Clinical trial NCT05327504: Written Exposure Therapy for Veterans With SUD and PTSD
Official title: Written Exposure Therapy (WET) as a Brief Trauma Treatment for Veterans With Co-occurring Substance Use Disorders and PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Posttraumatic Stress Disorder
Keywords: Addiction
Trauma and Stress Related Disorders
Substance Use Disorder
PTSD
Comorbidity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-04-14
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial within a Substance Use Disorder (SUD) clinic to evaluate whether treatment as usual (TAU) plus Written Exposure Therapy (WET) is superior to TAU augmented by a neutral topic writing on both PTSD and addiction outcomes for Veterans who present to SUD treatment with comorbid SUD/PTSD.
Primary purpose: TREATMENT

Brief summary: The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). While SUD treatment programs traditionally do not address PTSD, effective trauma treatments have been used successfully among those with substance use comorbidities. WET is a brief trauma-focused intervention shown to effectively treat PTSD. In a recent acceptability and feasibility pilot study among Veterans with co-occurring SUD and PTSD, results showed a decrease in PTSD symptoms among participants receiving WET. The goal of the present study is to improve outcomes for Veterans who present for SUD treatment with comorbid SUD/PTSD.

Detailed description: This study is a randomized clinical trial within a Substance Use Disorder (SUD) specialty clinic to evaluate whether treatment as usual (TAU) plus Written Exposure Therapy (WET) is superior to TAU augmented by a neutral topic writing condition on both PTSD and addiction outcomes for Veterans in SUD treatment. Veterans with a current diagnosis of SUD and comorbid PTSD will be randomized to either WET plus TAU or TAU augmented by a neutral topic writing condition. During the first writing session, participants will be asked to write about either a personal traumatic experience (WET) or a neutral topic (control). In sessions 2 through 5, participants will again meet with the study therapist for 45 minutes (maintaining the same writing condition as assigned in session one). Measures of trauma symptoms, distress, and mood will be collected at each writing session, with additional assessments at baseline, at post-treatment (following 5 writing sessions), 8-weeks, and 12-weeks post-baseline assessment. The primary aim of this study is to examine whether WET augmentation of TAU improves trauma symptoms for Veterans with SUD and PTSD who are receiving outpatient SUD treatment compared to TAU with a neutral writing control. The secondary aim will examine whether WET improves SUD outcomes for Veterans with comorbid PTSD compared to TAU with a neutral writing control. If results prove promising, they will support WET as an effective brief, cost efficient, easy to disseminate, adjunct to current SUD treatment for Veterans with comorbid PTSD.

Eligibility criteria: Inclusion Criteria:

* Veterans ages 18 years old or older;
* Meets DSM-5 criteria for at least one substance use disorder (SUD);
* Meets DSM-5 criteria for PTSD;
* Approved for SUD treatment at VA Connecticut Healthcare System.

Exclusion Criteria:

* Veterans who meet current criteria for schizophrenia, schizophrenia-type disorders, or unmedicated mania or bipolar disorder as determined by QuickSCID-5;
* current suicidal or homicidal risks necessitating a higher level of care;
* Veterans who have received an Evidence-Based Psychotherapy for PTSD protocol within the past 6 months;
* Problems that would prevent a participant from completing the writing intervention or study assessments (e.g., illiteracy). To assess for literacy, participants will read parts of the consent out loud.

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 8-week Post-Baseline Follow-up
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 12-week Post-Baseline Follow-up
Secondary outcomes:
measure: Timeline Follow-Back (TLFB)
timeFrame: 8-week Post-Baseline Follow-up
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Sarah Meshberg-Cohen, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References: