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

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
VA Office of Research and Development
Study ID
NCT06906185
Status
Recruiting
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Conditions

  • Trauma-related Mental Health Symptoms

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Calm Moms-V — BEHAVIORAL
    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.
  • Care As Usual — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
May 2026
Primary completion
Sep 29, 2028
Completion
Mar 29, 2030

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Active
    The active condition will be the Calm Moms-V treatment.
  • Active Comparator: Control
    The control condition will be care as usual in VHA.

Primary Outcome Measure

Acceptability of Intervention Measure (AIM) [ Time Frame: Aim 2 at one-month follow-up and at three-month follow-up. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Southeast Louisiana Veterans Health Care System, New Orleans, LANew OrleansLouisiana70119
Mary E Shapiro, PhD MS
[email protected]
(504) 507-2000
Mary E Shapiro, PhD MS (PRINCIPAL_INVESTIGATOR)

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By research site
Southeast Louisiana Veterans Health Care System, New Orleans, LA· New Orleans, LA

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