Written Exposure in Substance Treatment

NCT ID: NCT06296940

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-05-31

Brief Summary

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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?

Detailed Description

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Conditions

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Posttraumatic Stress Disorder Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type BEHAVIORAL

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)

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.

Group Type EXPERIMENTAL

Written Exposure Therapy

Intervention Type BEHAVIORAL

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 Usual

Intervention Type BEHAVIORAL

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)

Interventions

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Written 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.

Intervention Type BEHAVIORAL

Treatment 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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore County

OTHER

Sponsor Role collaborator

Potomac Health Foundations

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Schacht

Affiliated Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maryland Treatment Centers

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 37329251 (View on PubMed)

Other Identifiers

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WEST 2.0

Identifier Type: -

Identifier Source: org_study_id

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