Actively Recruiting

Phase Not Applicable
FEMALE
NCT06906185

Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans

Led by VA Office of Research and Development · Updated on 2026-05-07

36

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The current proposal aims to refine and examine an intervention called Calm Moms. Calm Moms is a web-based treatment program designed to reduce anxiety, stress, and low mood symptoms among pregnant Veterans with a history of trauma exposure. Its contents are based on empirically supported cognitive behavioral therapy (CBT) techniques shown to be effective in reducing these symptoms. Further, the Calm Moms program is tailored towards the unique concerns of pregnant women and incorporates information on how to cope with and reduce the impact of trauma. Calm Moms may benefit pregnant Veterans by reducing their anxiety, stress, and low mood symptoms. Additionally, pregnant Veterans who engage in Calm Moms may have improved functioning, reduced impairment during pregnancy, and show increased interest and engagement with additional mental health care. The current proposal also aims to collect information regarding implementation of Calm Moms at additional sites, which will allow Calm Moms to impact a larger group of pregnant Veterans.

CONDITIONS

Official Title

Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant (any trimester)
  • Experienced a traumatic event meeting DSM-5-TR Criterion A as identified by PTSD screening
  • Have clinically elevated anxiety or depression symptoms indicated by screening scores
  • Have access to the internet and a smartphone, tablet, or computer to participate online
  • May be receiving psychotherapy or using psychotropic medications during the study
Not Eligible

You will not qualify if you...

  • Presence of significant mental illness that would prevent completing the intervention
  • Active psychosis
  • Uncontrolled bipolar disorder
  • Severe alcohol or substance use disorder
  • Suicidal thoughts or behavior requiring immediate hospitalization or treatment
  • Mental illness status confirmed by pre-enrollment chart review

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Southeast Louisiana Veterans Health Care System, New Orleans, LA

New Orleans, Louisiana, United States, 70119

Actively Recruiting

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Research Team

M

Mary E Shapiro, PhD MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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