Menu
Recruiting NCT05327504

Written Exposure Therapy for Veterans With SUD and PTSD

No phase Interventional Substance Use Disorders Posttraumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Written Exposure Therapy, Neutral Topic Writing.
Who it may be relevant to
Registry conditions: Substance Use Disorders, Posttraumatic Stress Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Written Exposure Therapy (WET) as a Brief Trauma Treatment for Veterans With Co-occurring Substance Use Disorders and PTSD

Overview

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.

Detailed description

This study is a randomized clinical trial within a Substance Use Disorder (SUD) specialty clinic to evaluate whether treatment as usual (TAU) plus Written Exposure Therapy (WET) is superior to TAU augmented by a neutral topic writing condition on both PTSD and addiction outcomes for Veterans in SUD treatment. Veterans with a current diagnosis of SUD and comorbid PTSD will be randomized to either WET plus TAU or TAU augmented by a neutral topic writing condition. During the first writing session, participants will be asked to write about either a personal traumatic experience (WET) or a neutral topic (control). In sessions 2 through 5, participants will again meet with the study therapist for 45 minutes (maintaining the same writing condition as assigned in session one). Measures of trauma symptoms, distress, and mood will be collected at each writing session, with additional assessments at baseline, at post-treatment (following 5 writing sessions), 8-weeks, and 12-weeks post-baseline assessment. The primary aim of this study is to examine whether WET augmentation of TAU improves trauma symptoms for Veterans with SUD and PTSD who are receiving outpatient SUD treatment compared to TAU with a neutral writing control. The secondary aim will examine whether WET improves SUD outcomes for Veterans with comorbid PTSD compared to TAU with a neutral writing control. If results prove promising, they will support WET as an effective brief, cost efficient, easy to disseminate, adjunct to current SUD treatment for Veterans with comorbid PTSD.

Interventions

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

  • 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]
Secondary outcome measures (1)
  • Timeline Follow-Back (TLFB) [Time frame: 8-week Post-Baseline Follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven

Publications

  • Meshberg-Cohen S, Cook JM, Bin-Mahfouz A, Petrakis IL. Written exposure therapy for veterans with co-occurring substance use disorders and PTSD: Study design of a randomized clinical trial. Contemp Clin Trials. 2024 Apr;139:107475. doi: 10.1016/j.cct.2024.107475. Epub 2024 Feb 15. PMID 38365173

Identifiers

NCT: NCT05327504 · MHBP-010-21F

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗