Written Exposure in Substance Treatment (WEST)

Project WEST (Written Exposure in Substance Treatment) Part 2

The purpose of this pilot randomized clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) within the context of residential substance use disorder (SUD) treatment. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. The main questions the study aims to answer are: 1) Is the delivery of WET feasible in short term residential SUD treatment for individuals with severe SUD; 2) Do participants in the TAU+WET condition have greater reductions in PTSD symptoms pre/post treatment compared to participants in TAU alone?

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Treatment as Usual; Behavioral: Written Exposure Therapy

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Maryland Treatment Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 18 years old
• Fluent in English
• Cognitively able to provide consent to the research
• Enrolled in inpatient treatment at the clinical site where the research takes place
• Meet criteria for probable PTSD based on PCL-5 score
• Be early enough in their residential stay to allow time to complete the WET protocol
• Have a clear memory of the traumatic event so they are able to write about itin detail

Exclusion Criteria:

• Reports significant suicidal or homicidal ideation with intent, untreated psychosis, or have other health limitations that may interfere with their ability to participate in the research

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as Usual (TAU); Participants randomized to the TAU condition, which involves the standard clinical services available in a short term residential SUD treatment context. Examples of these services are: Individual counseling/case management; Group psychoeducation; Group counseling; Assessment and addiction related medical treatment from a physician; Pharmacotherapy for substance use disorders; 12-step groups. However, participants in this group do not receive treatment that is targeted at decreasing PTSD symptoms.	Behavioral: Treatment as Usual; Treatment as Usual will include a variety of standard care services offered in short term residential treatment. For example, participants receiving TAU will participate in individual case management/general counseling sessions focused on their substance use disorder and its consequences, group based psychoeducation sessions, group based counseling sessions (e.g., relapse prevention planning), individual services with a medical provider and pharmacotherapy (e.g., for withdrawal, relapse prevention, or co-occurring conditions)
Experimental: TAU + Written Exposure Therapy (WET); Participants in this condition receive everything included in TAU plus 5 individual sessions of WET delivered by a therapist. Sessions average less than 60 minutes and primarily involve writing about the traumatic experience that is guided by the therapist.	Behavioral: Treatment as Usual; Treatment as Usual will include a variety of standard care services offered in short term residential treatment. For example, participants receiving TAU will participate in individual case management/general counseling sessions focused on their substance use disorder and its consequences, group based psychoeducation sessions, group based counseling sessions (e.g., relapse prevention planning), individual services with a medical provider and pharmacotherapy (e.g., for withdrawal, relapse prevention, or co-occurring conditions); Behavioral: Written Exposure Therapy; Written Exposure Therapy is a brief, evidenced based intervention for PTSD. WET is generally delivered individually across 5 sessions in which the therapist guides the patient through writing exercises. Across exposure sessions, participants experience habituation so that their symptoms decrease by the end of treatment. WET has an established evidence base in general outpatient psychotherapy for PTSD, but has not been adapted or tested in residential SUD treatment settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of WET	PTSD symptom reduction pre/post intervention by treatment arm as measured by the posttraumatic checklist for DSM-5 (PCL-5). The PCL-5 is a self-report questionnaire yielding scores ranging from 0-80 with higher scores indicating greater symptomology.	Pre/post intervention window (approximately 3 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of WET delivered in residential SUD treatment context	Percentage of participants in the WET arm who were able to complete the treatment (5 sessions) prior to discharge	Up to 4 weeks, or until the participant discharges from residential treatment (whichever comes first).
Acceptability of WET delivered in residential SUD treatment context	Treatment satisfaction scores among WET participants as measured by the 2-part credibility/expectancies questionnaire (CEQ). The CEQ utilizes two scoring systems that range from 1-9 or 0%-100%. with higher scores indicating greater acceptability.	Collected post intervention window (approximately 3 weeks from randomization)

Collaborators and Investigators

• Sponsor: Potomac Health Foundations
• Collaborators: University of Maryland, Baltimore County

Publications and helpful links

General Publications

• Schacht RL, Wenzel KR, Meyer LE, Mette M, Mallik-Kane K, Rabalais A, Berg SK, Fishman M. A pilot test of Written Exposure Therapy for PTSD in residential substance use treatment. Am J Addict. 2023 Sep;32(5):488-496. doi: 10.1111/ajad.13442. Epub 2023 Jun 17.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): May 28, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Written Exposure Therapy
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders; Stress Disorders, Traumatic; Substance-Related Disorders; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: WEST 2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD may be shared with other researchers through a de-identified, secure, electronic data transfer as allowed by the IRB and other regulatory authorities.
• IPD Sharing Time Frame: Interested individuals may inquire after data lock is achieved and the primary outcomes paper has been published from this dataset. Estimated time: 2026

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