Written Exposure Therapy for Veterans With SUD and PTSD (WET)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use Disorders; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Written Exposure Therapy; Behavioral: Neutral Topic Writing

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.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Merritt; Phone Number: 6476 (352) 548-6000; Email: michael.merritt@va.gov
• Study Contact Backup: Name: Jenelle Newcomb, BA; Phone Number: 2874 (203) 932-5711; Email: Jenelle.Newcomb@yale.edu

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516-2770
      • Recruiting
      • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
      • Contact: Diana DeNegre; Phone Number: 5217 203-932-5711; Email: diana.denegre@yale.edu
      • Principal Investigator: Sarah Meshberg-Cohen, PhD MS BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Written Exposure Therapy; Written Exposure Therapy is a 5 session treatment in which individuals write about their trauma event in a specified manner.; Other Names: Trauma-focused Treatment
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.	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.; Other Names: Control Writing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist for DSM-5 (PCL-5)	PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL scores will be collected based upon symptoms experienced in the past month at Baseline as well as each Post-Baseline Follow-up (8-weeks and 12-weeks), while the weekly PCL-5 will be administered at each of the five writing sessions and post-treatment (after 5 writing sessions) assessment. PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity.	8-week Post-Baseline Follow-up
PTSD Checklist for DSM-5 (PCL-5)	PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL scores will be collected based upon symptoms experienced in the past month at Baseline as well as each Post-Baseline Follow-up (8-weeks and 12-weeks), while the weekly PCL-5 will be administered at each of the five writing sessions and post-treatment (after 5 writing sessions) assessment. PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity.	12-week Post-Baseline Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeline Follow-Back (TLFB)	Timeline Follow-Back (TLFB) will be provided at baseline, and at post-treatment (after 5 writing sessions), 8-week, and 12-week post-baseline follow-up. Calendar-based interviews using the Timeline Follow-Back (TLFB) method will document the frequency of drug and alcohol use for the 3 months prior to baseline assessment, and during the writing sessions (taken at post-treatment follow-up), 8-week, and 12-week post-baseline follow-up. Following baseline, the TLFB will capture days since last assessment (e.g., days between baseline and post-treatment, post-treatment, and 8-weeks, and 8- to 12-week follow-up). Higher numbers of days of use will equal higher substance use.	8-week Post-Baseline Follow-up

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Sarah Meshberg-Cohen, PhD MS BS, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Estimated): May 12, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: PTSD; Addiction; Comorbidity; Substance Use Disorder; Trauma and Stress Related Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Substance-Related Disorders; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: MHBP-010-21F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified, anonymized dataset will be created. This dataset may be shared with other investigators, upon written request, under a data use agreement prohibiting the recipient from identifying or re-de-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The data sharing agreement will also restrict redistribution to third parties and proper acknowledgment of the data source. These datasets will be shared per guidelines provided by VACHS Information Security Officer.
• IPD Sharing Time Frame: After study completion
• IPD Sharing Access Criteria: After study completion for no less than 7 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No