Responsive e-Health Intervention for Perinatal Depression in Healthcare Settings (MMB)

October 10, 2023 updated by: Oregon Research Behavioral Intervention Strategies, Inc.
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
191

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60201
        • Northshore University Healthsystem
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Oregon Research Behavioral Intervention Strategies, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Treatment As Usual + MMB 2.0
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.
Behavioral: Treatment As Usual + MMB 2.0
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.
Other: Treatment As Usual Only
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.
Behavioral: Treatment As Usual Only
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Primary Health Questionnaire (PHQ-9)
Time Frame: Pretest (at enrollment) and posttest (3 months post enrollment)
The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options are on a 4-point scale (0 = not at all, 3 = nearly every day). The minimum overall score is 0 and the maximum overall score for the PHQ-9 is 27. Higher values represent more severe depression status.
Pretest (at enrollment) and posttest (3 months post enrollment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in General Anxiety Disorder (GAD)
Time Frame: Pretest (at enrollment) and posttest (3 months post enrollment)
The 7-item GAD measures generalized anxiety. Response options are on a 4-point scale (0 = did not apply to me, 3 = applied to me most of the time). A total sum score was computed. The minimum overall score is 0 and the maximum overall score is 21. Higher values represent more severe symptoms of generalized anxiety.
Pretest (at enrollment) and posttest (3 months post enrollment)
Change in Stress
Time Frame: Pretest (at enrollment) and posttest (3 months post enrollment)
The 7-item stress will measure generalized stress. Response options are on a 4-point response option (0 = did not apply to me, 3 = applied to me most of the time). A total sum score was computed. The minimum overall score is 0 and the maximum overall score is 21. Higher values represent more severe symptoms of generalized stress.
Pretest (at enrollment) and posttest (3 months post enrollment)
Change in Behavioral Activation for Depression Scale (BADS)
Time Frame: Pretest (at enrollment) and posttest (3 months post enrollment)
The 9-item BADS measures self-reports of activation, avoidance/rumination, work/school impairment, and social impairments. Response options are on a 7-point scale (0 = nota at all, 6 = completely) and a total sum score was computed. The minimum overall score is 0 and the maximum overall score is 54. Higher values represent more severe depression status related to behavioral activation.
Pretest (at enrollment) and posttest (3 months post enrollment)
Change in Self-Efficacy
Time Frame: Pretest (at enrollment) and posttest (3 months post enrollment)
The 8-item self-efficacy score measures confidence in one's ability to implement the skills taught in the program (e.g., how confident are you that you can increase your daily pleasant activities?). Response options are on 5-point scale (1 = not at all confident, , 5 = Very confident) and scores were averaged across the 8-items and can range from 1 to 5. A higher score indicates more self-efficacy to perform the tasks taught in the program.
Pretest (at enrollment) and posttest (3 months post enrollment)
Change in Automatic Thoughts Questionnaire - Short Form (ATQ)
Time Frame: Pretest (at enrollment) and posttest (3 months post enrollment)
The 8-item ATQ measures negative thoughts associated with depression. Response options are on a 4-point scale (0 = not at all, 3 = all the time) and a total mean score was computed and can range from 0 to 3. Higher values represent more severe depression status related to experiencing automatic thoughts.
Pretest (at enrollment) and posttest (3 months post enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Research Behavioral Intervention Strategies, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MH109191
  • 5R44MH109191-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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