Calm Moms-V: a trauma-informed web program for pregnant Veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Calm Moms-V is a tailored online cognitive behavioral therapy program for pregnant Veterans with prior trauma exposure, delivered as four weekly sessions plus a booster near delivery. The intervention targets anxiety, stress, and low mood using evidence-based CBT techniques adapted for pregnancy and Veteran-specific concerns. Participants who meet symptom and trauma criteria and have internet access will be enrolled and compared with care as usual, with measures of symptoms, functioning, and engagement collected over the perinatal period. The study will also collect information about implementing Calm Moms-V at additional VA sites to inform wider rollout.

Why it matters

Who can join: the full rules

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.

Where it's running

• Southeast Louisiana Veterans Health Care System, New Orleans, LA
  New Orleans, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Mary E Shapiro, PhD MS — Southeast Louisiana Veterans Health Care System, New Orleans, LA
• Study coordinator: Mary E Shapiro, PhD MS
• Email: mary.shapiro1@va.gov
• Phone: (504) 507-2000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.