Written Exposure in Substance Treatment

NCT06296940 | Completed

• 1 other identifier: WEST 2.0
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Posttraumatic Stress Disorder; Substance Use Disorders

Keywords

Written Exposure Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Feasibility of WET delivered in residential SUD treatment context

  Up to 4 weeks, or until the participant discharges from residential treatment (whichever comes first).

• Acceptability of WET delivered in residential SUD treatment context

  Collected post intervention window (approximately 3 weeks from randomization)

Study Arms (2)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

TAU + Written Exposure Therapy (WET)

EXPERIMENTAL

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: Written Exposure Therapy; 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.

TAU + 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 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)

TAU + Written Exposure Therapy (WET); Treatment as Usual (TAU)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Maryland Treatment Centers

Baltimore, Maryland, 21229, United States

Location

Related Publications (1)

• 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.

  PMID: 37329251 BACKGROUND

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

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

Model Details: We are conducting a randomized controlled trial of approximately 50 randomized subjects (up to 100 total enrollments) who will be assigned 1:1 to treatment as usual (TAU) or TAU+WET.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: December 1, 2022
• Primary Completion: May 28, 2024
• Study Completion: May 31, 2024
• Last Updated: June 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• 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

Locations

US (1)