Written Exposure in Substance Treatment

Posttraumatic Stress Disorder Clinical Trial

— WEST  

Official title:

Project WEST (Written Exposure in Substance Treatment) Part 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296940
• Other study ID #: WEST 2.0
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Potomac Health Foundations
• Contact: Rebecca Schacht, PhD
• Phone: 410.455.562
• Email: rschacht[@]umbc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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)

Locations

Country	Name	City	State
United States	Maryland Treatment Centers	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Potomac Health Foundations	University of Maryland, Baltimore County

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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)