Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders

NCT01338506 | Completed Results DMC

• 2 other identifiers: R01DA030143-01HR20279
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorders; Combat Disorders; Alcohol Dependence; Drug Dependence

Keywords

Military; Posttraumatic Stress Disorder; PTSD; PostTraumatic Stress Disorders; Combat; Psychological Treatment; Psychotherapy; Trauma; Posttraumatic Stress; Prolonged Exposure; Exposure therapy; Behavior Therapy; Cognitive Behavior Therapy; Stress Disorders; Drug Abuse; Drug Dependence; Alcohol Abuse; Alcohol Dependence; Substance Use Disorders; Alcoholism

Outcome Measures

Primary Outcomes (4)

• Change in Post-traumatic Stress Disorder Symptomatology

  The hypothesis is that COPE will significantly exceed the treatment as usual control group in reducing Change in Post-traumatic Stress Disorder symptoms as measured by a reduction of 25 points or more in scores for the Clinician Administered Post-traumatic Stress Disorder Scale (CAPS). A lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes. A negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes). Clinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms ≥80: extreme PTSD symptoms Post-traumatic Stress Disorder Checklist: score range 17-85.

  Following 12 weeks of therapy.

• Drinks Per Drinking Day

  Number of standard drinks reported during drinking day

  Following 12 weeks of therapy.

• Post-traumatic Stress Disorder Symptomatology

  Score of PTSD from Clinician Administered PTSD Scale (CAPS) and self-administered PTSD Checklist for DSM-5 PTSD Diagnosis (PCL-5). Lower scores on CAPS and PCL would indicate less severe PTSD. A lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes. A negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes). Clinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms ≥80: extreme PTSD symptoms Post-traumatic Stress Disorder Checklist: score range 17-85.

  Following 12 weeks of therapy.

• Clinician Administered PTSD Scale Itemized Scores

  Clinician Administered PTSD Scale Itemized Scores Within the assessment there are 20 symptoms of PTSD, each with an individual score. A lower score would represent a better outcome (ie less severe symptom). The three itemized symptoms listed below represent hallmark traits/symptoms of PTSD. Overall score range 0-136 Reexperiencing Symptoms range 0-40 Avoidance/Numbing range 0-56 Hyperarousal range 0-40

  After 12 weeks of treatment

Secondary Outcomes (2)

• Number of Participants Who Report Abstinence

  Following 12 weeks of therapy.

• Beck Depression Index

  Following 12 weeks of therapy.

Study Arms (2)

COPE Therapy

EXPERIMENTAL

Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder.

Behavioral: Concurrent Treatment with Prolonged Exposure (COPE)

Treatment as usual

ACTIVE COMPARATOR

CBT for substance use disorder.

Behavioral: Concurrent Treatment with Prolonged Exposure (COPE)

Interventions

Concurrent Treatment with Prolonged Exposure (COPE) BEHAVIORAL

12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).

Also known as: Prolonged Exposure

COPE Therapy; Treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

Related Publications (6)

• Szafranski DD, Snead A, Allan NP, Gros DF, Killeen T, Flanagan J, Pericot-Valverde I, Back SE. Integrated, exposure-based treatment for PTSD and comorbid substance use disorders: Predictors of treatment dropout. Addict Behav. 2017 Oct;73:30-35. doi: 10.1016/j.addbeh.2017.04.005. Epub 2017 Apr 4.

  PMID: 28460246 BACKGROUND

• Mills AC, Badour CL, Korte KJ, Killeen TK, Henschel AV, Back SE. Integrated Treatment of PTSD and Substance Use Disorders: Examination of Imaginal Exposure Length. J Trauma Stress. 2017 Apr;30(2):166-172. doi: 10.1002/jts.22175. Epub 2017 Mar 22.

  PMID: 28329434 BACKGROUND

• Korte KJ, Bountress KE, Tomko RL, Killeen T, Moran-Santa Maria M, Back SE. Integrated Treatment of PTSD and Substance Use Disorders: The Mediating Role of PTSD Improvement in the Reduction of Depression. J Clin Med. 2017 Jan 13;6(1):9. doi: 10.3390/jcm6010009.

  PMID: 28098747 BACKGROUND

• Lancaster CL, Gros DF, Mullarkey MC, Badour CL, Killeen TK, Brady KT, Back SE. Does trauma-focused exposure therapy exacerbate symptoms among patients with comorbid PTSD and substance use disorders? Behav Cogn Psychother. 2020 Jan;48(1):38-53. doi: 10.1017/S1352465819000304. Epub 2019 Apr 23.

  PMID: 31010449 BACKGROUND

• Back SE, Killeen T, Badour CL, Flanagan JC, Allan NP, Ana ES, Lozano B, Korte KJ, Foa EB, Brady KT. Concurrent treatment of substance use disorders and PTSD using prolonged exposure: A randomized clinical trial in military veterans. Addict Behav. 2019 Mar;90:369-377. doi: 10.1016/j.addbeh.2018.11.032. Epub 2018 Nov 27.

  PMID: 30529244 RESULT

• Badour CL, Flanagan JC, Gros DF, Killeen T, Pericot-Valverde I, Korte KJ, Allan NP, Back SE. Habituation of distress and craving during treatment as predictors of change in PTSD symptoms and substance use severity. J Consult Clin Psychol. 2017 Mar;85(3):274-281. doi: 10.1037/ccp0000180.

  PMID: 28221062 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders; Alcoholism; Substance-Related Disorders; Wounds and Injuries; Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Dr. Sudie Back
• Organization: Medical University of South Carolina

backs@musc.edu

843-792-9383

Study Officials

• Sudie E Back, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 19, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 11, 2020
• Results First Posted: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)