RecruitingNot ApplicableNCT06906185

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

Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans (CDA 22-135)


Sponsor

VA Office of Research and Development

Enrollment

36 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is adapting and testing an online trauma-informed treatment program for pregnant veterans who have experienced traumatic events and are also dealing with anxiety or depression — helping them manage mental health symptoms remotely during pregnancy. **You may be eligible if...** - You are currently pregnant (any trimester) - You are a veteran - You have experienced a traumatic event (as defined by standard clinical criteria) - You have significant anxiety or depression symptoms - You have access to the internet and a smartphone, tablet, or computer - You may still be eligible even if you are currently in therapy or taking psychiatric medications **You may NOT be eligible if...** - You have a serious mental health condition that would prevent you from completing the program, such as active psychosis, uncontrolled bipolar disorder, or a severe substance use disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALCalm Moms-V

Calm Moms-V is the trauma-informed treatment developed and refined by the PI and being tested in the current study. Calm Moms-V is an online treatment program for trauma-exposed pregnant Veterans designed to target anxiety, stress, low mood, and trauma-related symptoms using empirically supported CBT techniques. Calm Moms-V includes four sessions and a booster session closer to delivery/postpartum. Sessions 1-4 are designed to be completed across four weeks (one session delivered each week). Each session is self-paced and designed to take approximately 45 minutes to complete.

BEHAVIORALCare As Usual

The control condition will be Care As Usual (CAU). CAU at SLVHCS involves participation in available services chosen by the patient with input from their providers. Further, for all pregnant Veterans that use VHA maternity benefits, CAU includes routine phone calls (throughout pregnancy and up to one-year postpartum) conducted by the site MCC to coordinate maternity benefits, facilitate additional services, and arrange for specific supplies (e.g., breast pump). Further, the SLVHCS MCC mails each pregnant Veteran enrolled in VHA a "welcome packet" that includes national, local, and VHA MH and physical health resources that may be useful to them during the perinatal period. Veterans in the CAU condition will be assessed at the same intervals as those in the active condition.


Locations(1)

Southeast Louisiana Veterans Health Care System, New Orleans, LA

New Orleans, Louisiana, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06906185


Related Trials