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

PTSD Clinical Trial

— CBT  

Official title:

CBT for PTSD in Veterans With Co-Occurring Substance Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357577
• Other study ID #: SPLA-01-S09
• Status: Completed
• Phase: N/A
• Start date: January 1, 2013
• Est. completion date: October 31, 2017

Study information

• Verified date: January 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• PTSD
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida
United States	White River Junction VA Medical Center, White River Junction, VT	White River Junction	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment.	PTSD symptom severity will be measured by the Clinician Administered PTSD Scale (CAPS). The Clinician Administered PTSD SCALE (CAPS) is the gold standard in PTSD assessment. It is a structured interview that can be used to: Make current (past month) diagnosis of PTSD and Make lifetime diagnosis of PTSD. The minimum value is a 0 and the maximum is 135, the higher the score the worse the outcome, i.e. the more severe PTSD.	Conclusion of treatment (post-treatment occurs approximately 4-months after treatment conclusion) and 6 months follow-up
Secondary	Addiction Severity Index (Alcohol Addiction)	The ASI is a standardized, structured interview that assesses past 30 days problem severity in seven areas. These seven areas include medical, employment, drug, alcohol, legal, family/social and psychiatric status. Problem severity is rated on a scale of 0.0 - 1.0 with a higher score indicative of more problem severity. All scales have a range from 0 to 1.0.	Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months
Secondary	Addiction Severity Index (Drug Use)	The ASI is a standardized, structured interview that assesses past 30 days problem severity in seven areas. These seven areas include medical, employment, drug, alcohol, legal, family/social and psychiatric status. Problem severity is rated on a scale of 0.0 - 1.0 with a higher score indicative of more problem severity. All scales have a range from 0 to 1.0.	Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months
Secondary	PTSD Checklist (PCL)	A secondary measure of PTSD will be the PCL. The PCL is a widely used self-report measure that assesses the 17 DSM-IV PTSD symptoms. Responses to these questions are on a scale of 1 to 5 ("not at all" to "extremely"). A total symptom severity score (range from 17-85) can be calculated, with a higher score indicating higher symptom severity.	Baseline, Post-Treatment (approximately 4-months post treatment completion), 6-months
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is adapted from the PRIME-MD. It can be used as a screen for depression or as a severity measure. The investigators used it as a measure of severity. The PHQ-9 score is on a range of 0 to 27, where a higher score indicates higher severity.	Baseline, Post-Treatment (approximately 4-months post treatment completion), 6 months