Recruiting

Written Exposure Therapy

Sponsor:

VA Office of Research and Development

Code:

NCT05327504

Conditions

Substance Use Disorders

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Written Exposure Therapy

Neutral Topic Writing

Study Details

Brief summary:

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.

Conditions

Substance Use Disorders

Posttraumatic Stress Disorder

Study ID

NCT05327504

Start date

Sep 26, 2022

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

May 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Veterans ages 18 years old or older;
  • Meets DSM-5 criteria for at least one substance use disorder (SUD);
  • Meets DSM-5 criteria for PTSD;
  • Approved for SUD treatment at VA Connecticut Healthcare System.

Exclusion Criteria:

  • Veterans who meet current criteria for schizophrenia, schizophrenia-type disorders, or unmedicated mania or bipolar disorder as determined by QuickSCID-5;
  • current suicidal or homicidal risks necessitating a higher level of care;
  • Veterans who have received an Evidence-Based Psychotherapy for PTSD protocol within the past 6 months;
  • Problems that would prevent a participant from completing the writing intervention or study assessments (e.g., illiteracy). To assess for literacy, participants will read parts of the consent out loud.

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Written Exposure Therapy

Written Exposure Therapy is a 5 session treatment in which individuals write about their trauma event in a specified manner.

Neutral Topic Writing

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.

Primary outcome measure

  • PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 8-week Post-Baseline Follow-up ]
  • PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 12-week Post-Baseline Follow-up ]

Central Contacts and Locations

Central contacts

Locations

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Recruiting

West Haven, Connecticut, United States, 06516-2770

Contacts

Principal Investigator:

Sarah Meshberg-Cohen, PhD MS BS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • Addiction
  • Trauma and Stress Related Disorders
  • Substance Use Disorder
  • PTSD
  • Comorbidity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-02-19.