About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Written Exposure Therapy (WET)
Behavioral
5 individual sessions that cover psychoeducation about PTSD, the rationale for exposure treatment, and directing patients to write in session for 30 minutes about their traumatic experience using scripted instructions. Each session includes unique writing instructions. Earlier sessions focus on describing the details of a traumatic stressor linked to their symptoms, with particular attention to felt emotions and thoughts. Later writing sessions focus on writing about the meaning of the traumatic event and how the event has changed their life and how they relate to other people. After writing, therapists spend \~10 minutes processing the patient's experience with the writing. WET does not include between session assignments.
Emotion Focused Supportive Therapy (EFST)
Behavioral
5 individual sessions where patients choose what problems to discuss in each session. Therapists validate and clarify patients' emotions and engage in problem solving during sessions.

Treatment groups

240 Participants

are divided into 3 treatment groups

Group A: Written Exposure Therapy (WET)Experimental treatment 1 intervention

Group B: Community Health Workers- Written Exposure Therapy (CHW-WET)Experimental treatment 1 intervention

Group C: Emotion Focused Supportive Therapy (EFST)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinician Administered Scale for PTSD-5 (CAPS-5) at baseline

PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5 CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.

Time frame

baseline

2

Clinician Administered Scale for PTSD-5 (CAPS-5) at 8 weeks

PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.

Time frame

8 weeks

3

Clinician Administered Scale for PTSD-5 (CAPS-5) at 1 month postpartum

PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.

Time frame

1 month postpartum

4

Clinician Administered Scale for PTSD-5 (CAPS-5) at 6 months postpartum

PTSD symptom severity will be assessed with the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), a structured diagnostic interview that obtains information about symptom frequency/intensity for all 20 PTSD symptoms using a 5-point scale to obtain a total PTSD severity score. The scale also assesses social and occupational functioning and dissociation symptoms. Scores range from 0-80, with higher scores indicating greater severity.

Time frame

6 months postpartum

Secondary outcomes

1

PTSD Checklist for DSM-5 (PCL-5)

Self-reported PTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5). Scores range from 0-80, with higher scores indicating greater severity.

Time frame

baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum

2

Patient Health Questionnaire (PHQ-9)

Self-reported depressive symptoms will be assessed using the Patient Health Questionnaire (PHQ-9). Scores range from 0-27 with higher scores indicating greater depressive symptom severity.

Time frame

baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum

3

Depression, Anxiety, and Stress Scale (DASS-21) - Anxiety Scale only

Self-reported anxiety symptoms will be assessed using the anxiety scale of the Depression, Anxiety, and Stress scale (DASS-21). Items are summed and then multiplied by 2. Scores range from 0 - 42, with higher scores indicating greater severity.

Time frame

baseline, 8 weeks, 1 month postpartum, 6 months postpartum, 12 months postpartum

4

Number of study sessions attended

The number of sessions the participant attended will be documents from 0 to 5.

Time frame

1 month postpartum

Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts