Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296186
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-15
Brief Title:
Massed Prolonged Exposure for PTSD in Substance Use Treatment
Sponsor:
Veterans Medical Research Foundation
Organization:
Veterans Medical Research Foundation
Study Overview
Official Title:
Clinical Effectiveness and Implementation of Massed Prolonged Exposure for PTSD Among Veterans in Intensive Outpatient Substance Use Treatment MPE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVAIL
Brief Summary:
The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format multiple sessions weekly is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment The main questions it aims to answer are
Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms
Will it help participants reduce substance use Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week
Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms
Will it help participants reduce substance use Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week
Detailed Description:
Posttraumatic stress disorder PTSD and substance use disorder SUD often co-occur PTSDSUD comorbidity is associated with more severe PTSD worse treatment outcomes for substance use greater suicide risk and worse functioning than having one of these disorders First-line treatments for PTSD particularly Prolonged Exposure Therapy PE are effective in treating PTSD among those with a SUD and delivering these treatments concurrent to SUD programming is recommended by the VADoD Clinical Practice Guidelines While PE is one of the most effective treatment options for PTSD among those with PTSDSUD effects are smaller and dropout is higher than among people with PTSD without a SUD A promising way to enhance outcomes is to offer PE in a massed format M-PE ie multiple sessions per week instead of once weekly M-PE has been shown to be effective in improving PTSD symptoms and substantially reducing dropout in military and Veteran populations Preliminary findings suggest M-PE delivered concurrent to intensive SUD programming is a promising strategy that warrants further study Evaluating the effectiveness of M- PE delivery in of SUD intensive outpatient programming IOP in improving PTSD and other mental health outcomes and reducing dropout as compared to weekly PE delivery W-PE is the necessary next step in this critical research
The primary goal of this project is to determine if a promising way to treat PTSD among those with SUD M-PE will help Veterans with their PTSD symptoms and lead to better treatment completion rates more than PE delivered weekly and if the massed format will reduce substance use comparably to weekly PE among those in intensive SUD treatment The study will also evaluate if M-PE helps Veterans function better and feel less depressed M-PE is a one-on-one talk therapy that is delivered over twelve sessions several times a week The therapy is brief because of the massed format so that it can be delivered at times when lengthy interventions may not be realistic such as military mental health clinics on bases where military personnel may be getting ready to redeploy The research teams preliminary work with Veterans in intensive SUD treatment showed M-PE to lead to improvements in PTSD and depression symptoms with no dropout making this larger evaluation of M-PE compared to PE delivered in the traditional longer weekly format a critical next step The study will accomplish this by randomly assigning participants who are in intensive SUD treatment to receive either M-PE or W-PE The study will have 200 Veterans who served post 911 go through this study and the entire study is expected to take four years to complete The study will run the study across four VAs San Diego Tampa Chicago and Atlanta
The primary goal of this project is to determine if a promising way to treat PTSD among those with SUD M-PE will help Veterans with their PTSD symptoms and lead to better treatment completion rates more than PE delivered weekly and if the massed format will reduce substance use comparably to weekly PE among those in intensive SUD treatment The study will also evaluate if M-PE helps Veterans function better and feel less depressed M-PE is a one-on-one talk therapy that is delivered over twelve sessions several times a week The therapy is brief because of the massed format so that it can be delivered at times when lengthy interventions may not be realistic such as military mental health clinics on bases where military personnel may be getting ready to redeploy The research teams preliminary work with Veterans in intensive SUD treatment showed M-PE to lead to improvements in PTSD and depression symptoms with no dropout making this larger evaluation of M-PE compared to PE delivered in the traditional longer weekly format a critical next step The study will accomplish this by randomly assigning participants who are in intensive SUD treatment to receive either M-PE or W-PE The study will have 200 Veterans who served post 911 go through this study and the entire study is expected to take four years to complete The study will run the study across four VAs San Diego Tampa Chicago and Atlanta
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None