Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University
Study ID
NCT05486793
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Written Exposure Therapy (WET)
    Participants randomized into this arm will receive the WET intervention administered by mental health clinicians.
  • Experimental: Community Health Workers- Written Exposure Therapy (CHW-WET)
    Participants randomized into this arm will receive the WET intervention administered by community health workers.
  • Active Comparator: Emotion Focused Supportive Therapy (EFST)
    Participants randomized into this arm will receive the EFST intervention.

Primary Outcome Measure

Clinician Administered Scale for PTSD-5 (CAPS-5) at baseline [ Time Frame: baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical Center and remoteBostonMassachusetts02118
Hannah Brown, MS
[email protected]
617-358-3324

Find similar trials in Boston, MA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Boston Medical Center and remote· Boston, MA

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