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Completed

NCT Number: NCT03221556

Improving Outcomes for Low-Income Mothers With Depression

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.

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Key information

Conditions

Post Partum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Engagement-Focused Care Coordination (EFCC)

Behavioral

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.

Problem Solving Education (PSE)

Behavioral

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.

Primary outcomes

  1. Depression Symptoms at 2 Months (QIDS SR-16 ≥ 11)

    Time frame: 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.

  2. Depression Symptoms at 4 Months (QIDS SR-16 ≥ 11)

    Time frame: 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.

  3. Depression Symptoms at 6 Months (QIDS SR-16 ≥ 11)

    Time frame: 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.

  4. Depression Symptoms at 8 Months (QIDS SR-16 ≥ 11)

    Time frame: 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.

  5. Depression Symptoms at 10 Months (QIDS SR-16 ≥ 11)

    Time frame: 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.

  6. Depression Symptoms at 12 Months (QIDS SR-16 ≥ 11)

    Time frame: 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 outcomes

  1. Anxiety Symptoms at 2 Months

    Time frame: 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.

  2. Anxiety Symptoms at 4 Months

    Time frame: 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.

  3. Anxiety Symptoms at 6 Months

    Time frame: 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.

  4. Anxiety Symptoms at 8 Months

    Time frame: 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.

  5. Anxiety Symptoms at 10 Months

    Time frame: 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.

  6. Anxiety Symptoms at 12 Months

    Time frame: 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.

  7. Engaged With Care at 2 Months

    Time frame: 2 months

    Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.

  8. Engaged With Care at 4 Months

    Time frame: 4 months

    Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.

  9. Engaged With Care at 6 Months

    Time frame: 6 months

    Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.

  10. Engaged With Care at 8 Months

    Time frame: 8 months

    Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.

  11. Engaged With Care at 10 Months

    Time frame: 10 months

    Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.

  12. Engaged With Care at 12 Months

    Time frame: 12 months

    Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.

  13. Parenting Behaviors at 6 Months

    Time frame: 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.

  14. Parenting Behaviors at 12 Months

    Time frame: 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.

  15. Coping With Stress at 6 Months

    Time frame: 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.

  16. Coping With Stress at 12 Months

    Time frame: 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.

  17. Behavioral Activation for Depression at 6 Months

    Time frame: 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.

  18. Behavioral Activation for Depression at 12 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Boston University
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 18, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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