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Cognitive Behavioral Therapy (CBT) for PTSD in Veterans With Co-Occurring SUDs

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01357577
First received: May 18, 2011
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

With this research, we hope to learn if cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD) works in people who have both PTSD and problems with drugs or alcohol. In the past, people who had problems with drugs and alcohol were not given treatment for their PTSD. It was believed that PTSD treatment would get in the way of their drug and alcohol treatment. Now we believe that the PTSD symptoms may make it harder to avoid using drugs and alcohol, so we want to see if people can get treatment for both problems at the same time.

One hundred-sixty Veterans from 3 VA sites will be in this study. All Veterans will be getting outpatient substance abuse treatment. In order to know if the PTSD treatment is helpful, half of the Veterans in this study will receive PTSD treatment and half will continue to get their usual substance abuse treatment. Who gets which treatment will be decided by a random process. We will then compare the 2 groups to see if there are differences in their PTSD symptoms.


Condition Intervention Phase
PTSD
Substance Use Disorders
Behavioral: Cognitive behavioral therapy for PTSD
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CBT for PTSD in Veterans With Co-Occurring Substance Use Disorders

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • PTSD symptom severity [ Time Frame: Conclusion of treatment and 6 months follow-up ] [ Designated as safety issue: No ]
    PTSD symptom severity will be measured by the Clinician Administered PTSD Scale (CAPS).


Estimated Enrollment: 160
Study Start Date: October 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT).
Behavioral: Cognitive behavioral therapy for PTSD
The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.
No Intervention: Arm 2
The "no intervention" group will receive treatment as usual (TAU).

Detailed Description:

A randomized clinical trial to evaluate the effectiveness of a relatively simple, manual-guided cognitive behavioral therapy (CBT) for PTSD in patients with substance use disorders (SUDs). One hundred sixty outpatients with comorbid PTSD and SUDs from three VA outpatient addiction treatment settings will be randomly assigned to receive either CBT for PTSD in conjunction with standard treatment as usual (TAU) (n = 80) or TAU only (n = 80) without additional individual treatment. All treatments will be delivered in the addiction setting by clinicians working in these programs.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least age 18.
  • Current SUD diagnosis.
  • Score of at least 45 on CAPS.
  • Must speak English.
  • Must agree to be taped.

Exclusion Criteria:

  • Acute psychotic symptoms, if not well connected with appropriate mental health services.
  • Severe suicidality.
  • Individuals with unstable medical or legal situations that would make completion of the study highly unlikely.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357577

Contacts
Contact: Jessica L Hamblen, PhD (802) 296-1532 jessica.hamblen@va.gov
Contact: Jessica E Hoyt, MPH BA BA (802) 291-6218 Jessica.Hoyt2@va.gov

Locations
United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL Recruiting
Tampa, Florida, United States, 33612
Contact: Rebecca Schwartzberg, PhD    813-972-2000    rebecca.schwartzberg@va.gov   
United States, New York
Syracuse VA Medical Center, Syracuse, NY Recruiting
Syracuse, New York, United States, 13210
Contact: Kyle Possemato, PhD    315-425-4400 ext 53551    kyle.possemato@va.gov   
United States, Vermont
White River Junction VA Medical Center and Regional Office, White River Junction, VT Recruiting
White River Junction, Vermont, United States, 05009-0001
Contact: Jessica L Hamblen, PhD    802-296-1532    jessica.hamblen@va.gov   
Contact: Jessica E Hoyt, MPH BA BA    (802) 291-6218    Jessica.Hoyt2@va.gov   
Principal Investigator: Jessica L Hamblen, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Jessica L Hamblen, PhD White River Junction VA Medical Center and Regional Office, White River Junction, VT
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01357577     History of Changes
Other Study ID Numbers: SPLA-01-S09
Study First Received: May 18, 2011
Last Updated: June 17, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
PTSD
Substance Use Disorders

Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014