ClinicalTrials.gg
CompletedNCT07108608WESTUpdated Jun 29, 2026

Adaptation of Written Exposure Therapy in Substance Treatment

An interventional study of Written Exposure Therapy and Treatment as Usual in Posttraumatic Stress Disorder and Substance Use Disorders, sponsored by Potomac Health Foundations. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Potomac Health Foundations · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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?

02

Conditions studied

  • Posttraumatic Stress Disorder
  • Substance Use Disorders

Keywords

  • Written Exposure Therapy
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In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's enrollment of 26 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

Potomac Health Foundations is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Enrolled in residential SUD treatment at MTC
  • Meet criteria for PTSD based on the Clinician-Administered PTSD Scale for
  • Be 18 years of age or older
  • Have sufficient memory of the index trauma to write about it
  • Be English speaking.

Exclusion criteria

Exclusion Criteria:

  • Inability to give 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • 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 · Behavioral: Treatment as Usual

Interventions

  • BehavioralWritten 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.

  • BehavioralTreatment 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)

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What researchers measure

Primary outcomes

  1. PTSD symptom reduction

    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.

    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.

Secondary outcomes

  1. 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

    Time frame: Up to 4 weeks, or until the participant discharges from residential treatment (whichever comes first).

  2. 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.

    Time frame: Collected post intervention window (approximately 3 weeks from enrollment)

07

Study locations

1 site
  • Maryland Treatment Centers
    Baltimore, Maryland 21229, United States
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References and documents

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 ↗

Individual participant data

Plan to share: 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.

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

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2025 to primary completion in Jun 2026, 7 months.

Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 7 months is below that.

Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2025
First posted
Aug 7, 2025
StartActual
Nov 21, 2025
Primary completionActual
Jun 22, 2026
CompletionActual
Jun 22, 2026
Last update
Jun 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07108608
Lead sponsor
Potomac Health Foundations
Collaborators
University of Maryland, Baltimore County
Responsible party
Rebecca Schacht (Affiliated Research Scientist, Potomac Health Foundations) — Principal investigator
First posted
Aug 7, 2025
Start date
Nov 21, 2025
Primary completion
Jun 22, 2026
Completion
Jun 22, 2026
Last update
Jun 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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