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Behavioural Intervention

Text Messaging Intervention for Perinatal Depression (Perinatal TMI Trial)

N/A

Recruiting

Led By Kimberly Yonkers, MD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least age 16

Be younger than 65 years old

Must not have

Blind individuals

In a major depressive episode

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4 for pre-pilot and week 8 for pilot, adjusted for baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a text-based system that helps pregnant people reduce depression risk w/ tailored messages & evidence-based advice.

Who is the study for?

This trial is for English-speaking individuals at least 16 years old who are pregnant and at risk of depression, as indicated by certain screening scores or a history of depression during pregnancy. Participants must be willing to use a smartphone for text messages but not currently in mental health treatment, living in an institution, planning on terminating the pregnancy, or suffering from panic or substance use disorders.

What is being tested?

The study is testing a text messaging system designed to lower the risk of major depressive episodes in perinatal individuals. It includes tailored texts with links to resources based on Interpersonal Therapy and offers a peer chat feature. The goal is to see if this intervention can help prevent worsening symptoms of depression.

What are the potential side effects?

Since this trial involves receiving text messages rather than medication, traditional physical side effects are not expected. However, participants may experience emotional distress or discomfort related to discussing their feelings or receiving frequent communications about mental health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 16 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am legally blind.

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I am currently experiencing a major depressive episode.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4 for pre-pilot and week 8 for pilot, adjusted for baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4 for pre-pilot and week 8 for pilot, adjusted for baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 for pre-pilot and week 8 for pilot, adjusted for baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Edinburgh Prenatal Depression Scale

General Self Efficacy Scale

Patient engagement with chat

+2 more

Secondary study objectives

Diagnosis of a major depressive episode

Perlin Mastery Scale

User Engagement Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Text4MomsExperimental Treatment1 Intervention

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

Group II: Educational ControlActive Control1 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.

0 / 3Eligibility criteria met