A Text Messaging Intervention to Reduce Perinatal Depression Risk

NCT06117397 | Completed

• 2 other identifiers: 00000462R34MH130934-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Episode

Outcome Measures

Primary Outcomes (5)

• Edinburgh Prenatal Depression Scale

  10-item continuous measure of depression. Self-report that will be administered by computer. Will be administered three times (for pre-pilot administered at screening, 2 weeks, and 4 weeks; for pilot administered at screening, 4 weeks, and 8 weeks). Items are scored 0-3, with a maximum score of 30. Higher scores show increased severity.

  Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline

• General Self Efficacy Scale

  10 item measure of self efficacy. Items are scored 1-4, with scores ranging between 10 and 40. A higher score indicates more self-efficacy. Will be administered three times (for pre-pilot administered at baseline, 2 weeks, and 4 weeks; for pilot administered at baseline, 4 weeks, and 8 weeks).

  Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline

• System Usability Scale

  10 items rated on a 1-5 scale, with scores ranging from 0-100, with a higher score indicating greater acceptability. Will be administered one times (for pre-pilot administered at 4 weeks; for pilot administered at 8 weeks).

  Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline

• Patient engagement with text messages

  Percentage of participants opening \>80% of text messages and clicking on \>30% of links to enhanced content.

  0-8 weeks

• Patient engagement with chat

  Percentage of participants engaging with chat and endorsing 4 out of 5 on its utility.

  0-8 weeks

Secondary Outcomes (3)

• Diagnosis of a major depressive episode

  Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline

• User Engagement Scale

  Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline

• Perlin Mastery Scale

  Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline

Study Arms (2)

Text4Moms

EXPERIMENTAL

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

Other: Text Messaging Intervention

Educational Control

NO INTERVENTION

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.

Interventions

Text Messaging Intervention OTHER

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

Text4Moms

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Worcester Polytechnic Institute: collaborator
• National Institute of Mental Health (NIMH): collaborator
• University of Massachusetts, Worcester: lead
• Yale University: collaborator
• Michigan State University: collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Study Officials

• Kimberly Yonkers, MD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: November 7, 2023
• Study Start: September 5, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after data analysis
• Access Criteria: interest in postpartum depression

Locations

US (1)