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

Primary Purpose

PTSD, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy for PTSD
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • James A. Haley Veterans' Hospital, Tampa, FL
  • Syracuse VA Medical Center, Syracuse, NY
  • White River Junction VA Medical Center, White River Junction, VT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1: TAU + CBT

Arm 2: TAU

Arm Description

The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT).

The "no intervention" group will receive treatment as usual (TAU).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 18, 2011
Last Updated
January 17, 2020
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01357577
Brief Title
Cognitive Behavioral Therapy (CBT) for PTSD in Veterans With Co-Occurring SUDs
Acronym
CBT
Official Title
CBT for PTSD in Veterans With Co-Occurring Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Substance Use Disorders
Keywords
PTSD, Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: TAU + CBT
Arm Type
Experimental
Arm Description
The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT).
Arm Title
Arm 2: TAU
Arm Type
No Intervention
Arm Description
The "no intervention" group will receive treatment as usual (TAU).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for PTSD
Intervention Description
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.
Primary Outcome Measure Information:
Title
CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment.
Description
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.
Time Frame
Conclusion of treatment (post-treatment occurs approximately 4-months after treatment conclusion) and 6 months follow-up
Secondary Outcome Measure Information:
Title
Addiction Severity Index (Alcohol Addiction)
Description
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.
Time Frame
Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months
Title
Addiction Severity Index (Drug Use)
Description
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.
Time Frame
Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months
Title
PTSD Checklist (PCL)
Description
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.
Time Frame
Baseline, Post-Treatment (approximately 4-months post treatment completion), 6-months
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
Baseline, Post-Treatment (approximately 4-months post treatment completion), 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica L Hamblen, PhD
Organizational Affiliation
White River Junction VA Medical Center, White River Junction, VT
Official's Role
Principal Investigator
Facility Information:
Facility Name
James A. Haley Veterans' Hospital, Tampa, FL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Syracuse VA Medical Center, Syracuse, NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
White River Junction VA Medical Center, White River Junction, VT
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009-0001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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