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

Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans (CDA 22-135)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Calm Moms, an online program for pregnant Veterans who have been through trauma and have anxiety or depression symptoms. The program uses cognitive behavioral therapy (CBT), which teaches skills to manage thoughts, feelings, and actions, to help reduce anxiety, stress, and low mood.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Pregnant at any stage of pregnancy.
  • Have been through a traumatic event that meets the study’s rules, based on a trauma screening.
  • Have anxiety or depression symptoms with a score above 3 on either of the study’s short screening tests.
  • Have internet access and a smartphone, tablet, or computer to use the online program.
  • You may join even if you already get talk therapy or take mental health medicine.

Who can't join

  • Have a serious mental health condition that would keep you from completing the program. The study team will review your medical records before you join.
  • Examples include current psychosis (trouble knowing what is real), bipolar disorder that is not controlled, or a severe alcohol or drug use disorder.
  • Suicidal thoughts or actions that need hospital care or treatment right away.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

LA