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Written Exposure Therapy for PTSD and Substance Use Disorders
N/A
Recruiting
Led By Dana Holohan
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 2, 3, 4, 8, 16
Awards & highlights
Study Summary
This trial is designed to examine the feasibility and acceptability of Written Exposure Therapy (WET) delivered to Veterans with comorbid PTSD-SUD while they are completing a 28 day-residential SUD program (DOM SUD).
Who is the study for?
This trial is for veterans enrolled in a residential substance use disorder program at the Salem VAMC who have both PTSD and SUD. It's not open to those currently experiencing a manic episode, with current suicidal intent, previous Written Exposure treatment, or inability to write.Check my eligibility
What is being tested?
The study tests if adding Written Exposure Therapy (WET) to usual substance use disorder treatment helps veterans with PTSD and SUD. Participants are randomly assigned to receive either standard treatment or standard plus WET over five sessions.See study design
What are the potential side effects?
Potential side effects may include emotional distress due to recalling traumatic events during WET sessions. However, specific physical side effects are not mentioned as it's a psychological intervention.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 1, 2, 3, 4, 8, 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 2, 3, 4, 8, 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of Intervention Measure (AIM)
Change in Brief Addition Monitor (BAM)
Change in Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
+9 moreSecondary outcome measures
Change in Cravings
Drug Screen status
Homelessness Status
+1 moreOther outcome measures
Columbia Suicide Severity Rating Scale
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: resWETExperimental Treatment1 Intervention
Residential Written Exposure Therapy (resWET): Treatment as Usual (TAU) plus 5-individual Written Exposure Therapy (WET) sessions (40-60 min each; Marx & Sloan, 2019) twice a week for two weeks and once a week for the final session, administered by WET trained psychologists, social workers, or postdoctoral residents. Treatment instructions are read, patients write for 30 minutes, and the writing is briefly processed. No formal written homework is required.
Group II: Treatment as Usual (TAU)Active Control1 Intervention
Treatment as Usual (DOM SUD): The DOM SUD (TAU) is a 24-bed intensive substance use disorder (SUD) residential program with a typical 28-day length of stay. The program focuses on evidence-based treatments for SUD such as Cognitive-Behavioral Therapy, Motivational Enhancement Therapy, Medication Assisted Treatment, and Contingency Management therapy. Patients diagnosed with Post-traumatic Stress Disorder (PTSD) are typically referred to outpatient PTSD treatment following DOM SUD and often attend Seeking Safety during the program. Most of the programming is group-based though Veterans also have weekly individual case management appointments.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,234 Total Patients Enrolled
VA Boston Healthcare SystemFED
68 Previous Clinical Trials
970,402 Total Patients Enrolled
Center for Biostatistics and Health Data ScienceUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently experiencing a manic episode.I have been diagnosed with both a substance use disorder and PTSD.
Research Study Groups:
This trial has the following groups:- Group 1: resWET
- Group 2: Treatment as Usual (TAU)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the prime aims of this trial?
"This study, which will be measured over the course of Week 1, 4, 8 and 16 aims to evaluate Treatment Completion rates. Secondary goals include assessing Homelessness Status via chart review in medical records; Drug Screen status throughout three months post-treatment; and Change in Cravings using a 5 point Likert scale from no craving (1) to extreme craving (5)."
Answered by AI
Is this experiment open to new participants at the moment?
"The information published on clinicaltrials.gov indicates that this study is not actively recruiting patients any longer. The trial was initially uploaded on December 1st 2022 and most recently modified on September 16th 2022, yet there are still 1429 other active trials accepting candidates at the moment."
Answered by AI
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