Treatment Trials

9 Clinical Trials for Various Conditions

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RECRUITING
Empowering Perinatal Adolescents Through Writing
Description

This is a feasibility and acceptability study of Written Exposure Therapy (WET) for PTSD in pregnant and postpartum adolescents and youth with PTSD.

COMPLETED
Feasibility Trial of Narrative Exposure Therapy (NET) for Posttraumatic Stress Disorder (PTSD) During Pregnancy
Description

Posttraumatic stress disorder (PTSD) affects up to 35% of pregnant trauma survivors. Moreover, prenatal PTSD rates are up to 4 times higher among communities of color compared to white populations. PTSD during pregnancy has been linked to an increased risk of adverse perinatal and infant health outcomes and may even contribute to racial disparities in adverse perinatal outcomes. Although front-line treatments exist for PTSD, treatment research that specifically focus on pregnancy are extremely limited. Clinical studies examining the safety, acceptability, feasibility, and efficacy of treatments for PTSD during pregnancy are virtually non-existent. Thus, pregnant individuals with PTSD, particularly within low-income communities of color, are a vulnerable and underserved group in need of effective treatment approaches for their distress. Investigators propose to conduct a feasibility and acceptability study of a PTSD treatment, Narrative Exposure Therapy (NET), in a sample of pregnant individuals with PTSD in which low-income people of color are highly represented. Aim 1: The purpose of Aim 1 will be to examine feasibility. Investigators will evaluate the recruitment and assessment procedures. Aim 2: The purpose of Aim 2 will be to examine acceptability. Investigators will evaluate participant feedback of the NET intervention. Aim 3: The purpose of Aim 3 will be to examine the proportion of participants demonstrating clinically meaningful reduction in PTSD and perinatal depression symptoms from pre- to post-treatment. Investigators will aim to enroll up to 30 participants; participation will last up to ten months. Data sources will include questionnaires, electronic medical records, and qualitative feedback interviews. With this study, investigators aim to fill a critical gap in knowledge of how to safely and effectively treat PTSD among a vulnerable and underserved population (i.e., perinatal individuals of color).

RECRUITING
PTSD Screening in Pregnant Black Women
Description

This study will compare the effectiveness of two active screening interventions in improving post-traumatic stress disorder (PTSD) symptoms, maternal perinatal care utilization, satisfaction utilization of mental healthcare services, and maternal health and birth-related outcomes for Black pregnant women.

TERMINATED
Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
Description

The current study aims to test a brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. In this open trial pilot feasibility study, 20 pregnant women in their first trimester will be invited to participate in the study if they endorse elevated PTSD symptoms. Oxytocin and cortisol will be measured at baseline, one month post-intervention, three months post-intervention, and post-delivery to inform the relationship between these hormones, PTSD symptoms, and peripartum/postpartum outcomes. In addition to receiving the psychoeducation + skills intervention during their first trimester, women will be offered a "booster session" intervention following delivery to enhance utilization of skills during a critical period for maternal mental and physical health outcomes.

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

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.

COMPLETED
Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic
Description

The purpose of this study is to assess the health and wellbeing of pregnant and recently pregnant women during the COVID-19 pandemic using an online survey.

COMPLETED
Dialectical Behavior Therapy for Pregnant Women
Description

The cumulative effects of adverse childhood experiences (ACEs) can lead to prolonged activation of stress response systems, known as toxic stress. Toxic stress is increasingly recognized as an important contributor to socioeconomic and racial health disparities that emerge in early childhood and may persist across generations. African American women experience significant disparities in maternal and infant mortality, some of which may be attributable to toxic stress. The toxic stress response may increase risk factors for maternal and infant morbidity and mortality such as high-levels of stress hormones, high blood pressure, maternal PTSD and depression. Further, heightened maternal stress responses in pregnancy are associated with heightened infant stress responses, increasing the risk for the intergenerational transmission of toxic stress. Mindfulness-based interventions have demonstrated efficacy for a variety of mental health conditions, including depression and PTSD, are cost-effective, and scalable in diverse settings. Implementing mindfulness interventions for African American pregnant women with histories of ACEs and current depression and/or PTSD symptoms is novel and has the potential to interrupt the intergenerational cycle of toxic stress by improving maternal stress response and mental health. This study is a pilot, randomized controlled trial where participants will receive either Dialectical Behavior Therapy (DBT) Skills Training for 8 weeks (delivered virtually) or treatment as usual.

COMPLETED
Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse
Description

This study will evaluate the effectiveness of an interpersonally oriented treatment program called Reach Out for a Safe Environment in preventing depression and post-traumatic stress disorder in low-income pregnant women who have experienced recent partner abuse.

UNKNOWN
The Periviable Birth Plan
Description

Pregnant women who are at risk of delivering their infants in the periviable period can suffer a large amount of stress and anxiety. Moreover, many women feel a loss of control over their own pregnancy. There is some evidence that more counseling and planning can help reduce maternal stress and anxiety. Patients at risk of delivering in the periviable period will be randomized to either receive standard counselling or to complete the periviable birth plan.