Substance Use DisordersWETNCT05327504
Written Exposure Therapy for Veterans With SUD and PTSD
A study testing Written Exposure Therapy and Neutral Topic Writing in people with Substance Use Disorders and Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Posttraumatic Stress Disorder
- What is being tested?
- Written Exposure Therapy and Neutral Topic Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to 30 Jun 2027
- 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
- Veterans ages 18 years old or older;
- Meets DSM-5 criteria for at least one substance use disorder (SUD);
- Meets DSM-5 criteria for PTSD;
- Approved for SUD treatment at VA Connecticut Healthcare System.
Who cannot join
- Veterans who meet current criteria for schizophrenia, schizophrenia-type disorders, or unmedicated mania or bipolar disorder as determined by QuickSCID-5;
- current suicidal or homicidal risks necessitating a higher level of care;
- Veterans who have received an Evidence-Based Psychotherapy for PTSD protocol within the past 6 months;
- Problems that would prevent a participant from completing the writing intervention or study assessments (e.g., illiteracy). To assess for literacy, participants will read parts of the consent out loud.
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, 1 recruiting
- Recruiting
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
Amanda O'Brien, MA, 203-932-5711 ext. 1-4841, amanda.obrien3@va.gov
Diana DeNegre, (203) 932-5711 ext. 5217, diana.denegre@yale.edu
About this study
Official title: Written Exposure Therapy (WET) as a Brief Trauma Treatment for Veterans With Co-occurring Substance Use Disorders and PTSD
The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). While SUD treatment programs traditionally do not address PTSD, effective trauma treatments have been used successfully among those with substance use comorbidities. WET is a brief trauma-focused intervention shown to effectively treat PTSD. In a recent acceptability and feasibility pilot study among Veterans with co-occurring SUD and PTSD, results showed a decrease in PTSD symptoms among participants receiving WET. The goal of the present study is to improve outcomes for Veterans who present for SUD treatment with comorbid SUD/PTSD.
Read the detailed description
This study is a randomized clinical trial within a Substance Use Disorder (SUD) specialty clinic to evaluate whether treatment as usual (TAU) plus Written Exposure Therapy (WET) is superior to TAU augmented by a neutral topic writing condition on both PTSD and addiction outcomes for Veterans in SUD treatment. Veterans with a current diagnosis of SUD and comorbid PTSD will be randomized to either WET plus TAU or TAU augmented by a neutral topic writing condition. During the first writing session, participants will be asked to write about either a personal traumatic experience (WET) or a neutral topic (control). In sessions 2 through 5, participants will again meet with the study therapist for 45 minutes (maintaining the same writing condition as assigned in session one). Measures of trauma symptoms, distress, and mood will be collected at each writing session, with additional assessments at baseline, at post-treatment (following 5 writing sessions), 8-weeks, and 12-weeks post-baseline assessment. The primary aim of this study is to examine whether WET augmentation of TAU improves trauma symptoms for Veterans with SUD and PTSD who are receiving outpatient SUD treatment compared to TAU with a neutral writing control. The secondary aim will examine whether WET improves SUD outcomes for Veterans with comorbid PTSD compared to TAU with a neutral writing control. If results prove promising, they will support WET as an effective brief, cost efficient, easy to disseminate, adjunct to current SUD treatment for Veterans with comorbid PTSD.
- Being tested
- Written Exposure Therapy, Neutral Topic Writing
- Keywords
- Addiction, Trauma and Stress Related Disorders, Substance Use Disorder, PTSD, Comorbidity
- Medical subject headings
- Substance-Related Disorders, Stress Disorders, Post-Traumatic, Behavior, Addictive, Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure TherapyBehavioural
Also called Trauma-focused Treatment
Written Exposure Therapy is a 5 session treatment in which individuals write about their trauma event in a specified manner.
Neutral Topic WritingBehavioural
Also called Control Writing
Treatment as Usual augmented by 5 sessions of Neutral Topic Writing which involves writing about specific objects (e.g., what they have eaten over the past week) or events (e.g., what they did since yesterday) in detail without discussing thoughts or feelings.
| Study group | Role | What they receive |
|---|---|---|
| Written Exposure Therapy | Experimental | Written Exposure Therapy (WET) plus Treatment As Usual (TAU). WET is a 5 session, evidence-based trauma-focused written narrative exposure treatment. At each session, patients are instructed to write about the same trauma event and therapists provide feedback about adherence and offer suggestions. The first session includes psychoeducation about PTSD and a treatment rationale prior to general trauma narrative writing instructions, and specific instructions for completing the first writing session, before completing the first writing (30 minutes) session. Participants are instructed to write about the same trauma event at each following session, with an emphasis on delving into their deepest emotions and thoughts, in as much detail as possible, about the event. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant. Receives: Behavioral: Written Exposure Therapy |
| Neutral Topic Writing | Active comparator | Treatment As Usual (TAU) augmented by a neutral topic writing condition. The neutral topic writing condition involves writing about an assigned topic during each of the five writing sessions. As opposed to writing about trauma, the specific focus of this condition is on writing for 30 minutes about topics related to their life without writing about emotions or opinions. Rather, they are asked to write about specific objects or events in detail, as accurately as possible, and with as much description as possible. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant. Receives: Behavioral: Neutral Topic Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL scores will be collected based upon symptoms experienced in the past month at Baseline as well as each Post-Baseline Follow-up (8-weeks and 12-weeks), while the weekly PCL-5 will be administered at each of the five writing sessions and post-treatment (after 5 writing sessions) assessment. PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity.
Measured: 8-week Post-Baseline Follow-up
PTSD Checklist for DSM-5 (PCL-5)
PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL scores will be collected based upon symptoms experienced in the past month at Baseline as well as each Post-Baseline Follow-up (8-weeks and 12-weeks), while the weekly PCL-5 will be administered at each of the five writing sessions and post-treatment (after 5 writing sessions) assessment. PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity.
Measured: 12-week Post-Baseline Follow-up
Secondary outcomes (1)
Timeline Follow-Back (TLFB)
Timeline Follow-Back (TLFB) will be provided at baseline, and at post-treatment (after 5 writing sessions), 8-week, and 12-week post-baseline follow-up. Calendar-based interviews using the Timeline Follow-Back (TLFB) method will document the frequency of drug and alcohol use for the 3 months prior to baseline assessment, and during the writing sessions (taken at post-treatment follow-up), 8-week, and 12-week post-baseline follow-up. Following baseline, the TLFB will capture days since last assessment (e.g., days between baseline and post-treatment, post-treatment, and 8-weeks, and 8- to 12-week follow-up). Higher numbers of days of use will equal higher substance use.
Measured: 8-week Post-Baseline Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start26 Sep 2022
- Primary completion12 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
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 Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Randomized clinical trial within a Substance Use Disorder (SUD) clinic to evaluate whether treatment as usual (TAU) plus Written Exposure Therapy (WET) is superior to TAU augmented by a neutral topic writing on both PTSD and addiction outcomes for Veterans who present to SUD treatment with comorbid SUD/PTSD.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sarah Meshberg-Cohen, PhD MS BS, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327504
- Sponsor's protocol ID
- MHBP-010-21F
- Acronym
- WET
- Status last verified
- Feb 2026
- First submitted
- 6 Apr 2022
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, anonymized dataset will be created. This dataset may be shared with other investigators, upon written request, under a data use agreement prohibiting the recipient from identifying or re-de-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The data sharing agreement will also restrict redistribution to third parties and proper acknowledgment of the data source. These datasets will be shared per guidelines provided by VACHS Information Security Officer.
Publications
Meshberg-Cohen S, Cook JM, Bin-Mahfouz A, Petrakis IL. Written exposure therapy for veterans with co-occurring substance use disorders and PTSD: Study design of a randomized clinical trial. Contemp Clin Trials. 2024 Apr;139:107475. doi: 10.1016/j.cct.2024.107475. Epub 2024 Feb 15.
PubMed 38365173
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Written Exposure Therapy (WET) as a Brief Trauma Treatment for Veterans With Co-occurring Substance Use Disorders and PTSD
- ClinicalTrials.gov ID
- NCT05327504
- Acronym / sponsor ID
- WET / MHBP-010-21F
- Keywords
- Addiction, Trauma and Stress Related Disorders, Substance Use Disorder, PTSD, Comorbidity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 12 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Apr 2022 (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 proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). While SUD treatment programs traditionally do not address PTSD, effective trauma treatments have been used successfully among those with substance use comorbidities. WET is a brief trauma-focused intervention shown to effectively treat PTSD. In a recent acceptability and feasibility pilot study among Veterans with co-occurring SUD and PTSD, results showed a decrease in PTSD symptoms among participants receiving WET. The goal of the present study is to improve outcomes for Veterans who present for SUD treatment with comorbid SUD/PTSD.
Detailed description
This study is a randomized clinical trial within a Substance Use Disorder (SUD) specialty clinic to evaluate whether treatment as usual (TAU) plus Written Exposure Therapy (WET) is superior to TAU augmented by a neutral topic writing condition on both PTSD and addiction outcomes for Veterans in SUD treatment. Veterans with a current diagnosis of SUD and comorbid PTSD will be randomized to either WET plus TAU or TAU augmented by a neutral topic writing condition. During the first writing session, participants will be asked to write about either a personal traumatic experience (WET) or a neutral topic (control). In sessions 2 through 5, participants will again meet with the study therapist for 45 minutes (maintaining the same writing condition as assigned in session one). Measures of trauma symptoms, distress, and mood will be collected at each writing session, with additional assessments at baseline, at post-treatment (following 5 writing sessions), 8-weeks, and 12-weeks post-baseline assessment. The primary aim of this study is to examine whether WET augmentation of TAU improves trauma symptoms for Veterans with SUD and PTSD who are receiving outpatient SUD treatment compared to TAU with a neutral writing control. The secondary aim will examine whether WET improves SUD outcomes for Veterans with comorbid PTSD compared to TAU with a neutral writing control. If results prove promising, they will support WET as an effective brief, cost efficient, easy to disseminate, adjunct to current SUD treatment for Veterans with comorbid PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial within a Substance Use Disorder (SUD) clinic to evaluate whether treatment as usual (TAU) plus Written Exposure Therapy (WET) is superior to TAU augmented by a neutral topic writing on both PTSD and addiction outcomes for Veterans who present to SUD treatment with comorbid SUD/PTSD.
| Arm | Type | Receives |
|---|---|---|
| Written Exposure Therapy | Experimental | Behavioral: Written Exposure TherapyWritten Exposure Therapy (WET) plus Treatment As Usual (TAU). WET is a 5 session, evidence-based trauma-focused written narrative exposure treatment. At each session, patients are instructed to write about the same trauma event and therapists provide feedback about adherence and offer suggestions. The first session includes psychoeducation about PTSD and a treatment rationale prior to general trauma narrative writing instructions, and specific instructions for completing the first writing session, before completing the first writing (30 minutes) session. Participants are instructed to write about the same trauma event at each following session, with an emphasis on delving into their deepest emotions and thoughts, in as much detail as possible, about the event. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant. |
| Neutral Topic Writing | Active comparator | Behavioral: Neutral Topic WritingTreatment As Usual (TAU) augmented by a neutral topic writing condition. The neutral topic writing condition involves writing about an assigned topic during each of the five writing sessions. As opposed to writing about trauma, the specific focus of this condition is on writing for 30 minutes about topics related to their life without writing about emotions or opinions. Rather, they are asked to write about specific objects or events in detail, as accurately as possible, and with as much description as possible. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veterans ages 18 years old or older;
- Meets DSM-5 criteria for at least one substance use disorder (SUD);
- Meets DSM-5 criteria for PTSD;
- Approved for SUD treatment at VA Connecticut Healthcare System.
Key exclusion criteria (4 listed)
- Veterans who meet current criteria for schizophrenia, schizophrenia-type disorders, or unmedicated mania or bipolar disorder as determined by QuickSCID-5;
- current suicidal or homicidal risks necessitating a higher level of care;
- Veterans who have received an Evidence-Based Psychotherapy for PTSD protocol within the past 6 months;
- Problems that would prevent a participant from completing the writing intervention or study assessments (e.g., illiteracy). To assess for literacy, participants will read parts of the consent out loud.
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 TherapyAlso: Trauma-focused TreatmentWritten Exposure Therapy is a 5 session treatment in which individuals write about their trauma event in a specified manner. | Behavioural | Written Exposure Therapy |
| Neutral Topic WritingAlso: Control WritingTreatment as Usual augmented by 5 sessions of Neutral Topic Writing which involves writing about specific objects (e.g., what they have eaten over the past week) or events (e.g., what they did since yesterday) in detail without discussing thoughts or feelings. | Behavioural | Neutral Topic Writing |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: 8-week Post-Baseline Follow-up
PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL scores will be collected based upon symptoms experienced in the past month at Baseline as well as each Post-Baseline Follow-up (8-weeks and 12-weeks), while the weekly PCL-5 will be administered at each of the five writing sessions and post-treatment (after 5 writing sessions) assessment. PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity.
PTSD Checklist for DSM-5 (PCL-5)
Time frame: 12-week Post-Baseline Follow-up
PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL scores will be collected based upon symptoms experienced in the past month at Baseline as well as each Post-Baseline Follow-up (8-weeks and 12-weeks), while the weekly PCL-5 will be administered at each of the five writing sessions and post-treatment (after 5 writing sessions) assessment. PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity.
1 secondary outcome
Timeline Follow-Back (TLFB)
Time frame: 8-week Post-Baseline Follow-up
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 19 Feb 2026.
- Derived from this study: PubMed 38365173Meshberg-Cohen S, Cook JM, Bin-Mahfouz A, Petrakis IL. Written exposure therapy for veterans with co-occurring substance use disorders and PTSD: Study design of a randomized clinical trial. Contemp Clin Trials. 2024 Apr;139:107475. doi: 10.1016/j.cct.2024.107475. Epub 2024 Feb 15.
- Individual participant dataSharing planned: Yes. De-identified, anonymized dataset will be created. This dataset may be shared with other investigators, upon written request, under a data use agreement prohibiting the recipient from identifying or re-de-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. The data sharing agreement will also restrict redistribution to third parties and proper acknowledgment of the data source. These datasets will be shared per guidelines provided by VACHS Information Security Officer.
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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.
Sarah Meshberg-Cohen, PhD MS BS principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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 Neutral Topic Writing in people with Substance Use Disorders and Posttraumatic Stress Disorder, run by VA Office of Research and Development 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 Feb 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 Vera Bici, BA ((203) 932-5711 ext. 15448, Vera.Bici@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: 8-week Post-Baseline Follow-up). The study lists 2 primary outcomes in all. 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 NCT05327504, 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 19 Feb 2026.