A Text Messaging Intervention to Reduce Perinatal Depression Risk

NCT ID: NCT06117397

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-05
• Study Completion Date: 2025-12-01

Brief Summary

Development and preliminary testing of a text messaging intervention that will reduce the risk of a major depressive episode and worsening depressive symptoms in perinatal individuals. The system will screen pregnant individuals, send tailored text messages with links to enhanced content, and will include a peer chat function.This accessible text platform will leverage both the ease of use inherent in text messages and the power of enhanced content drawn evidence from based behavioral interventions (Interpersonal Therapy).

Detailed Description

About 1 in 7 pregnant individuals experience depression, with roughly the same number facing this devastating illness after delivery. The downstream effects of perinatal depression adds to its toll with increased risk of preterm birth; impairments in maternal-child attachment; adverse effects on infant development; and decreased breastfeeding initiation/duration. The US Preventative Services Task Force finds that some major depressive episodes (MDEs) can be averted with counseling strategies that employ principles from interpersonal therapy (IPT). They also observe the value of peer support, which can decrease perinatal depression. A possible shared mechanism for these interventions is enhancement of self-efficacy, which is critical in the setting of stressful events such as pregnancy and parenting. However, practical implementation of interventions to reduce depression risk is challenging. Reproductive health providers have limited time and training to deliver depression prevention programs. As well, perinatal individuals may not appreciate the need to participate in a prevention program or have difficulty finding or affording providers of behavioral interventions. Technology can assist with these challenges by providing education, support and therapeutic interventions to perinatal individuals. Unlike web-based applications (apps), text messaging interventions (TMIs) can proactively deliver health information and messages, even to those with limited motivation to engage in preventative interventions. Mobile phone use has exploded with >95% of pregnant individuals (including >85% of the minority population) reporting use of a mobile phone to communicate via short text messages. TMIs can also screen perinatal individuals for depression outside the general medical setting and provide general peer support. With end-user input throughout the process, the investigators will build a multi-component TMI (called Text4Moms) that screens and triages perinatal individuals for risk of a MDE. This system will draw content from IPT; it will send tailored text messages with links to relevant video content to perinatal individuals at risk for a depressive episode. An on-demand secure chat function staffed by a peer with lived experience will complement the text messages for enhanced support. The system will include pre-populated content for peers to cut and paste into text messages for participants, which will support peers and decrease their training burden. This system leverages some of the best components of an app (video, tailoring, chat) into a common and user-friendly text messaging platform. After development, the investigators will conduct a pilot randomized trial to test the ability of the TMI to enhance the target of self-efficacy and decrease depressive symptoms and risk of a MDE. The investigators will query Research Domain Criteria (RDOC) constructs of "loss" and "threat," and will evaluate preliminary effectiveness and implementation (assessment of feasibility, acceptability, use and benefit of the peer chat feature) through a pilot randomized clinical trial.

Conditions

Major Depressive Episode

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Text4Moms

Texts will include video links that reinforce information relevant to Interpersonal Psychotherapy (IPT).

Group Type: EXPERIMENTAL

Text Messaging Intervention

Intervention Type: OTHER

A text messaging intervention that includes enhanced content such as tailoring, video links and a chat function

Educational Control

The control condition will be limited to texts related to pregnancy, nutrition and sleep. We will avoid elements that have behavioral therapeutic effects. Although this condition is meant to constitute time and attention control, we will include material on recognizing depression and links to ways to attain depression treatment and suicide hotline information.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Text Messaging Intervention

A text messaging intervention that includes enhanced content such as tailoring, video links and a chat function

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• English speaking
• "At risk" as determined by an Edinburgh Postnatal Depression Scale score of at least 9, or an average score >3 on the 6-item Medical Outcomes Social Support Survey or history of depression in pregnancy or postpartum depression
• At least age 16
• Are willing and able to provide informed consent
• Are willing to use a smart phone to receive texts

Exclusion Criteria

• In a major depressive episode
• Planning on terminating pregnancy
• Have panic disorder or substance use disorder
• Currently in behavioral health care treatment
• Blind individuals
• Permanently living in an institutional setting

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

Michigan State University

OTHER

Sponsor Role: collaborator

Worcester Polytechnic Institute

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Kimberly A. Yonkers

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly Yonkers, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Chan Medical School

Locations

UMass Chan Medical School

Worcester, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R34MH130934-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00000462

Identifier Type: -

Identifier Source: org_study_id