Clinical trial NCT03995316: Responsive e-Health Intervention for Perinatal Depression in Healthcare Settings
Official title: Responsive e-Health Intervention for Perinatal Depression in Healthcare Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-06-24
Enrollment: 191
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-Arm random control trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: Perinatal depression (experienced by at least 14-20% of pregnant and postpartum women) is recognized as the most common complication of childbirth and as having extremely serious consequences, including significant suffering for pregnant women/new mothers and their families, and adverse impacts on infant development. Unfortunately, there are many barriers that make it difficult for women with perinatal depression to access clinic-based mental health treatments, and participation is low. Treatment uptake is limited by psychological barriers (stigma, feelings of failure, and embarrassment); knowledge barriers (poor understanding about impact of perinatal depression on infant health, uncertainty about where to get treatment); infrastructure barriers (fear of negative judgment from care providers, avoidance of prescription medications while breastfeeding); physical barriers in rural settings (too few care providers, unacceptable logistical demands on time, transportation, and childcare); and provider-level barriers (inadequate skills, fear of liability, dearth of treatment options, and inadequate reimbursement). To address this need, investigators obtained funding (National Institutes of Health (NIH) R01MH084931) to develop and test the MomMoodBooster program (MMB), an innovative Web-based program for treating postpartum depression (PPD). Based on cognitive behavioral therapy (CBT) and incorporating multimedia modeling and engaging activities, MMB is designed to enable women to identify patterns in their thoughts and behaviors and to develop a personal action plan to make helpful changes. MMB also has an administrative website designed for use by both project managers and supportive phone coaches to monitor the overall progress of participants. In our Small Business Innovation Research (SBIR) Phase I grant (R43MH109191), the investigators began a redesign of MMB so that it could be used more effectively as a product for delivering PPD treatment by practical healthcare delivery organizations. Specifically, the investigators enhanced the underlying database architecture (and the related administration website interface) to make it easier for multiple organizations in multiple settings to use MMB. In our proposed SBIR Phase II, the investigators propose to complete the process of making a commercial-ready product (MMB 2.0) that fits the workflow and staffing of healthcare organizations. Specifically, the investigators propose to finish the enhancement of the database architecture and its administrative site, to expand MMB to include prenatal as well as postpartum depressed women, and to deliver MMB using a new responsive design technology so that women will be able to use it interchangeably with any internet-accessible computer device (desktop, laptop, tablet, smart-phone). Finally, the investigators plan to use a 2-arm randomized controlled trial to evaluate the efficacy of MMB 2.0 compared to treatment as usual in a large healthcare setting.

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

Primary outcomes:
measure: Change in Primary Health Questionnaire (PHQ-9)
timeFrame: Pretest (at enrollment) and posttest (3 months post enrollment)
Secondary outcomes:
measure: Change in General Anxiety Disorder (GAD)
timeFrame: Pretest (at enrollment) and posttest (3 months post enrollment)
measure: Change in Stress
timeFrame: Pretest (at enrollment) and posttest (3 months post enrollment)
measure: Change in Behavioral Activation for Depression Scale (BADS)
timeFrame: Pretest (at enrollment) and posttest (3 months post enrollment)
measure: Change in Automatic Thoughts Questionnaire - Short Form (ATQ)
timeFrame: Pretest (at enrollment) and posttest (3 months post enrollment)
measure: Change in Self-Efficacy
timeFrame: Pretest (at enrollment) and posttest (3 months post enrollment)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Springfield
country: United States
facility: Oregon Research Behavioral Intervention Strategies, Inc.
state: Oregon
Study officials:
References: