Posttraumatic Stress DisorderWESTNCT06296940
Written Exposure in Substance Treatment
A study testing Written Exposure Therapy and Treatment as Usual in people with Posttraumatic Stress Disorder and Substance Use Disorders, run by Potomac Health Foundations at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Substance Use Disorders
- 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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Treatment Centers
Baltimore, Maryland, 21229
About this study
Official title: Project WEST (Written Exposure in Substance Treatment) Part 2
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?
- 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.
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 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Written Exposure Therapy; Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre/post intervention window (approximately 3 weeks)
Secondary outcomes (2)
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
Measured: Up to 4 weeks, or until the participant discharges from residential treatment (whichever comes first).
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.
Measured: Collected post intervention window (approximately 3 weeks from randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Dec 2022
- Primary completion28 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies 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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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
- NCT06296940
- Sponsor's protocol ID
- WEST 2.0
- Acronym
- WEST
- Status last verified
- Mar 2025
- First submitted
- 28 Feb 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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.
Publications
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.
PubMed 37329251
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project WEST (Written Exposure in Substance Treatment) Part 2
- ClinicalTrials.gov ID
- NCT06296940
- Acronym / sponsor ID
- WEST / WEST 2.0
- Keywords
- Written Exposure Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Potomac Health FoundationsUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore County
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 6 Mar 2024 (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 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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as UsualParticipants 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. |
| TAU + Written Exposure Therapy (WET) | Experimental | Behavioral: Written Exposure Therapy, Behavioral: Treatment as UsualParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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. | Behavioural | TAU + 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 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) | Behavioural | TAU + Written Exposure Therapy (WET), Treatment as Usual (TAU) |
Primary outcome
Efficacy of WET
Time frame: Pre/post intervention window (approximately 3 weeks)
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.
2 secondary outcomes
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).
Acceptability of WET delivered in residential SUD treatment context
Time frame: Collected post intervention window (approximately 3 weeks from randomization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Background: PubMed 37329251Schacht 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Substance Use Disorders, 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 10 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of WET (time frame: Pre/post intervention window (approximately 3 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06296940, which also lists 1 linked publication.
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 10 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.