Improving Outcomes for Low-Income Mothers With Depression

NCT03221556 | Completed Results DMC

• 2 other identifiers: H-36434AD-1603-34662
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Partum Depression

Keywords

Comparative effectiveness research; Patient-centered medical home; Shared decision-making

Outcome Measures

Primary Outcomes (6)

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

  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 months

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

  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 months

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

  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 months

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

  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.

  8 months

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

  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.

  10 months

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

  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.

  12 months

Secondary Outcomes (18)

• Anxiety Symptoms at 2 Months

  2 months

• Anxiety Symptoms at 4 Months

  4 months

• Anxiety Symptoms at 6 Months

  6 months

• Anxiety Symptoms at 8 Months

  8 months

• Anxiety Symptoms at 10 Months

  10 months

Study Arms (2)

Engagement-Focused Care Coordination (EFCC)

ACTIVE COMPARATOR

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 (EFCC)

Problem Solving Education (PSE)

ACTIVE COMPARATOR

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)

Interventions

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.

Engagement-Focused Care Coordination (EFCC)

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.

Problem Solving Education (PSE)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Boston University: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• Elansary M, Kistin CJ, Antonio J, Fernandez-Pastrana I, Lee-Parritz A, Cabral H, Miller ES, Silverstein M. Effect of Immediate Referral vs a Brief Problem-solving Intervention for Screen-Detected Peripartum Depression: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2313151. doi: 10.1001/jamanetworkopen.2023.13151.

  PMID: 37171819 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Caroline Kistin, MD MSc
• Organization: Boston Medical Center

caroline_kistin@brown.edu

(617) 414-3638

Study Officials

• Michael Silverstein, MD MPH

  Boston University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 18, 2017
• Study Start: February 5, 2018
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: This will become available approximately one year after the conclusion of the project. We will make the data available indefinitely.
• Access Criteria: Access will be determined by the BU Center for Clinical Translational Epidemiology and Comparative Effectiveness Research.

Locations

US (1)