Clinical trial NCT01357577: Cognitive Behavioral Therapy (CBT) for PTSD in Veterans With Co-Occurring SUDs
Official title: CBT for PTSD in Veterans With Co-Occurring Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Substance Use Disorders
Keywords: PTSD
Substance Use Disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-05-20
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 sites who have both PTSD and substance use disorders will be in the study. 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 mental health and/or 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.

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 facilities 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).

Eligibility 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.

Primary outcomes:
measure: CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment.
timeFrame: Conclusion of treatment (post-treatment occurs approximately 4-months after treatment conclusion) and 6 months follow-up
Secondary outcomes:
measure: Addiction Severity Index (Alcohol Addiction)
timeFrame: Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months
measure: Addiction Severity Index (Drug Use)
timeFrame: Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months
measure: PTSD Checklist (PCL)
timeFrame: Baseline, Post-Treatment (approximately 4-months post treatment completion), 6-months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, Post-Treatment (approximately 4-months post treatment completion), 6 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
city: White River Junction
country: United States
facility: White River Junction VA Medical Center, White River Junction, VT
state: Vermont
Study officials:
affiliation: White River Junction VA Medical Center, White River Junction, VT
name: Jessica L Hamblen, PhD
role: PRINCIPAL_INVESTIGATOR
References: