Posttraumatic Stress Disorder (PTSD)WESTNCT07782268
Written Exposure in Substance Treatment (WEST 3.0): Randomized Controlled Trial
A study testing Written Exposure Therapy and Treatment as Usual in people with Posttraumatic Stress Disorder (PTSD) and Substance Use Disorder (SUD), run by Potomac Health Foundations at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD), Substance Use Disorder (SUD)
- What is being tested?
- Written Exposure Therapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Maryland Treatment Centers
Baltimore, Maryland, 21229
Kevin Wenzel, PhD, 410-233-1400, kwenzel@marylandtreatment.org
Marc Fishman, MD, 410-233-1400, mfishman@marylandtreatment.org
About this study
Official title: 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.
- Being tested
- Written Exposure Therapy, Treatment as Usual
- Keywords
- Written Exposure Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure TherapyBehavioural
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 UsualBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Written Exposure Therapy |
| TAU | Active comparator | Treatment as Usual will include a variety of standard care services offered in short term residential treatment. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Secondary outcomes (13)
Days of Substance Use
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.
Measured: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Substance Use Exposure
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.
Measured: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Anxiety Symptoms
General Anxiety Disorder (GAD-7) will assess symptoms of anxiety.
Measured: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9) will assess depressive symptoms.
Measured: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Recovery Capital
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.
Measured: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Treatment Outcomes
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.
Measured: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Moral Injury
Moral Injury and Distress Scale (MIDS) will assess exposure to potentially morally injurious events and the possible impacts of moral injury.
Measured: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Emotion Regulation
Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) will assess emotion regulation and distress tolerance skills
Measured: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Self Efficacy
Trauma Coping Self Efficacy (CSE-T) will assess participants' perceptions of their ability to cope with trauma related distress
Measured: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Discharge related outcomes
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.
Measured: 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
Barriers to Treatment Participation Scale (BTPS): A WEST specific version of the measure will assess barriers to patient engagement in WEST.
Measured: 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
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).
Measured: 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Physical Pain
Short-Form Health Survey (SF-12): two items from this measure will assess participant-reported physical pain.
Measured: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Potomac Health Foundations
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore County
- Responsible party
- Principal investigator, Rebecca Schacht, Potomac Health Foundations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782268
- Sponsor's protocol ID
- WEST 3.0 RCT
- Acronym
- WEST
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD may be shared with other researchers through a de-identified, secure, electronic data transfer as allowed by the IRB and other regulatory authorities.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating OUD/PTSD in Residential Care: Written Exposure in Substance Treatment (WEST)
- ClinicalTrials.gov ID
- NCT07782268
- Acronym / sponsor ID
- WEST / WEST 3.0 RCT
- Keywords
- Written Exposure Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Potomac Health FoundationsUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore County
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU + Adapted Written Exposure Therapy (WET) | Experimental | Behavioral: Written Exposure TherapyParticipants 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. |
| TAU | Active comparator | Behavioral: Treatment as UsualTreatment as Usual will include a variety of standard care services offered in short term residential treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written Exposure TherapyWritten 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. | Behavioural | TAU + Adapted Written Exposure Therapy (WET) |
| Treatment as UsualTreatment 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) | Behavioural | TAU |
Primary outcome
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.
13 secondary outcomes
Days of Substance Use
Time frame: 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.
Anxiety Symptoms
Time frame: 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.
Recovery Capital
Time frame: 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.
Moral Injury
Time frame: 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.
Self Efficacy
Time frame: 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)
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.
Adverse Events
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Yes. IPD may be shared with other researchers through a de-identified, secure, electronic data transfer as allowed by the IRB and other regulatory authorities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy and Treatment as Usual in people with Posttraumatic Stress Disorder (PTSD) and Substance Use Disorder (SUD), run by Potomac Health Foundations at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Schacht, PhD (410-455-5626, rschacht@umbc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptom reduction (time frame: Pre-WEST intervention; 4 weeks post-randomization, 8 weeks post-randomization, and 12 weeks post-randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.