Responsive e-Health Intervention for Perinatal Depression in Healthcare Settings

NCT03995316 | Completed Results

• 2 other identifiers: MH1091915R44MH109191-03
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 2

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.

Conditions

Perinatal Depression

Outcome Measures

Primary Outcomes (1)

• Change in Primary Health Questionnaire (PHQ-9)

  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 Outcomes (5)

• Change in General Anxiety Disorder (GAD)

  Pretest (at enrollment) and posttest (3 months post enrollment)

• Change in Stress

  Pretest (at enrollment) and posttest (3 months post enrollment)

• Change in Behavioral Activation for Depression Scale (BADS)

  Pretest (at enrollment) and posttest (3 months post enrollment)

• Change in Automatic Thoughts Questionnaire - Short Form (ATQ)

  Pretest (at enrollment) and posttest (3 months post enrollment)

• Change in Self-Efficacy

  Pretest (at enrollment) and posttest (3 months post enrollment)

Study Arms (2)

Treatment As Usual + MMB 2.0

OTHER

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

Treatment As Usual Only

OTHER

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

Interventions

Treatment As Usual + MMB 2.0 BEHAVIORAL

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 + MMB 2.0

Treatment As Usual Only BEHAVIORAL

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.

Treatment As Usual Only

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women assessed with active suicidal ideation will be excluded and provided with immediate psychiatric care consistent with NorthShore's established safety protocol

Sponsors & Collaborators

• Oregon Research Behavioral Intervention Strategies, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

NorthShore University HealthSystem

Chicago, Illinois, 60201, United States

Location

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, 97477, United States

Location

Related Publications (1)

• Danaher BG, Seeley JR, Silver RK, Tyler MS, Kim JJ, La Porte LM, Cleveland E, Smith DR, Milgrom J, Gau JM. Trial of a patient-directed eHealth program to ameliorate perinatal depression: the MomMoodBooster2 practical effectiveness study. Am J Obstet Gynecol. 2023 Apr;228(4):453.e1-453.e10. doi: 10.1016/j.ajog.2022.09.027. Epub 2022 Sep 26.

  PMID: 36174746 DERIVED

MeSH Terms

Interventions

Therapeutics

Results Point of Contact

• Title: David Smith
• Organization: Oregon Research Behavior Intervention Strategies, Inc. dba Influents Innovations

david.smith@influetnsin.com

541-484-2123

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2-Arm random control trial

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 24, 2019
• Study Start: August 24, 2018
• Primary Completion: May 31, 2021
• Study Completion: July 31, 2021
• Last Updated: October 12, 2023
• Results First Posted: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)