Major Depressive EpisodePTMINCT06117397
A Text Messaging Intervention to Reduce Perinatal Depression Risk
A study testing Text Messaging Intervention in people with Major Depressive Episode, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- Text Messaging Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
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).
Read the 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
- Being tested
- Text Messaging Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Messaging InterventionOther
A text messaging intervention that includes enhanced content such as tailoring, video links and a chat function
| Study group | Role | What they receive |
|---|---|---|
| Text4Moms | Experimental | Texts will include video links that reinforce information relevant to Interpersonal Psychotherapy (IPT). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 0-8 weeks
Patient engagement with chat
Percentage of participants engaging with chat and endorsing 4 out of 5 on its utility.
Measured: 0-8 weeks
Secondary outcomes (3)
Diagnosis of a major depressive episode
Diagnosis of a major depressive episode using the PHQ-9, the Major Depressive Disorder module of the full PHQ. 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).
Measured: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
User Engagement Scale
12 items rated on a 1-5 scale, with scores ranging from 10-50, with higher scores indicating greater acceptability, with an average score of 80.3. Will be administered one time (for pre-pilot administered at 4 weeks; for pilot administered at 8 weeks).
Measured: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
Perlin Mastery Scale
7 items scaled on a 1-4 scale, with scores ranging from 7-28. Low scores indicate low mastery. Will be administered one time at baseline.
Measured: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start5 Sep 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Michigan State University, Worcester Polytechnic Institute, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kimberly A. Yonkers, University of Massachusetts, Worcester
- Investigators
- Kimberly Yonkers, MD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117397
- Sponsor's protocol ID
- 00000462
- Other IDs
- R34MH130934-03
- Acronym
- PTMI
- Status last verified
- Jan 2026
- First submitted
- 1 May 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We welcome any interest in using or modifying the intervention materials developed under this project, which will be aided by our use of the Computerized Intervention Authoring System (CIAS) platform. Our overall plan will include presentations at national scientific meetings as well as publication of results, via reputable peer-reviewed journals and the National Library of Medicine/PubMed Central. We will deposit this dataset with the National Database for Clinical Trials Related to Mental Illness. We will indicate in publications and presentations where and how to access these data. Study materials and information regarding access to intervention content will be made available via the Open Science Framework (OSF). Individuals who would like our data can also complete a "data analysis requisition form" that describes their specific hypotheses with mock-ups of tables. All data will be de-identified before sharing. We will make the data available under a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Text Messaging Intervention to Reduce Perinatal Depression Risk
- ClinicalTrials.gov ID
- NCT06117397
- Acronym / sponsor ID
- PTMI / 00000462
- Conditions
- Major Depressive Episode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Yale University, Michigan State University, Worcester Polytechnic Institute, National Institute of Mental Health (NIMH)
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text4Moms | Experimental | Other: Text Messaging InterventionTexts will include video links that reinforce information relevant to Interpersonal Psychotherapy (IPT). |
| 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. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- In a major depressive episode
- Planning on terminating pregnancy
- Have panic disorder or substance use disorder
- Currently in behavioral health care treatment
- Blind individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Messaging InterventionA text messaging intervention that includes enhanced content such as tailoring, video links and a chat function | Other | Text4Moms |
Primary outcome
Edinburgh Prenatal Depression Scale
Time frame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
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.
General Self Efficacy Scale
Time frame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
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).
System Usability Scale
Time frame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
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).
Patient engagement with text messages
Time frame: 0-8 weeks
Percentage of participants opening >80% of text messages and clicking on >30% of links to enhanced content.
Patient engagement with chat
Time frame: 0-8 weeks
Percentage of participants engaging with chat and endorsing 4 out of 5 on its utility.
3 secondary outcomes
Diagnosis of a major depressive episode
Time frame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
User Engagement Scale
Time frame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
Perlin Mastery Scale
Time frame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Yes. We welcome any interest in using or modifying the intervention materials developed under this project, which will be aided by our use of the Computerized Intervention Authoring System (CIAS) platform. Our overall plan will include presentations at national scientific meetings as well as publication of results, via reputable peer-reviewed journals and the National Library of Medicine/PubMed Central. We will deposit this dataset with the National Database for Clinical Trials Related to Mental Illness. We will indicate in publications and presentations where and how to access these data. Study materials and information regarding access to intervention content will be made available via the Open Science Framework (OSF). Individuals who would like our data can also complete a "data analysis requisition form" that describes their specific hypotheses with mock-ups of tables. All data will be de-identified before sharing. We will make the data available under a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Yonkers, MD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging Intervention in people with Major Depressive Episode, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Prenatal Depression Scale (time frame: Week 4 for pre-pilot and week 8 for pilot, adjusted for baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.