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

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.

Conditions

• Trauma-related Mental Health Symptoms

Interventions

BEHAVIORAL

Calm 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.

BEHAVIORAL

Care 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.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Mary E Shapiro, PhD MS · Southeast Louisiana Veterans Health Care System, New Orleans, LA

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-30

Primary Completion

2028-09-29

Completion

2030-03-29

Countries

• United States

Study Locations