N/A
N=81
Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders
Posttraumatic Stress Disorders · Combat Disorders · Alcohol Dependence · Drug Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01338506 ↗Enrolled (actual)
81
Serious AEs
2.5%
Results posted
Feb 2020
Primary outcome: Primary: Change in Post-traumatic Stress Disorder Symptomatology — -51.2; -35.9; -22.3; -10.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Concurrent Treatment with Prolonged Exposure (COPE) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Post-traumatic Stress Disorder Symptomatology |
-51.2; -35.9; -22.3; -10.9 | — |
| PRIMARY Drinks Per Drinking Day |
4.6; 5.0 | — |
| PRIMARY Post-traumatic Stress Disorder Symptomatology |
27.2; 49.7; 37.6; 53.1 | — |
| PRIMARY Clinician Administered PTSD Scale Itemized Scores |
5.6; 14.6; 10.8; 24; 11.7; 19.1 | — |
| SECONDARY Number of Participants Who Report Abstinence |
7; 22 | — |
| SECONDARY Beck Depression Index |
13; 19.4 | — |
Summary
In comparison to the general population, U.S. 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 U.S. military and Veterans, with SUD/PTSD 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.
Eligibility Criteria
Inclusion Criteria
- Adult male and female active-duty OIF/OEF military personnel and separated OIF/OEF veterans ages 18-65.
- Diagnosis of PTSD determined by a clinician-administered study interview.
Exclusion Criteria
- Current bipolar disorder or other psychotic disorder (as determined by the evaluator conducting the patient interview and medical record review)
- subjects with a current eating disorder or with dissociative identity disorder
- currently in ongoing therapy for SUDs or PTSD, who are not willing to discontinue these therapies for the duration of the trial
- recently prescribed maintenance anxiolytic, antidepressant, or mood stabilizing medications (must be stabilized for four weeks on meds before entry into study)
- Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
Data sourced from ClinicalTrials.gov (NCT01338506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.