Ignite Creation Date:
2024-05-05 @ 11:27 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01338506
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2011-04-08
Brief Title:
Integrated Treatment of OEFOIF Veterans With PTSD Substance Use Disorders
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Integrated Treatment of Operation Enduring FreedomOperation Iraqi Freedom Veterans With Post-traumatic Stress Disorder and Substance Use Disorders
Status:
COMPLETED
Status Verified Date:
2020-02
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:
COPE
Brief Summary:
In comparison to the general population US military and Veterans are at an increased risk for developing both substance use disorders SUD and Post Traumatic Stress Disorder PTSD Current research has shown that there is a high comorbidity of SUD and PTSD and although there are a number of treatments for SUD and PTSD independently there are very few effective methods to simultaneously treat both disorders Because of this substantial gap in the treatment of both SUDs and PTSD it has become essential to develop a combined treatment that would address and treat both disorders Individuals specifically US military and Veterans with SUDPTSD have unique needs that require a specialized treatment approach This designed approach would employ cognitive-behavioral therapy CBT to treat the SUD in conjunction with Prolonged Exposure therapy to treat the PTSD Prolonged Exposure PE is an empirically supported and evidence-based treatment that is currently regarded as the gold standard psychosocial treatment for PTSD In combination with CBT this treatment would address both disorders in hopes of reducing substance use and PTSD symptomatology
Detailed Description:
As a result of sustained operations in Afghanistan and Iraq there are an increasing number of US military personnel and Veterans at risk of developing both substance use disorders SUDs and Post Traumatic Stress Disorder PTSD If left untreated individuals with SUDs andor PTSD are at risk for other mental health problems eg depression suicidal ideation and attempts physical health problems reduced resiliency lost productivity and familyrelationship impairment While mental health services are in place for US military personnel substantial gaps in the treatment of co-occurring SUDs and PTSD exist and there is little scientific evidence available to guide the provision of care The proposed study directly addresses this knowledge gap by testing the feasibility and preliminary efficacy of an integrative behavioral intervention for the treatment of co-occurring SUDs and PTSD modified for use among US military personnel including National Guard and Reservists who have served in Operation Enduring Freedom andor Operation Iraqi Freedom OEFOIF The intervention called Concurrent Treatment with Prolonged exposure or COPE represents a novel treatment that integrates cognitive-behavioral therapy for SUDs with prolonged exposure therapy for PTSD In earlier studies with civilians COPE has demonstrated efficacy in reducing alcohol and drug use severity PTSD symptoms and associated mental health problems eg depression anxiety In this hybrid Stage IbStage II study we will 1 use a manualized well-tolerated behavioral treatment for SUDs and PTSD COPE 2 employ a two-arm randomized between-groups experimental design COPE versus a modified treatment-as usual TAU and 3 examine standardized repeated dependent measures of clinical outcomes and process variables at 5 time points pre- mid- and post-treatment 3 and 6 month follow-up The proposed project is directly responsive to the mission of the National Institute on Drug Abuse NIDA and the National Institute on Alcohol Abuse and Alcoholism NIAAA in that it seeks to enhance and accelerate research on the prevention and treatment of alcohol and drug use disorders including illicit and prescription drugs and comorbid conditions eg PTSD depression sleep disturbances HIV risk behaviors The findings of this study will provide empirical evidence to inform policies and programs to better serve the needs of US military personnel Veterans and their families
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HR20279 | OTHER | MUSC | None |