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

August 20, 2026 updated by: Rebecca Schacht, Potomac Health Foundations

Treating OUD/PTSD in Residential Care: Written Exposure in Substance Treatment (WEST)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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. Further, the investigators have adapted WET for this setting based on stakeholder and expert feedback.
Active Comparator: TAU
Treatment as Usual will include a variety of standard care services offered in short term residential treatment.
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 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PTSD symptom reduction
Time Frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Days of Substance Use
Time Frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Timeline Follow-back (TLFB) will assess opioid and other substance use in the 30 days prior to residential treatment admission and at all follow-ups. Participants will be shown a reference sheet that describes standard drinks (see attached) to help them more easily recall how many standard drinks they have consumed in the past month.
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Substance Use Exposure
Time Frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Kreek-McHugh-Schuluger-Kellogg scale (KMSK) will assess participants' lifetime and past 30-day exposure to specific substances. The KMSK items assessing past 30-day usage will be administered during all follow up appointments.
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Anxiety Symptoms
Time Frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
General Anxiety Disorder (GAD-7) will assess symptoms of anxiety.
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Depressive Symptoms
Time Frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Patient Health Questionnaire-9 (PHQ-9) will assess depressive symptoms.
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Recovery Capital
Time Frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

Brief Assessment of Recovery Capital (BARC-10) will assess participant-reported areas of recovery capital.

Multidimensional Inventory of Recovery Capital (MIRC): designed to assess the resources a person uses to resolve alcohol or drug problems.
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Treatment Outcomes
Time Frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

Treatment Utilization Self-Report Form: an investigator-created form will collect data on ongoing engagement in SUD treatment, mental health, and hospital services.

Medication Continuity assessment (see participant information document): will track adherence with medications prescribed during treatment, including addiction-related and other psychotropic medications.
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Moral Injury
Time Frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Moral Injury and Distress Scale (MIDS) will assess exposure to potentially morally injurious events and the possible impacts of moral injury.
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Emotion Regulation
Time Frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) will assess emotion regulation and distress tolerance skills
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Self Efficacy
Time Frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Trauma Coping Self Efficacy (CSE-T) will assess participants' perceptions of their ability to cope with trauma related distress
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Discharge related outcomes
Time Frame: Completed during the 4-week follow-up appointment once after the participant discharges from the inpatient unit. If participant is still in inpatient, will be completed at the next follow up appointment after discharge (either 8 or 12-week appointments)
Discharge Chart Abstraction (see attached): An investigator-created form will gather information on inpatient treatment completion status, successful initiation on relapse prevention medications for opioid use disorder and alcohol use disorder, and continuing care referrals made by the inpatient treatment team.
Completed during the 4-week follow-up appointment once after the participant discharges from the inpatient unit. If participant is still in inpatient, will be completed at the next follow up appointment after discharge (either 8 or 12-week appointments)
Barriers to Treatment
Time Frame: This will be administered during the 4-week follow-up appointment. If this measure was not completed during the 4-week follow-up, participants will complete the measure during the 8 or 12-week appointment.
Barriers to Treatment Participation Scale (BTPS): A WEST specific version of the measure will assess barriers to patient engagement in WEST.
This will be administered during the 4-week follow-up appointment. If this measure was not completed during the 4-week follow-up, participants will complete the measure during the 8 or 12-week appointment.
Adverse Events
Time Frame: 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Adverse Events Reporting Form (see participant information document): An investigator- created form used to solicit reporting of any adverse events, additional traumatic exposures, and drug/alcohol overdoses since the last research contact; the traumatic exposure item is taken from the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Physical Pain
Time Frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Short-Form Health Survey (SF-12): two items from this measure will assess participant-reported physical pain.
Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Potomac Health Foundations

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Maryland, Baltimore County

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WEST 3.0 RCT

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.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings