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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Calm Moms-V for PTSD in pregnant veterans?

Research on similar treatments, like the Seeking Safety intervention, shows that psychosocial education can significantly reduce PTSD symptoms in pregnant women. Additionally, a brief psychotherapy intervention has been effective in decreasing PTSD and depression symptoms during pregnancy, suggesting that similar approaches may benefit pregnant veterans with PTSD. ^{1 2 3 4 5}

Is the Calm Moms-V treatment safe for pregnant veterans with PTSD?

The research does not provide specific safety data for Calm Moms-V, but it highlights that pregnant veterans with PTSD are often prescribed medications like SSRIs and SNRIs, which are generally considered safe but should be reviewed with healthcare providers during pregnancy. ^{2 3 6 7 8}

How is the Calm Moms-V treatment different from other PTSD treatments for pregnant veterans?

Calm Moms-V is unique because it focuses on behavioral treatments, which are preferred by women veterans over medication, and it may address both PTSD and related sleep disturbances without relying on drugs. ^{9 10 11 12 13}

Research Team

Mary E Shapiro, PhD MS

Principal Investigator

Southeast Louisiana Veterans Health Care System, New Orleans, LA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Postpartum outcomes of a pilot prenatal care-based psychosocial intervention for PTSD during pregnancy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Posttraumatic Stress Disorder in a Cohort of Pregnant Active Duty U.S. Military Servicewomen. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Medications with Potential for Fetal Risk Prescribed to Veterans. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Engagement in and Benefits of a Short-Term, Brief Psychotherapy Intervention for PTSD During Pregnancy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Using Prenatal Advocates to Implement a Psychosocial Education Intervention for Posttraumatic Stress Disorder during Pregnancy: Feasibility, Care Engagement, and Predelivery Behavioral Outcomes. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The effects of PTSD treatment during pregnancy: systematic review and case study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Comparative safety of benzodiazepines and opioids among veterans affairs patients with posttraumatic stress disorder. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Sleep Disturbances in OEF/OIF/OND Veterans: Associations with PTSD, Personality, and Coping. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Eszopiclone for the treatment of posttraumatic stress disorder and associated insomnia: a randomized, double-blind, placebo-controlled trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Design of the National Adaptive Trial for PTSD-related Insomnia (NAP Study), VA Cooperative Study Program (CSP) #2016. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Insomnia and symptoms of post-traumatic stress disorder among women veterans. [2015]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Insomnia characteristics and clinical correlates in Operation Enduring Freedom/Operation Iraqi Freedom veterans with post-traumatic stress disorder and mild traumatic brain injury: an exploratory study. [2022]