Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

Pregnant women with posttraumatic stress disorder (PTSD) are at increased risk for adverse pregnancy outcomes, yet the majority of pregnant women with mental health needs do not receive treatment, with disparities in treatment utilization among low-income and racial and ethnic minority women. Perinatal mental health treatment gaps are foremost a consequence of behavioral health workforce shortages and a lack of data on PTSD treatment during pregnancy. Mental health stigma and medical mistrust due to racism further impact engagement in care. Written Exposure Therapy (WET) is a brief 5-session PTSD treatment that was designed to address the capacity-limiting concerns of first-line treatments (e.g., time burden of training and delivery). WET has demonstrated non-inferiority (and fewer dropouts) when compared to first-line PTSD treatments. As such, the empirical support and implementation advantages of WET suggest the promise of this intervention in addressing PTSD among pregnant women seen in usual care obstetrics settings. Training non-mental health specialists, such as community health workers (CHWs), to deliver WET may dually address workforce capacity challenges and patient engagement factors such as stigma. The objective of this research is to conduct a randomized controlled trial to examine both the effectiveness of WET for treatment of PTSD during pregnancy against an active control condition \[i.e., emotion focused supportive therapy (EFST)\] and the non-inferiority of WET delivery with a community health worker (CHW-WET) vs. WET delivery with a mental health clinician. A total of 240 pregnant women with PTSD receiving obstetrical care at Boston Medical Center (BMC), a large safety net hospital that cares for a racially and ethnically diverse population, will be recruited. Following a baseline visit, women will be randomized to either CHW-WET (N=80), standard WET (N=80), or EFST (N=80). Participants in either WET condition will receive 5 individual sessions focused on the use of writing to activate the trauma memory, process emotions, and make meaning. EFST participants will receive 5 individual sessions of supportive therapy. Participants will complete well-established measures of PTSD and other psychological symptoms (e.g., depression) and proposed moderators of treatment engagement at baseline, post-treatment, and 1-, 6-, and 12-months postpartum. Patients and providers will also complete measures and interviews following treatment to assess feasibility, acceptability, and appropriateness of the WET delivery approaches in a usual care setting. Aim 1 is to determine if a) CHW-WET is non-inferior to standard WET and b) CHW-WET has better retention than standard WET. Aim 2 is to demonstrate the effectiveness of WET for treatment of PTSD (vs. EFST) in an obstetrics setting. Exploratory Aim 3 will examine moderators of treatment engagement such as mental health stigma to inform a personalized approach to WET treatment delivery. Aim 4 is to conduct a process evaluation of the WET delivery approaches. This study will inform future efforts to improve access to and quality of care for treatment of PTSD during pregnancy.

• PTSD Checklist for DSM-5 (PCL-5) [Time frame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum]
• Patient Health Questionnaire (PHQ-9) [Time frame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum]
• Depression, Anxiety, and Stress Scale (DASS-21) - Anxiety Scale only [Time frame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum]
• Number of study sessions attended [Time frame: 1 month postpartum]
• Number of participants that completed all 5 study visits [Time frame: 1 month postpartum]
• Inventory of Psychosocial Functioning (IPF) [Time frame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum]
• Postpartum Bonding Questionnaire (PBQ) [Time frame: 1 month postpartum, 6 months postpartum, 12 months postpartum]
• Client Satisfaction Questionnaire (CSQ-8) [Time frame: 8 weeks]