Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03221556
Other study ID # H-36434
Secondary ID AD-1603-34662
Status Completed
Phase N/A
First received
Last updated
Start date February 5, 2018
Est. completion date June 16, 2020

Study information

Verified date January 2021
Source Boston Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 231
Est. completion date June 16, 2020
Est. primary completion date June 16, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Engagement-Focused Care Coordination
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)
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.

Locations

Country Name City State
United States Boston Medical Center Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Boston Medical Center Boston University, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT03665038 - A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) Phase 3
Recruiting NCT06042972 - Risk of Maternal Depression From 1 Year to 4 Years Postpartum in Yvelines
Completed NCT04813341 - Effectiveness of Mat Pilates and Aerobic Training on Fatigue and Depression N/A
Terminated NCT04998565 - Add-on Effectiveness of EA or TENS in Early Postpartum Breast Engorgement N/A
Completed NCT04135612 - The Impact of a Daily Smartphone-based Communication Among Postpartum Women on Breastfeeding Rates N/A
Recruiting NCT05595486 - Baby2Home (B2H) Mobile Health Application N/A
Not yet recruiting NCT04516668 - Effect of Tele-consultation in Addition With Psychiatric Follow-up During COVID-19 in Women Who Have Medical History of Post-partum Depression
Completed NCT05215028 - Optimization of Mother-child Dyad Follow-up by a Multidomain Application: Real-world Cross Sectional Study
Recruiting NCT04129476 - Effect of a Cooperative Education Program Based on Precede-Proceed Model During Pregnancy on Postpartum Depression N/A
Recruiting NCT04193462 - Relationship-Based Intervention for Post-Partum Depression N/A
Completed NCT03638687 - Neuroimaging Epigenetics of Prospective Postpartum Depression Biomarkers
Active, not recruiting NCT03052374 - Video-Feedback Interaction Guidance for Improving Interactions Between Depressed Mothers and Their Infants ("VID-KIDS") N/A
Active, not recruiting NCT04940585 - ROSE in Sunset Park N/A
Terminated NCT04011592 - Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression Phase 2
Recruiting NCT05887115 - Nurse Family Partnership for Women With Previous Live Births N/A
Completed NCT04818047 - Adaptation and Pilot Testing of Web and Mobile Interface for the VID-KIDS Intervention N/A
Not yet recruiting NCT05643898 - "Mamá, te Entiendo" App-based Intervention for Reducing Depressive Symptoms in Postpartum Women N/A
Terminated NCT04264520 - Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women N/A
Recruiting NCT04845347 - A Wearable Morning Light Treatment for Postpartum Depression N/A
Not yet recruiting NCT06253676 - Sensing Technologies for Maternal Depression Treatment in Low-Resource Settings N/A