- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07108608
- Original Trial
Adaptation of Written Exposure Therapy in Substance Treatment (WEST)
June 24, 2026 updated by: Rebecca Schacht, Potomac Health Foundations
Treating OUD/PTSD in Residential Care: Written Exposure in Substance Treatment (WEST).
The purpose of this pilot non-randomized, uncontrolled clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) as adapted for use 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 question the study aims to answer is: 1) Is the delivery of adapted WET feasible and acceptable in short term residential SUD treatment for individuals with severe SUD?
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21229
- Maryland Treatment Centers
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 English speaking.
Exclusion Criteria:
- Inability to give informed consent for any reason (e.g., cognitive impairment)
- Presence of acute psychosis or suicidality that would interfere with study participation
- planning to leave residential treatment before WEST could realistically be completed as determined by the investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TAU + Adapted Written Exposure Therapy (WET)
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.
|
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.
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD symptom reduction
Time Frame: Pre-WEST intervention; post-WEST intervention (approximately 14 days after randomization, but will vary based on when participants complete the intervention); 4-weeks post enrollment; 8-weeks post enrollment; 12-weeks post enrollment.
|
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-WEST intervention; post-WEST intervention (approximately 14 days after randomization, but will vary based on when participants complete the intervention); 4-weeks post enrollment; 8-weeks post enrollment; 12-weeks post enrollment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of WET delivered in residential SUD treatment context
Time Frame: Up to 4 weeks, or until the participant discharges from residential treatment (whichever comes first).
|
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
Time Frame: Collected post intervention window (approximately 3 weeks from enrollment)
|
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 enrollment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2025
Primary Completion (Actual)
June 22, 2026
Study Completion (Actual)
June 22, 2026
Study Registration Dates
First Submitted
July 29, 2025
First Submitted That Met QC Criteria
August 5, 2025
First Posted (Actual)
August 7, 2025
Study Record Updates
Last Update Posted (Actual)
June 29, 2026
Last Update Submitted That Met QC Criteria
June 24, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WEST 3.0
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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