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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a program called Calm Moms, which is designed to help pregnant Veterans who have experienced trauma and are dealing with feelings of anxiety, stress, or low mood. The program is web-based, meaning participants can access it online, and it uses techniques from cognitive behavioral therapy (CBT) that have been shown to be effective in improving mental health. The goal is to help these women feel better during their pregnancy, reduce their symptoms, and encourage them to seek further mental health support if needed.

To be eligible for this study, participants must be pregnant (in any trimester) and have experienced a traumatic event, along with showing signs of anxiety or depression. They should also have access to the internet and a device like a smartphone or computer to participate in the online program. It's important to note that pregnant Veterans can still take part even if they are receiving other treatments, like therapy or medication, as long as they do not have severe mental health issues that could prevent them from completing the program. This trial aims to gather important information about how well Calm Moms works and how it can be used in more places to help even more pregnant Veterans.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant (any trimester).
• • Endorse a DSM-5-TR Criterion A traumatic event as indexed by the trauma exposure portion of the PTSD screen for primary care (PC-PTSD-5).
• • Endorse clinically elevated anxiety (as indexed by a total score of \> 3 on the GAD-2) or depression symptoms (as indexed by a total score of \> 3 on the PHQ-2).
• • Able to participate in an online intervention (i.e., have internet and smartphone, tablet, or computer access).
• • Of note, pregnant Veterans will still be eligible if they are in concurrent psychotherapy and/or using psychotropic medications.
• Exclusion Criteria:
• • Evidence of a significant mental illness that would impede completion of the intervention (i.e., active psychosis, uncontrolled bipolar disorder, a severe alcohol/substance use disorder, or suicidal ideation or behavior that requires immediate hospitalization or treatment). Evidence of a significant mental illness will be determined via pre-enrollment chart review.