N/A
Completed N=191
Responsive e-Health Intervention for Perinatal Depression in Healthcare Settings
Source: ClinicalTrials.gov NCT03995316 ↗Enrolled (actual)
191
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Change in Primary Health Questionnaire (PHQ-9) — 10.68; 10.24; 5.78; 7.48 score on a scale — p=.003
Summary
Perinatal depression is experienced by at least 14-20% of pregnant and postpartum women, and is recognized as the most common complication of childbirth. In this project, the investigators plan to complete the process of making MomMoodBooster (MMB), a web-based cognitive-behavioral depression intervention, into a commercial ready product, MMB 2.0, that fits the workflow and staffing of healthcare organizations and is designed for both prenatal and postpartum women who are depressed. The investigators will also conduct a 2-arm randomized controlled trial to evaluate the efficacy of treatment as usual plus MMB 2.0 compared to treatment as usual in a large healthcare setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Primary Health Questionnaire (PHQ-9) |
10.68; 10.24; 5.78; 7.48 | .003 sig |
| SECONDARY Change in General Anxiety Disorder (GAD) |
5.23; 5.96; 2.81; 4.12 | .283 |
| SECONDARY Change in Stress |
9.61; 10.36; 5.79; 8.10 | .019 sig |
| SECONDARY Change in Behavioral Activation for Depression Scale (BADS) |
25.15; 24.46; 31.15; 29.37 | .440 |
| SECONDARY Change in Automatic Thoughts Questionnaire - Short Form (ATQ) |
1.23; 1.24; 0.72; 0.90 | .055 |
| SECONDARY Change in Self-Efficacy |
2.86; 2.77; 3.40; 3.05 | .041 sig |
Eligibility Criteria
Inclusion Criteria
- pregnant or postpartum
- have elevated Edinburgh Postnatal Depression Scale (EPDS) of ≥ 12
- access to broadband internet and a computer at home (desktop, laptop, tablet) or a smartphone (iOS or Android)
- English language proficiency sufficient to enable completion of the informed consent and to engage in all study activities that are delivered in English
Exclusion Criteria
- Women assessed with active suicidal ideation will be excluded and provided with immediate psychiatric care consistent with NorthShore's established safety protocol
Data sourced from ClinicalTrials.gov (NCT03995316). 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. Informational only — not medical advice.