Written Exposure in Substance Treatment

Not Applicable

Active, not recruiting

• Conditions: Posttraumatic Stress Disorder; Substance Use Disorders
• Interventions: Behavioral: Treatment as Usual; Behavioral: Written Exposure Therapy

• Registration Number: NCT06296940
• Lead Sponsor: Potomac Health Foundations

Brief 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-06
• Primary Completion: 2024-05-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as Usual (TAU)	Treatment as Usual	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.
TAU + Written Exposure Therapy (WET)	Written Exposure Therapy	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.
TAU + Written Exposure Therapy (WET)	Treatment as Usual	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of WET	Pre/post intervention window (approximately 3 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility of WET delivered in residential SUD treatment context	Up to 4 weeks, or until the participant discharges from residential treatment (whichever comes first).	Percentage of participants in the WET arm who were able to complete the treatment (5 sessions) prior to discharge
Acceptability of WET delivered in residential SUD treatment context	Collected post intervention window (approximately 3 weeks from randomization)	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.

Trial Locations

Locations (1)

Maryland Treatment Centers; 🇺🇸 Baltimore, Maryland, United States