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NCT05536908 · ClinicalTrials.gov registry record · NA
Evaluating Supplementing Residential Substance Use Treatment With Written Exposure Therapy for Veterans With Post Traumatic Stress Disorder (PTSD) and Substance Use Disorders (SUD)
A NA study of PTSD and Substance Use Disorders, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT05536908: Completed NA study of PTSD and Substance Use Disorders, sponsored by VA Office of Research and Development.
NCT05536908 is a NA study of PTSD and Substance Use Disorders that has completed, run by VA Office of Research and Development. The registered enrollment target is 56 participants, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05536908, a NA study of PTSD and Substance Use Disorders, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
Posttraumatic Stress Disorder (PTSD) and Substance Use Disorder (SUD) are highly comorbid, and comorbidity increases risk for poor functional outcomes. Risks for poor quality of life and suicide increase further for those with co-occurring PTSD and SUD diagnoses as compared to either condition alone, with suicide attempt rates three times higher for Veterans with alcohol use disorder and PTSD (Norman, Haller, Hamblen, Southwick \& Pietrzak, 2018). For patients with PTSD-SUD, there is evidence of greater PTSD symptom severity and poorer SUD treatment outcomes (e.g., Back et al., 2000), as well as higher rates of homelessness and disability (Bowe \& Rosenheck, 2015). PTSD-SUD treatments have shown promising reductions in PTSD and SUD symptoms (Flanagan, Korte, Killeen \& Back,2016). Yet, there are still major challenges in widely implementing concurrent or single-target gold-standard treatments for this population, especially with rural veterans where care access may be limited (e.g., Flanagan et al., 2016). Written Exposure Therapy (WET) is a front-line, brief and effective treatment for PTSD that addresses some of the challenges posed by other gold-standard treatments. This project 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). The preliminary effects of the treatment during the program, and at one month and 3-month follow-up periods will also be examined, with particular attention to rates of substance use, homelessness, treatment attendance, treatment completion, quality of life, suicidality, and PTSD and depression symptoms. Veterans enrolled in the residential substance use disorder clinic will be recruited for screening into the study. Those that meet criteria for PTSD will be randomized into one of two treatment arms: Treatment as Usual (TAU: DOM SUD) and Written Exposure Therapy in a residential SUD pro
Primary Outcome
Standardized patient treatment satisfaction measure, used in substance use treatment settings (Kelly et al, 2018). 8 items measuring satisfaction with treatment, Likert scales from 1 (low satisfaction) to 4 (high satisfaction). Total scores range from 8 to 32, with higher scores indicating greater satisfaction. High concurrent validity and internal consistency. Average item scores of 3 or higher indicate satisfaction with treatment. Completed by participants at the conclusion of 28 day program.
Conditions Studied
Interventions
- BEHAVIORAL Treatment as Usual
- BEHAVIORAL Residential Written Exposure Therapy
Study Locations (1)
Virginia
- Salem VA Medical Center, Salem, VA - Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2023-06-22 |
| Est. Completion | 2026-01-15 |
| Phase | NA |
What the finished NCT05536908 record still lists
NCT05536908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which Treatment as Usual is the first listed.
NCT05536908 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05536908 about?
NCT05536908 is a clinical study titled "Evaluating Supplementing Residential Substance Use Treatment With Written Exposure Therapy for Veterans With Post Traumatic Stress Disorder (PTSD) and Substance Use Disorders (SUD)". Posttraumatic Stress Disorder (PTSD) and Substance Use Disorder (SUD) are highly comorbid, and comorbidity increases risk for poor functional outcomes. Risks for poor quality of life and suicide increase further for those with co-occurring PTSD and SUD diagnoses as compared to either condition alone...
What is the current status of trial NCT05536908?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2023-06-22. Estimated completion is 2026-01-15.
What conditions does trial NCT05536908 study?
This clinical trial studies the following conditions: PTSD, Substance Use Disorders.
What interventions are being tested in trial NCT05536908?
The interventions under investigation include: Treatment as Usual (BEHAVIORAL), Residential Written Exposure Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT05536908?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05536908 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05536908's enrollment target sits among peer trials
56 94th of 154 higher than 61 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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