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Calm Moms-V for Pregnant Veterans with Trauma-Related Symptoms

This study is testing an online program called Calm Moms-V for pregnant Veterans who have experienced trauma and are dealing with anxiety, stress, or low mood. Calm Moms-V uses techniques from cognitive behavioral therapy (CBT) to help reduce these symptoms. Researchers want to see if Calm Moms-V is acceptable and practical for participants, compared to receiving usual care (Care As Usual) from the VA. You might be able to join if you are a pregnant woman, have experienced a traumatic event, and have symptoms of anxiety or depression. The study plans to enroll 36 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing Calm Moms-V to usual care, with a planned enrollment of 36 participants. The study aims to understand if Calm Moms-V is acceptable and feasible.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up at one month and three months after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06906185

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

Recruiting
NAAll AgesInterventionalHealth services
VA Office of Research and Development
~36 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:Calm Moms-VCare As Usual

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability of Intervention Measure (AIM)
Measured over Aim 2 at one-month follow-up and at three-month follow-up.
+1 more outcome measured

Conditions

Trauma-related Mental Health Symptoms

Explore related trials

AnxietyDepressionPost-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
Louisiana1

Study leadership

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

Who to contact

Mary E Shapiro, PhD MS
[email protected]
(504) 507-2000 · ext. 67282
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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)

What this trial measures

  • Acceptability of Intervention Measure (AIM)Aim 2 at one-month follow-up and at three-month follow-up.

    The Acceptability of Intervention Measure (AIM) is a brief self-report measures designed to assess the extent to which an intervention is acceptable. Scores range from 8 to 40 with higher scores indicating greater acceptability (better outcome = high acceptability). The AIM is psychometrically sound and have been validated in previous research. The AIM will be administered to Veterans randomized to Calm Moms-V during the one-month and three-month follow-up assessments.

  • Feasibility of Intervention Measure (FIM)Aim 2 at one-month follow-up and at three-month follow-up.

    The Feasibility of Intervention Measure (FIM) is a brief self-report measures designed to assess the extent to which an intervention is feasible. Scores range from 8 to 40 with higher scores indicating greater feasibility (better outcome = high feasibility). The FIM is psychometrically sound and has been validated in previous research. The FIM will be administered to Veterans randomized to Calm Moms-V during the one-month and three-month follow-up assessments.