Calm Moms-V: a trauma-informed web program for pregnant Veterans
Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans (CDA 22-135)
This program tests whether Calm Moms-V, a web-based CBT program, can reduce anxiety, stress, and low mood in pregnant Veterans with a history of trauma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Sex | Female |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (New Orleans, Louisiana) |
| Trial ID | NCT06906185 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Pregnant Veterans in any trimester who endorse a DSM-5 Criterion A traumatic event, have elevated anxiety or depression symptoms, and can access the internet via smartphone, tablet, or computer are the ideal candidates.
Not a fit: Patients with active psychosis, uncontrolled bipolar disorder, a severe alcohol/substance use disorder, or acute suicidal ideation requiring immediate hospitalization, or those without internet/device access, may not benefit from this web program.
Why it matters
Potential benefit: If successful, Calm Moms-V could reduce anxiety, stress, and depressive symptoms during pregnancy and improve functioning and engagement with mental health care among pregnant Veterans.
How similar studies have performed: Other web-based and CBT interventions have reduced anxiety, stress, and mood symptoms, and the original Calm Moms program showed promise, but Calm Moms-V is a newer adaptation specifically for pregnant Veterans with limited prior testing.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Orleans, Louisiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.