Clinical trial NCT05486793: Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study
Official title: A Non-Inferiority Trial Testing Delivery of Written Exposure Therapy by Community Health Workers For Treatment of PTSD During Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: Written Exposure Therapy (WET)
Emotion Focused Supportive Therapy (EFST)
Community Health Worker (CHW)
Antepartum care
perinatal mental health
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-08-04
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in a 1:1:1 ratio using a permuted block strategy (random block sizes of 2 and 4) and stratified by PTSD severity (met full PTSD criteria/not) and major depressive diagnosis (MDD).
Primary purpose: TREATMENT

Brief summary: The majority of women with perinatal posttraumatic stress disorder (PTSD) do not receive mental health treatment despite the documented associations between PTSD and adverse pregnancy outcomes; this is likely due to workforce shortages, lack of data on the effectiveness of existing evidence-based treatment for PTSD in usual care obstetrics settings, and patient-level barriers to engagement such as stigma. The proposed study is a randomized controlled trial, which will examine the effectiveness of a brief evidence-based treatment for PTSD (i.e., Written Exposure Therapy) during pregnancy and the non-inferiority of delivery of this treatment by community health workers vs. delivery by mental health clinicians.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant woman receiving prenatal care at BMC Obstetrics and Gynecology (OB/GYN) Department
* Presenting for prenatal care prior to gestational age of 28 weeks
* Meet diagnostic or subthreshold criteria (i.e., endorsement of 3 out of the 4 symptom clusters) for PTSD on the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

Exclusion Criteria:

* Clinician judgment that the patient is not appropriate for outpatient level care (i.e., patient needs detox, inpatient, or residential treatment)
* Current psychosis or unstable bipolar disorder diagnosis (determined via clinician-administered interview)
* Currently receiving exposure-based PTSD treatment (e.g., WET, prolonged exposure, cognitive processing therapy) elsewhere
* Current incarceration. Incarcerated individuals are only seen at BMC for obstetrical care and are not allowed to receive mental health care outside of their correctional facility

Primary outcomes:
measure: Clinician Administered Scale for PTSD-5 (CAPS-5) at baseline
timeFrame: baseline
measure: Clinician Administered Scale for PTSD-5 (CAPS-5) at 8 weeks
timeFrame: 8 weeks
measure: Clinician Administered Scale for PTSD-5 (CAPS-5) at 1 month postpartum
timeFrame: 1 month postpartum
measure: Clinician Administered Scale for PTSD-5 (CAPS-5) at 6 months postpartum
timeFrame: 6 months postpartum
measure: Clinician Administered Scale for PTSD-5 (CAPS-5) at 12 months postpartum
timeFrame: 12 months postpartum
Secondary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
measure: Depression, Anxiety, and Stress Scale (DASS-21) - Anxiety Scale only
timeFrame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
measure: Number of study sessions attended
timeFrame: 1 month postpartum
measure: Number of participants that completed all 5 study visits
timeFrame: 1 month postpartum
measure: Inventory of Psychosocial Functioning (IPF)
timeFrame: baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum
measure: Postpartum Bonding Questionnaire (PBQ)
timeFrame: 1 month postpartum, 6 months postpartum, 12 months postpartum
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center and remote
state: Massachusetts
Study officials:
affiliation: BUSM Department of Psychiatry and VA Boston Healthcare System
name: Yael I Nillni, PhD
role: PRINCIPAL_INVESTIGATOR
References: