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

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ClinicalTrials.gov Identifier: NCT01357577
Recruitment Status : Active, not recruiting
First Posted : May 20, 2011
Last Update Posted : December 27, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

With this research, the investigators 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 the investigators believe that the PTSD symptoms may make it harder to avoid using drugs and alcohol, so the investigators 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. The investigators will then compare the 2 groups to see if there are differences in their PTSD symptoms.

Condition or disease Intervention/treatment
PTSD Substance Use Disorders Behavioral: Cognitive behavioral therapy for PTSD

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CBT for PTSD in Veterans With Co-Occurring Substance Use Disorders
Actual Study Start Date : January 1, 2013
Primary Completion Date : October 31, 2017
Estimated Study Completion Date : April 30, 2018
Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1: TAU + CBT
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: TAU
The "no intervention" group will receive treatment as usual (TAU).

Outcome Measures

Primary Outcome Measures :
  1. PTSD symptom severity [ Time Frame: Conclusion of treatment and 6 months follow-up ]
    PTSD symptom severity will be measured by the Clinician Administered PTSD Scale (CAPS).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357577

United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
United States, New York
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, United States, 13210
United States, Vermont
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, United States, 05009-0001
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Jessica L Hamblen, PhD White River Junction VA Medical Center, White River Junction, VT
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01357577     History of Changes
Other Study ID Numbers: SPLA-01-S09
First Posted: May 20, 2011    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Substance Use Disorders

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