Written Exposure in Substance Treatment (WEST 3.0): Randomized Controlled Trial

NCT07782268 | Not Yet Recruiting DMC

• 1 other identifier: WEST 3.0 RCT
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current research study is to evaluate the efficacy of the refined Written Exposure in Substance Treatment (WEST) for PTSD among residential SUD patients through a randomized controlled trial. 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. Participants will be randomly assigned to WEST + treatment as usual (TAU) or TAU only. The primary outcome is change in PTSD symptoms from pre-intervention to post-intervention. The secondary outcome will be change in SUD outcomes (e.g., treatment completion, reduced opioid and other drug use) and change in non-PTSD mental health outcomes (e.g., depression) from pre-intervention to post-intervention.

Conditions

Posttraumatic Stress Disorder (PTSD); Substance Use Disorder (SUD)

Keywords

Written Exposure Therapy

Outcome Measures

Primary Outcomes (1)

• PTSD symptom reduction

  PTSD symptom reduction pre/post intervention by treatment arm as measured by he PTSD Checklist for DSM-5 (PCL-5) and the Clinician-Administered PTSD Scale for DSM-5 (CAPS). The PCL-5 is a 20-item self-report questionnaire that yields a total symptom scores ranging from 0-80 with higher scores indicating greater symptomology. The CAPS is a 30-item structured interview that yields a diagnosis of PTSD, a total PTSD symptom severity score, and a severity score for each symptom cluster.

  Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

Secondary Outcomes (13)

• Days of Substance Use

  Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

• Substance Use Exposure

  Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

• Anxiety Symptoms

  Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

• Depressive Symptoms

  Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

• Recovery Capital

  Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

Study Arms (2)

TAU + Adapted Written Exposure Therapy (WET)

EXPERIMENTAL

Participants in this condition receive everything included in TAU plus 5 individual sessions of WET delivered by a therapist. WET has been adapted for delivery in a residential SUD setting according to expert feedback. Sessions average less than 60 minutes and primarily involve writing about the traumatic experience that is guided by the therapist.

Behavioral: Written Exposure Therapy

TAU

ACTIVE COMPARATOR

Treatment as Usual will include a variety of standard care services offered in short term residential treatment.

Behavioral: Treatment as Usual

Interventions

Written Exposure Therapy BEHAVIORAL

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. Further, the investigators have adapted WET for this setting based on stakeholder and expert feedback.

TAU + Adapted Written Exposure Therapy (WET)

Treatment as Usual BEHAVIORAL

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 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)

TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be enrolled in residential SUD treatment at MTC
• meet criteria for PTSD based on the Clinician-Administered PTSD Scale for DSM-5
• be 18 years of age or older
• have sufficient memory of the index trauma to write about it
• be sufficiently able to speak, read, and write in the English language to complete WEST therapy and study assessments.

You may not qualify if:

• Inability to give informed consent for any reason (e.g., cognitive impairment)
• Presence of acute psychosis that would interfere with study participation
• Suicide attempt within the past 3 months
• History of psychiatric hospitalization within the past month
• Presence of any other psychiatric instability or suicidality that would interfere with study participation
• Planning to leave residential treatment before WEST could realistically be completed as determined by the investigator
• Lack of access to a mobile phone after treatment discharge

Sponsors & Collaborators

• Potomac Health Foundations: lead
• University of Maryland, Baltimore County: collaborator

Study Sites (1)

Maryland Treatment Centers

Baltimore, Maryland, 21229, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Central Study Contacts

Rebecca Schacht, PhD

CONTACT

410-455-5626; rschacht@umbc.edu

Kevin Wenzel, PhD

CONTACT

410-233-1400; kwenzel@marylandtreatment.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliated Research Scientist

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)