CClinicalTrials.gg
CompletedNCT06296940WESTUpdated Jun 10, 2025

Written Exposure 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 2025-06-10.

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

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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?

02

Conditions studied

  • Posttraumatic Stress Disorder
  • Substance Use Disorders

Keywords

  • Written Exposure Therapy
03

Who can participate

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Treatment as Usual (TAU)

    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.

    Behavioral: Treatment as Usual

  • Experimental
    TAU + Written Exposure Therapy (WET)

    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.

    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.

  • 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 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)

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pre/post intervention window (approximately 3 weeks)

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 randomization)

06

Study locations

1 site
  • Maryland Treatment Centers
    Baltimore, Maryland 21229, United States
07

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.

08

Registry details

Key details

Study ID
NCT06296940
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
Mar 6, 2024
Start date
Dec 1, 2022
Primary completion
May 28, 2024
Completion
May 31, 2024
Last update
Jun 10, 2025

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 Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion