CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 191 enrolled
Drug / intervention
Treatment As Usual + MMB 2.0 +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03995316
NCT03995316N/ACompleted

Responsive e-Health Intervention for Perinatal Depression in Healthcare Settings

Oregon Research Behavioral Intervention Strategies, Inc.·interventional·Posted Jun 24, 2019·Updated Oct 12, 2023

In Brief

A clinical study evaluating Treatment As Usual + MMB 2.0 and Treatment As Usual Only for Perinatal Depression. Completed, enrolled 191 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 24, 2019
Enrollment StartAug 24, 2018
Primary CompletionMay 31, 2021
Study CompletionJul 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.0 years ago

Interventions

Treatment As Usual + MMB 2.0behavioral

Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program.

Treatment As Usual Onlybehavioral

NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals.