Clinical trial NCT06906185: Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans
Official title: Adaptation and Examination of a Trauma-informed Intervention for Pregnant Veterans (CDA 22-135)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma-related Mental Health Symptoms
Keywords: Anxiety
Depression
PTSD
Pregnant Veteran
Reproductive Mental Health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-04-02
Enrollment: 36
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: During Aim 2, Veterans are randomly assigned (1:1 using a random number generated table) to the active (Calm Moms-V) or control (care as usual in VHA) condition.

Aim 1 and Aim 3 do not involve a clinical trial or randomization.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Background: Trauma exposure and subsequent mental health symptoms are exceptionally common among pregnant Veterans and associated with a variety of negative perinatal outcomes (e.g., postpartum depression, gestational diabetes, low birth weight). The mechanism linking trauma exposure and poor perinatal outcomes is elevated anxiety, stress, and low mood during pregnancy. Thus, treatments designed to target these symptoms among trauma-exposed pregnant Veterans are critical. The Veterans Health Administration (VHA) has started to address this need, but the available treatments are not sufficient because they do not address two common symptoms of trauma exposure (i.e., anxiety and stress) or mental health symptoms during pregnancy. Further, pregnant Veterans with a trauma history report myriad barriers to engaging in mental health treatment (e.g., stigma, accessibility, and availability). Calm Moms-V is a treatment program that directly addresses the gaps in care and barriers to treatment for this vulnerable population. Calm Moms-V is an online treatment program rooted in empirically supported cognitive behavioral therapy (CBT) techniques shown to be effective in reducing anxiety and stress and improving mood. Calm Moms-V was adapted from the original Calm Moms program (based on Veteran stakeholder feedback) and now includes four weekly sessions and a booster session close to delivery/postpartum. The current study will build on this work by examining the resulting Calm Moms-V among pregnant Veterans.

Significance: Although a small proportion of the Veteran population, pregnant Veterans are especially vulnerable because they (1) have often recently transitioned from Active Duty, (2) carry a heavy burden of trauma and mental health symptoms, (3) often have partners still on Active Duty, and (4) face fragmented care because obstetrics services must be provided by community providers. Calm Moms-V is an accessible, low-cost, and evidence-based treatment program. Pregnant Veterans who engage in Calm Moms-V may (1) experience a reduction in anxiety, stress, and low mood during pregnancy, (2) have improved functioning and reduced impairment during pregnancy, and (3) show interest and engagement with VHA mental health care.

Innovation/Impact: Trauma-exposed pregnant Veterans have low mental health engagement and report a disinterest in traditional trauma-focused treatment; however, they have among the worst perinatal outcomes, in part due to elevated mental health symptoms. Calm Moms-V will directly address these gaps by providing a program that may reduce anxiety, stress, and low mood symptoms and enhance engagement in mental health treatment.

Specific Aims: The current study aims to: (1) Collect feedback on Veteran experience with Calm Moms-V and make final refinements, (2) Conduct a pilot acceptability and feasibility trial of Calm Moms-V at SLVHCS, and (3) Examine barriers and facilitators to implementation of Calm Moms-V at additional sites.

Methodology: The current study will utilize a mixed-methods approach targeting pregnant Veterans and key VHA stakeholders.

Next Steps/Implementation: This research has the long-term potential to make trauma-informed mental health care readily available for all pregnant Veterans. Although the implementation and dissemination implications of Calm Moms-V are nascent, Calm Moms-V may be useful in a stepped-care framework or as a way to connect pregnant Veterans with additional mental health care. Data from this study will be used to inform additional research aimed at examining the broad implementation of Calm Moms-V in VHA. Further, in collaboration with partners, the investigators will work to disseminate results from this study and treatment materials through various local and national outlets.

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.

Primary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Aim 2 at one-month follow-up and at three-month follow-up.
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Aim 2 at one-month follow-up and at three-month follow-up.
Secondary outcomes:
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Aim 2 at all assessment timepoints (baseline, one-month follow-up, two-month follow-up, and three-month follow-up).
Other outcomes:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Aim 2 at all assessment timepoints (baseline, one-month follow-up, two-month follow-up, and three-month follow-up).
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Aim 2 at all assessment timepoints (baseline, one-month follow-up, two-month follow-up, and three-month follow-up).
Locations:
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System, New Orleans, LA
state: Louisiana
Study officials:
affiliation: Southeast Louisiana Veterans Health Care System, New Orleans, LA
name: Mary E Shapiro, PhD MS
role: PRINCIPAL_INVESTIGATOR
References: