Written Exposure Therapy for Veterans With SUD and PTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Written Exposure Therapy
BehavioralWritten Exposure Therapy is a 5 session treatment in which individuals write about their trauma event in a specified manner.
Neutral Topic Writing
BehavioralTreatment as Usual augmented by 5 sessions of Neutral Topic Writing which involves writing about specific objects (e.g., what they have eaten over the past week) or events (e.g., what they did since yesterday) in detail without discussing thoughts or feelings.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Written Exposure TherapyExperimental treatment 1 intervention
Group B: Neutral Topic WritingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
PTSD Checklist for DSM-5 (PCL-5)
PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL scores will be collected based upon symptoms experienced in the past month at Baseline as well as each Post-Baseline Follow-up (8-weeks and 12-weeks), while the weekly PCL-5 will be administered at each of the five writing sessions and post-treatment (after 5 writing sessions) assessment. PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity.
Time frame
8-week Post-Baseline Follow-up2
PTSD Checklist for DSM-5 (PCL-5)
PTSD Checklist for DSM-5 (PCL-5) will be used to collect information on PTSD symptoms. The PCL-5 for DSM-5 is a 20-item self-report measure, selected for its dimensional sensitivity, with higher scores reflecting greater PTSD severity. Scoring is based on how much the patient has been bothered by the symptoms on a scale from "0 = not at all" to "4 = extremely." PCL scores will be collected based upon symptoms experienced in the past month at Baseline as well as each Post-Baseline Follow-up (8-weeks and 12-weeks), while the weekly PCL-5 will be administered at each of the five writing sessions and post-treatment (after 5 writing sessions) assessment. PCL-5 total symptom severity scores range from 0 to 80 with higher scores indicating greater PTSD severity.
Time frame
12-week Post-Baseline Follow-upSecondary outcomes
1
Timeline Follow-Back (TLFB)
Timeline Follow-Back (TLFB) will be provided at baseline, and at post-treatment (after 5 writing sessions), 8-week, and 12-week post-baseline follow-up. Calendar-based interviews using the Timeline Follow-Back (TLFB) method will document the frequency of drug and alcohol use for the 3 months prior to baseline assessment, and during the writing sessions (taken at post-treatment follow-up), 8-week, and 12-week post-baseline follow-up. Following baseline, the TLFB will capture days since last assessment (e.g., days between baseline and post-treatment, post-treatment, and 8-weeks, and 8- to 12-week follow-up). Higher numbers of days of use will equal higher substance use.
Time frame
8-week Post-Baseline Follow-upSponsors and contacts
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Source ClinicalTrials.gov