Recruiting

Calm Moms

Sponsor:

VA Office of Research and Development

Code:

NCT06906185

Conditions

Trauma-related Mental Health Symptoms

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Calm Moms-V

Care As Usual

Study Details

Brief 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

Study ID

NCT06906185

Start date

Jun 30, 2025

Status verified date

May, 2026

Completion date

Mar 29, 2030

Anticipated

Primary completion date

Sep 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mary E Shapiro, PhD MS

(504) 507-2000mary.shapiro1@va.gov

Locations

Southeast Louisiana Veterans Health Care System, New Orleans, LA

Recruiting

New Orleans, Louisiana, United States, 70119

Contacts

Mary E Shapiro, PhD MS

(504) 507-2000mary.shapiro1@va.gov

Principal Investigator:

Mary E Shapiro, PhD MS

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • Anxiety
  • Depression
  • PTSD
  • Pregnant Veteran
  • Reproductive Mental Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-07.