Improving Outcomes for Low-Income Mothers With Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Outcomes for Low-Income Mothers With Depression: A Comparative Effectiveness Trial of Two Brief Interventions in the Patient-Centered Medical Home.

Conditions
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Post Partum Depression

Intervention / Treatment
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* Behavioral: Engagement-Focused Care Coordination
* Behavioral: Problem Solving Education (PSE)


Participation Criteria
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Eligibility Criteria
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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 receives Medicaid insurance Woman comfortable speaking and receiving information in English or Spanish Woman has no current source of mental health care 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Engagement-Focused Care Coordination<br>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. | Behavioral: Engagement-Focused Care Coordination<br>* Engagement interviewing is embedded within a traditional PCMH structure using motivational interviewing and shared decision making; it explores treatment options in the context of a patient's life circumstances, and helps her work through ambivalence to receiving care. In one to two sessions, providers disclose the probable diagnosis of depression, provide psycho-education, present treatment options, and engage clients in shared decision making to determine the most appropriate referral.<br>|
| Active Comparator: Problem Solving Education (PSE)<br>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. | Behavioral: Problem Solving Education (PSE)<br>* Problem solving sessions are one-on-one, workbook-based interactions. Sessions comprise seven sequential steps: 1-defining a problem, 2-establishing goals for problem resolution, 3-generating multiple solution alternatives, 4-Implementing decision making guidelines, 5-evaluating and choosing solutions, 6-Implementing the preferred solutions, and 7-evaluating the outcome.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Symptoms | 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. Because of its wide scoring range, the QIDS can be used to detect depressive illness in populations with low symptoms. Lower scores reflect less depressive symptoms. | 2 months | 
| Depression Symptoms | 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. Because of its wide scoring range, the QIDS can be used to detect depressive illness in populations with low symptoms. Lower scores reflect less depressive symptoms. | 4 months | 
| Depression Symptoms | 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. Because of its wide scoring range, the QIDS can be used to detect depressive illness in populations with low symptoms. Lower scores reflect less depressive symptoms. | 6 months | 
| Depression Symptoms | 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. Because of its wide scoring range, the QIDS can be used to detect depressive illness in populations with low symptoms. Lower scores reflect less depressive symptoms. | 8 months | 
| Depression Symptoms | 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. Because of its wide scoring range, the QIDS can be used to detect depressive illness in populations with low symptoms. Lower scores reflect less depressive symptoms. | 10 months | 
| Depression Symptoms | 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. Because of its wide scoring range, the QIDS can be used to detect depressive illness in populations with low symptoms. Lower scores reflect less depressive symptoms. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Symptoms | 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. | 2 months | 
| Anxiety Symptoms | 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. | 4 months | 
| Anxiety Symptoms | 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. | 6 months | 
| Anxiety Symptoms | 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. | 8 months | 
| Anxiety Symptoms | 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. | 10 months | 
| Anxiety Symptoms | 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. | 12 months | 
| Parenting behaviors | 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. | 6 months | 
| Parenting behaviors | 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. | 12 months | 
| Child Behavior | Assessed by the Child Behavior Checklist (CBCL-1.5/5). This 99-item scale assesses a range of internalizing and externalizing child behaviors for children 1.5-5 years. 67 items are scored on the following syndrome scales: Emotionally Reactive, Anxious/Depressed, Somatic Complaints, Withdrawn, Attention Problems, Aggressive Behavior, and Sleep Problems. 32 items are scored on the following DSM-oriented scales: Affective Problems, Anxiety Problems, Pervasive Developmental Problems, Attention Deficit/Hyperactivity Problems, Stress Problems, Autism Spectrum Problems, and Oppositional Defiant Problems. Each item is scored 0-2 (0 = not true; 2 = very/often true), and one item is added by the parent/caregiver, yielding a total score range of 0 to 200. Lower scores are more favorable. | 6 months | 
| Child Behavior | Assessed by the Child Behavior Checklist (CBCL-1.5/5). This 99-item scale assesses a range of internalizing and externalizing child behaviors for children 1.5-5 years. 67 items are scored on the following syndrome scales: Emotionally Reactive, Anxious/Depressed, Somatic Complaints, Withdrawn, Attention Problems, Aggressive Behavior, and Sleep Problems. 32 items are scored on the following DSM-oriented scales: Affective Problems, Anxiety Problems, Pervasive Developmental Problems, Attention Deficit/Hyperactivity Problems, Stress Problems, Autism Spectrum Problems, and Oppositional Defiant Problems. Each item is scored 0-2 (0 = not true; 2 = very/often true), and one item is added by the parent/caregiver, yielding a total score range of 0 to 200. Lower scores are more favorable. | 12 months | 
| Engagement and Retention with Mental Health Services | Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care. | 2 months | 
| Engagement and Retention with Mental Health Services | Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care. | 4 months | 
| Engagement and Retention with Mental Health Services | Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care. | 6 months | 
| Engagement and Retention with Mental Health Services | Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care. | 8 months | 
| Engagement and Retention with Mental Health Services | Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care. | 10 months | 
| Engagement and Retention with Mental Health Services | Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care. | 12 months | 
| Coping with Stress | Assessed by the Brief COPE. This scale is a 28-item self-report measuring ways of coping with stress on 14 subscales - self-distraction, active coping, denial, substance use, emotional support, use of informational support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. Each item is scored 1-4 (1= I haven't been doing this at all; 4 = I've been doing this a lot). There is no such thing as an overall score on this measure. | 6 months | 
| Coping with Stress | Assessed by the Brief COPE. This scale is a 28-item self-report measuring ways of coping with stress on 14 subscales - self-distraction, active coping, denial, substance use, emotional support, use of informational support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. Each item is scored 1-4 (1= I haven't been doing this at all; 4 = I've been doing this a lot). There is no such thing as an overall score on this measure. | 12 months | 
| Behavioral Activation for Depression | 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. | 6 months | 
| Behavioral Activation for Depression | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comparative effectiveness research, Patient-centered medical home, Shared decision-making