N/A
N=231
Improving Outcomes for Low-Income Mothers With Depression
Post Partum Depression
Bottom Line
View on ClinicalTrials.gov: NCT03221556 ↗Enrolled (actual)
231
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Depression Symptoms at 2 Months (QIDS SR-16 ≥ 11) — 32; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Engagement-Focused Care Coordination (EFCC) (Behavioral); Problem Solving Education (PSE) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boston Medical Center
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression Symptoms at 2 Months (QIDS SR-16 ≥ 11) |
32; 26 | — |
| PRIMARY Depression Symptoms at 4 Months (QIDS SR-16 ≥ 11) |
29; 29 | — |
| PRIMARY Depression Symptoms at 6 Months (QIDS SR-16 ≥ 11) |
33; 29 | — |
| PRIMARY Depression Symptoms at 8 Months (QIDS SR-16 ≥ 11) |
34; 33 | — |
| PRIMARY Depression Symptoms at 10 Months (QIDS SR-16 ≥ 11) |
30; 32 | — |
| PRIMARY Depression Symptoms at 12 Months (QIDS SR-16 ≥ 11) |
34; 44 | — |
| SECONDARY Anxiety Symptoms at 2 Months |
9.9; 9.4 | — |
| SECONDARY Anxiety Symptoms at 4 Months |
10.2; 9.9 | — |
| SECONDARY Anxiety Symptoms at 6 Months |
10.9; 11.4 | — |
| SECONDARY Anxiety Symptoms at 8 Months |
10.2; 9.2 | — |
| SECONDARY Anxiety Symptoms at 10 Months |
9.8; 10.0 | — |
| SECONDARY Anxiety Symptoms at 12 Months |
10.5; 12.6 | — |
| SECONDARY Engaged With Care at 2 Months |
15; 13 | — |
| SECONDARY Engaged With Care at 4 Months |
19; 22 | — |
| SECONDARY Engaged With Care at 6 Months |
17; 22 | — |
| SECONDARY Engaged With Care at 8 Months |
17; 20 | — |
| SECONDARY Engaged With Care at 10 Months |
21; 24 | — |
| SECONDARY Engaged With Care at 12 Months |
22; 26 | — |
| SECONDARY Parenting Behaviors at 6 Months |
69.98; 76.93 | — |
| SECONDARY Parenting Behaviors at 12 Months |
72.92; 79.68 | — |
| SECONDARY Coping With Stress at 6 Months |
13.22; 13.66 | — |
| SECONDARY Coping With Stress at 12 Months |
12.39; 13.16 | — |
| SECONDARY Behavioral Activation for Depression at 6 Months |
93.62; 90.98 | — |
| SECONDARY Behavioral Activation for Depression at 12 Months |
95.21; 91.14 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03221556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.