Written Exposure Therapy for Veterans With SUD and PTSD

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
VA Office of Research and Development
Study ID
NCT05327504
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Written Exposure Therapy — BEHAVIORAL
    Written Exposure Therapy is a 5 session treatment in which individuals write about their trauma event in a specified manner.
  • Neutral Topic Writing — BEHAVIORAL
    Treatment as Usual augmented by 5 sessions of Neutral Topic Writing which involves writing about specific objects (e.g., what they have eaten over the past week) or events (e.g., what they did since yesterday) in detail without discussing thoughts or feelings.

Study Details

The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). While SUD treatment programs traditionally do not address PTSD, effective trauma treatments have been used successfully among those with substance use comorbidities. WET is a brief trauma-focused intervention shown to effectively treat PTSD. In a recent acceptability and feasibility pilot study among Veterans with co-occurring SUD and PTSD, results showed a decrease in PTSD symptoms among participants receiving WET. The goal of the present study is to improve outcomes for Veterans who present for SUD treatment with comorbid SUD/PTSD.

Key Dates

Start date
Sep 26, 2022
Status verified
Feb 2026
Primary completion
May 12, 2027
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: Written Exposure Therapy
    Written Exposure Therapy (WET) plus Treatment As Usual (TAU). WET is a 5 session, evidence-based trauma-focused written narrative exposure treatment. At each session, patients are instructed to write about the same trauma event and therapists provide feedback about adherence and offer suggestions. The first session includes psychoeducation about PTSD and a treatment rationale prior to general trauma narrative writing instructions, and specific instructions for completing the first writing session, before completing the first writing (30 minutes) session. Participants are instructed to write about the same trauma event at each following session, with an emphasis on delving into their deepest emotions and thoughts, in as much detail as possible, about the event. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant.
  • Active Comparator: Neutral Topic Writing
    Treatment As Usual (TAU) augmented by a neutral topic writing condition. The neutral topic writing condition involves writing about an assigned topic during each of the five writing sessions. As opposed to writing about trauma, the specific focus of this condition is on writing for 30 minutes about topics related to their life without writing about emotions or opinions. Rather, they are asked to write about specific objects or events in detail, as accurately as possible, and with as much description as possible. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant.

Primary Outcome Measure

PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 8-week Post-Baseline Follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest HavenConnecticut06516-2770
Amanda O'Brien, MA
203-932-5711
Diana DeNegre
(203) 932-5711
Sarah Meshberg-Cohen, PhD MS BS (PRINCIPAL_INVESTIGATOR)

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