months (QIDS SR-16 ≥ 11) 2 months Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Depression Symptoms at 4 Months (QIDS SR-16 ≥ 11) 4 months Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Depression Symptoms at 6 Months (QIDS SR-16 ≥ 11) 6 months Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Depression Symptoms at 8 Months (QIDS SR-16 ≥ 11) 8 months Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Depression Symptoms at 10 Months (QIDS SR-16 ≥ 11) 10 months Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Depression Symptoms at 12 Months (QIDS SR-16 ≥ 11) 12 months Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
- Secondary Outcome Measures
Name Time Method Anxiety Symptoms at 2 Months 2 months Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Anxiety Symptoms at 4 Months 4 months Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Anxiety Symptoms at 6 Months 6 months Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Anxiety Symptoms at 8 Months 8 months Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Anxiety Symptoms at 10 Months 10 months Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Anxiety Symptoms at 12 Months 12 months Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Engaged With Care at 2 Months 2 months Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Engaged With Care at 4 Months 4 months Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Engaged With Care at 6 Months 6 months Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Engaged With Care at 8 Months 8 months Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Engaged With Care at 10 Months 10 months Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Engaged With Care at 12 Months 12 months Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Parenting Behaviors at 6 Months 6 months Assessed by the Parenting Stress Index Short Form (PSI). This 36-item scale yields scores on three subscales - "parental distress", "parent-child dysfunctional interaction", and "difficult child" - which combine to form the total stress scale. Each item is scored 1-5 (1 = strongly agree; 5 = strongly disagree), yielding a scoring range of 36 to 180. Higher scores reflect more parent stress.
Parenting Behaviors at 12 Months 12 months Assessed by the Parenting Stress Index Short Form (PSI). This 36-item scale yields scores on three subscales - "parental distress", "parent-child dysfunctional interaction", and "difficult child" - which combine to form the total stress scale. Each item is scored 1-5 (1 = strongly agree; 5 = strongly disagree), yielding a scoring range of 36 to 180. Higher scores reflect more parent stress.
Coping With Stress at 6 Months 6 months Assessed by the Problem Focused Subscale of the Brief Coping Orientation to Problems Experienced Inventory (COPE). The overall COPE scale is a 28-item self-report measuring ways of coping with stress. Each item is scored 1-4 (1= I haven't been doing this at all; 4 = I've been doing this a lot). The Problem Focused Subscale includes 6 items focused on active coping, positive reframing, and planning. The scores for each question are added to total the subscale score, which ranges between 6-24 with lower scores indicating less problem-focused coping and higher scores indicating more problem focused coping.
Coping With Stress at 12 Months 12 months Assessed by the Problem Focused Subscale of the Brief COPE. The overall COPE scale is a 28-item self-report measuring ways of coping with stress. Each item is scored 1-4 (1= I haven't been doing this at all; 4 = I've been doing this a lot). The Problem Focused Subscale includes 6 items focused on active coping, positive reframing, and planning. The scores for each question are added to total the subscale score, which ranges between 6-24 with lower scores indicating less problem-focused coping and higher scores indicating more problem focused coping.
Behavioral Activation for Depression at 6 Months 6 months Assessed by the Behavioral Activation for Depression Scale (BADS). This 25-item self-reported measure is used to track changes weekly in the behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. The BADS subscales include activation, avoidance/rumination, work/school impairment, and social impairment. Each item is scored 0-6 (0=not at all; 6=completely), yielding a total score range of 0 to 150. High scores indicate greater levels of activation. For all the subscores, high scores are consistent with the subscale name.
Behavioral Activation for Depression at 12 Months 12 months Assessed by the Behavioral Activation for Depression Scale (BADS). This 25-item self-reported measure is used to track changes weekly in the behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. The BADS subscales include activation, avoidance/rumination, work/school impairment, and social impairment. Each item is scored 0-6 (0=not at all; 6=completely), yielding a total score range of 0 to 150. High scores indicate greater levels of activation. For all the subscores, high scores are consistent with the subscale name.
Trial Locations
- Locations (1)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States