Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans
Recruiting · NCT06906185 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
- f 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 is running
1 location listed across 1 US state.
- Southeast Louisiana Veterans Health Care System, New Orleans, LA - New Orleans, Louisiana, United States