Calm Moms-V for PTSD in Pregnant Veterans

Overseen By Mary E Shapiro, PhD MS

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Active psychosis, Uncontrolled bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based program called Calm Moms-V, designed to assist pregnant Veterans who have experienced trauma. The program aims to reduce anxiety, stress, and low mood using proven therapy techniques tailored for pregnancy. Participants will either use the Calm Moms-V program or receive standard care. Pregnant Veterans experiencing anxiety or depression and who have internet access might be a good fit for this trial. As an unphased study, this trial offers a unique opportunity for participants to access innovative support tailored specifically to their needs.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. You can still participate if you are using psychotropic medications.

What prior data suggests that the Calm Moms-V program is safe for pregnant Veterans?

Research shows that Calm Moms-V, an online program, uses cognitive behavioral therapy (CBT). CBT is known to safely and effectively reduce anxiety, stress, and low mood. Although specific safety data for Calm Moms-V is not available, its foundation in CBT suggests it is likely safe. Previous studies have found that pregnant Veterans using similar programs experience reduced stress and anxiety. Calm Moms-V is designed to address these specific needs, enhancing its effectiveness for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for PTSD in pregnant veterans, which often involve medications and traditional therapy, Calm Moms-V is a specialized approach that focuses on the unique needs of pregnant veterans. This treatment is different because it integrates trauma-informed care specifically tailored for women during pregnancy, aiming to address both mental health and maternal well-being simultaneously. Researchers are excited about Calm Moms-V because it offers a holistic approach that could provide more effective and comprehensive support compared to typical PTSD treatments, potentially improving outcomes for both mothers and their babies.

What evidence suggests that the Calm Moms-V program is effective for reducing anxiety, stress, and low mood symptoms in pregnant Veterans?

Research has shown that online programs using cognitive behavioral therapy (CBT) methods, such as Calm Moms-V, effectively reduce anxiety, stress, and low mood. Previous studies found that similar programs significantly lowered PTSD symptoms and helped participants manage their emotions better. In this trial, participants will receive either the Calm Moms-V treatment or care as usual in VHA. Controlling these symptoms is crucial for pregnant women, as PTSD during pregnancy can lead to issues like early delivery. Calm Moms-V is specifically designed to help pregnant Veterans with these mental health challenges, potentially improving their overall well-being during pregnancy. ^{1 3 4 6 7}

Who Is on the Research Team?

Mary E Shapiro, PhD MS

Principal Investigator

Southeast Louisiana Veterans Health Care System, New Orleans, LA

Are You a Good Fit for This Trial?

This trial is for pregnant veterans who have experienced trauma and are dealing with anxiety, stress, or low mood. It's designed to help them cope during pregnancy and improve their mental health. Participants should be willing to engage with a web-based cognitive behavioral therapy program.

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)

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Calm Moms-V web-based treatment program, which includes four weekly sessions and a booster session close to delivery/postpartum

5 weeks

Follow-up

Participants are monitored for acceptability and feasibility of the intervention, as well as changes in anxiety, depression, and functional impairment

3 months

Assessments at one-month, two-month, and three-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Calm Moms-V

Trial Overview The study tests 'Calm Moms-V,' a web-based treatment based on cognitive behavioral therapy techniques tailored for pregnant women with trauma history. It compares the effectiveness of this intervention against standard care in reducing anxiety, stress, and improving overall functioning.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

The active condition will be the Calm Moms-V treatment.

Group II: Control Active Control 1 Intervention

The control condition will be care as usual in VHA.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The NAP Study is a large-scale clinical trial involving 1224 veterans with PTSD, comparing the efficacy of three insomnia medications (trazodone, eszopiclone, and gabapentin) against a placebo over 12 weeks, aiming to find effective treatments for PTSD-related insomnia.

The study features an adaptive design that allows for real-time adjustments based on interim results, potentially enhancing the statistical power of the remaining treatment comparisons and guiding future research on biomarkers for treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of the National Adaptive Trial for PTSD-related Insomnia (NAP Study), VA Cooperative Study Program (CSP) #2016. Krystal, JH., Chow, B., Vessicchio, J., et al.[2022]

The Survivor Moms' Companion (SMC) intervention significantly reduced PTSD symptoms and improved affect regulation and interpersonal sensitivity among 56 women in a high-risk perinatal population, indicating its efficacy in addressing mental health during pregnancy.

Participants who completed the core modules showed clinically meaningful improvements, with many moving from clinical to nonclinical ranges for PTSD and depression, demonstrating the potential of community health workers to effectively deliver trauma-specific support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Survivor Moms' Companion Trauma-Specific Perinatal Psychoeducation Intervention in a Community Outreach Program: An Open Pilot. Sperlich, M., Kabilamany, P.[2022]

A brief psychotherapeutic intervention consisting of four sessions significantly reduced PTSD symptoms and depression in 32 pregnant women, with improvements sustained at post-treatment and postpartum follow-ups.

The study highlights the need for targeted mental health interventions for low-income, minoritized pregnant women, who are at higher risk for trauma-related symptoms and may lack access to traditional mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in and Benefits of a Short-Term, Brief Psychotherapy Intervention for PTSD During Pregnancy. Kornfield, SL., Johnson, RL., Hantsoo, LV., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/mR8A9QNp0E-HWEwkLH-7Mw/project-details/11107237

Project Details 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06906185

Adaptation and Examination of a Trauma-informed ... 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 ...

3. withpower.com withpower.com/trial/phase-wounds-and-injuries-6-2025-7b3ee

Calm Moms-V for PTSD in Pregnant Veterans The Survivor Moms' Companion (SMC) intervention significantly reduced PTSD symptoms and improved affect regulation and interpersonal sensitivity among 56 women ...

4. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561326X24005997

Web-Based Intervention (SunnysideFlex) to Promote ... PTSD during the gestational period is associated with an increased risk for poor pregnancy and birthing outcomes, including miscarriage, ectopic pregnancy, ...

5. hsrd.research.va.gov hsrd.research.va.gov/research/citations/pubbriefs/articles.cfm?RecordID=686

Women Veterans with PTSD at Significantly Increased Risk of ... Mothers with active PTSD were at 35% increased odds of having a spontaneous pre-term delivery (two excess pre-term births per 100 deliveries), even after ...

6. trialx.com trialx.com/clinical-trials/listings/300214/adaptation-and-examination-of-a-trauma-informed-intervention-for-pregnant-veterans/

Adaptation and Examination of a Trauma-informed ... Pregnant Veterans who engage in Calm Moms-V may (1) experience a reduction in anxiety, stress, and low mood during pregnancy, (2) have improved ...

7. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05572-y

Challenges of living with veterans with post-traumatic stress ... This qualitative study used conventional content analysis to explore Challenges of spouses of veterans with post-traumatic stress disorder.