NCT07108608

Brief 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?

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Aug 2025Sep 2026

First Submitted

Initial submission to the registry

July 29, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

July 29, 2025

Last Update Submit

August 5, 2025

Conditions

Keywords

Written Exposure Therapy

Outcome Measures

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.

    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 (2)

  • Feasibility of WET delivered in residential SUD treatment context

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

  • Acceptability of WET delivered in residential SUD treatment context

    Collected post intervention window (approximately 3 weeks from enrollment)

Study Arms (1)

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.

Behavioral: Written Exposure TherapyBehavioral: Treatment as Usual

Interventions

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.

TAU + Adapted Written Exposure Therapy (WET)

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)

TAU + Adapted Written Exposure Therapy (WET)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 English speaking.

You may not qualify if:

  • Inability to give informed consent 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maryland Treatment Centers

Baltimore, Maryland, 21229, United States

Location

Related Publications (1)

  • 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.

    PMID: 37329251BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSubstance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersChemically-Induced Disorders

Central Study Contacts

Rebecca Schacht, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Investigators are conducting an uncontrolled trial of approximately 20 subjects who will be assigned to adapted Written Exposure Therapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliated Research Scientist

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 7, 2025

Study Start

August 25, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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

Locations