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Written Exposure Therapy for PTSD in Veterans with Substance Use Disorders (WET Trial)
N/A
Recruiting
Led By Sarah Meshberg-Cohen, PhD MS BS
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
Meets DSM-5 criteria for PTSD;
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-week post-baseline follow-up
Awards & highlights
WET Trial Summary
This trial will test the efficacy of written exposure therapy (WET) for treating posttraumatic stress disorder (PTSD) in veterans with substance use disorder (SUD) who are already engaged in SUD treatment. WET is a brief trauma-focused intervention that has been shown to be effective for treating PTSD. The goal of this study is to improve outcomes for veterans with comorbid SUD/PTSD.
Who is the study for?
This trial is for Veterans approved for substance use disorder (SUD) treatment at VA Connecticut Healthcare System, aged 18 or older, who have both SUD and PTSD. It's not open to those with schizophrenia-type disorders, current severe suicidal or homicidal risks, recent PTSD psychotherapy within the past 6 months, or literacy issues.Check my eligibility
What is being tested?
The study tests Written Exposure Therapy (WET), a brief trauma-focused intervention aimed at treating PTSD in Veterans with co-occurring SUD. Participants will be compared to those writing on neutral topics to see if WET leads to better outcomes.See study design
What are the potential side effects?
While specific side effects are not listed for this psychological therapy trial, participants may experience discomfort recalling traumatic events during WET sessions which could temporarily increase stress or anxiety levels.
WET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PTSD.
WET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-week post-baseline follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-week post-baseline follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PTSD Checklist for DSM-5 (PCL-5)
Secondary outcome measures
Timeline Follow-Back (TLFB)
WET Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Written Exposure TherapyExperimental Treatment1 Intervention
Written Exposure Therapy (WET) plus Treatment As Usual (TAU). WET is a 5 session, evidence-based trauma-focused written narrative exposure treatment. At each session, patients are instructed to write about the same trauma event and therapists provide feedback about adherence and offer suggestions. The first session includes psychoeducation about PTSD and a treatment rationale prior to general trauma narrative writing instructions, and specific instructions for completing the first writing session, before completing the first writing (30 minutes) session. Participants are instructed to write about the same trauma event at each following session, with an emphasis on delving into their deepest emotions and thoughts, in as much detail as possible, about the event. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant.
Group II: Neutral Topic WritingActive Control1 Intervention
Treatment As Usual (TAU) augmented by a neutral topic writing condition. The neutral topic writing condition involves writing about an assigned topic during each of the five writing sessions. As opposed to writing about trauma, the specific focus of this condition is on writing for 30 minutes about topics related to their life without writing about emotions or opinions. Rather, they are asked to write about specific objects or events in detail, as accurately as possible, and with as much description as possible. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Written Exposure Therapy
2021
Completed Phase 2
~370
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,114 Total Patients Enrolled
Sarah Meshberg-Cohen, PhD MS BSPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a veteran and 18 years old or older.I have been diagnosed with PTSD.You have been diagnosed with a substance use disorder (SUD) according to the DSM-5.I am a veteran who has undergone PTSD therapy in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Written Exposure Therapy
- Group 2: Neutral Topic Writing
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.
Does this research program currently accept new participants?
"Affirmative. The records hosted on clinicaltrials.gov attest that this medical trial, created August 1st 2022 and recently modified September 7th 2022, is actively recruiting applicants. To complete the study it requires 170 participants at a single site."
Answered by AI
How many subjects are enrolled in this experiment?
"Indeed, the information available on clinicaltrials.gov indicates that this medical trial is recruiting participants. It was first posted in early August of 2022 and has since been updated once at the beginning of September. A total of 170 patients are required from 1 location for completion."
Answered by AI
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