PTSD, Substance Use Disorders
Conditions
Keywords
PTSD, Substance Use Disorders
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).
Interventions
BEHAVIORALCognitive 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment. | Conclusion of treatment (post-treatment occurs approximately 4-months after treatment conclusion) and 6 months follow-up | 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
| Measure | Time frame | Description |
|---|---|---|
| Addiction Severity Index (Alcohol Addiction) | Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months | 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) | Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months | 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) | Baseline, Post-Treatment (approximately 4-months post treatment completion), 6-months | 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) | Baseline, Post-Treatment (approximately 4-months post treatment completion), 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from three Veteran Affairs Medical Centers (VAMC): Syracuse, NY VAMC; Tampa Bay, FL VAMC; and White River Junction, VT VAMC. Participants were recruited from outpatient and inpatient clinics at the three respective facilities.
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Behavioral Therapy + Treatment as Usual The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT).
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. | 64 |
| Treatment as Usual The no intervention group will receive treatment as usual (TAU) without additional individual treatment.. | 65 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | look at data in database? | 1 | 2 |
| Overall Study | Lost to Follow-up | 20 | 16 |
| Overall Study | Withdrawal by Subject | 16 | 8 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Therapy + Treatment as Usual | Treatment as Usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 65 Participants | 129 Participants |
| Age, Continuous Age (years) | 42.2 years STANDARD_DEVIATION 12.5 | 45.9 years STANDARD_DEVIATION 11.5 | 44.2 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 7 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 58 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 19 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) White | 46 Participants | 42 Participants | 88 Participants |
| Region of Enrollment United States | 64 Participants | 65 Participants | 129 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 61 Participants | 61 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 1 / 65 |
| other Total, other adverse events | 21 / 64 | 21 / 65 |
| serious Total, serious adverse events | 11 / 64 | 13 / 65 |
Outcome results
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.
Time frame: Conclusion of treatment (post-treatment occurs approximately 4-months after treatment conclusion) and 6 months follow-up
Population: Our intention-to-treat analysis has N=80 patients (33 CBT; 47 control): It consists of patients with at least one follow-up (post or 6-mo) assessment (e.g., of the 64 participants randomized to CBT, 24 and 27 had a CAPS assessment at post and 6 months, respectively, with 33 participants having at least one valid follow-up CAPS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Therapy + Treatment as Usual | CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment. | CAPS Total Baseline | 77.2 score on scale | Standard Deviation 18.4 |
| Cognitive Behavioral Therapy + Treatment as Usual | CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment. | CAPS Total Post-Treatment | 67.5 score on scale | Standard Deviation 26.3 |
| Cognitive Behavioral Therapy + Treatment as Usual | CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment. | CAPS Total 6 Months | 72.2 score on scale | Standard Deviation 21.6 |
| Treatment as Usual | CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment. | CAPS Total Baseline | 78.0 score on scale | Standard Deviation 16.2 |
| Treatment as Usual | CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment. | CAPS Total Post-Treatment | 71.0 score on scale | Standard Deviation 26.4 |
| Treatment as Usual | CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment. | CAPS Total 6 Months | 62.9 score on scale | Standard Deviation 21.9 |
p-value: 0.072Mixed Models Analysis
p-value: 0.005Mixed Models Analysis
p-value: 0.12Mixed Models Analysis
p-value: 0.48Mixed Models Analysis
p-value: 0.12Mixed Models Analysis
p-value: 0.65Mixed Models Analysis
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.
Time frame: Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Therapy + Treatment as Usual | Addiction Severity Index (Alcohol Addiction) | Alcohol Baseline | .25 score on scale | Standard Deviation 0.22 |
| Cognitive Behavioral Therapy + Treatment as Usual | Addiction Severity Index (Alcohol Addiction) | Alcohol Post-Treatment | .13 score on scale | Standard Deviation 0.17 |
| Cognitive Behavioral Therapy + Treatment as Usual | Addiction Severity Index (Alcohol Addiction) | Alcohol 6-Months | .18 score on scale | Standard Deviation 0.18 |
| Treatment as Usual | Addiction Severity Index (Alcohol Addiction) | Alcohol Baseline | .25 score on scale | Standard Deviation 0.25 |
| Treatment as Usual | Addiction Severity Index (Alcohol Addiction) | Alcohol Post-Treatment | .17 score on scale | Standard Deviation 0.22 |
| Treatment as Usual | Addiction Severity Index (Alcohol Addiction) | Alcohol 6-Months | .20 score on scale | Standard Deviation 0.27 |
p-value: 0.84Mixed Models Analysis
p-value: 0.26Mixed Models Analysis
p-value: 0.14Mixed Models Analysis
p-value: 0.12Mixed Models Analysis
p-value: 0.29Mixed Models Analysis
p-value: 0.16Mixed Models Analysis
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.
Time frame: Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Therapy + Treatment as Usual | Addiction Severity Index (Drug Use) | Drug Use Baseline | .17 score on scale | Standard Deviation 0.18 |
| Cognitive Behavioral Therapy + Treatment as Usual | Addiction Severity Index (Drug Use) | Drug Use Post-Treatment | .09 score on scale | Standard Deviation 0.18 |
| Cognitive Behavioral Therapy + Treatment as Usual | Addiction Severity Index (Drug Use) | Drug Use 6-Months | .11 score on scale | Standard Deviation 0.15 |
| Treatment as Usual | Addiction Severity Index (Drug Use) | Drug Use Baseline | .10 score on scale | Standard Deviation 0.11 |
| Treatment as Usual | Addiction Severity Index (Drug Use) | Drug Use Post-Treatment | .08 score on scale | Standard Deviation 0.13 |
| Treatment as Usual | Addiction Severity Index (Drug Use) | Drug Use 6-Months | .04 score on scale | Standard Deviation 0.08 |
p-value: 0.66Mixed Models Analysis
p-value: 0.53Mixed Models Analysis
p-value: 0.86Mixed Models Analysis
p-value: 0.16Mixed Models Analysis
p-value: 0.47Mixed Models Analysis
p-value: 0.19Mixed Models Analysis
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.
Time frame: Baseline, Post-Treatment (approximately 4-months post treatment completion), 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Therapy + Treatment as Usual | Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 Baseline | 16.0 score on a scale | Standard Deviation 4.7 |
| Cognitive Behavioral Therapy + Treatment as Usual | Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 Post-Treatment | 15.0 score on a scale | Standard Deviation 7.4 |
| Cognitive Behavioral Therapy + Treatment as Usual | Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 6-months | 15.8 score on a scale | Standard Deviation 17.1 |
| Treatment as Usual | Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 Baseline | 14.8 score on a scale | Standard Deviation 6.8 |
| Treatment as Usual | Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 Post-Treatment | 12.8 score on a scale | Standard Deviation 7.2 |
| Treatment as Usual | Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 6-months | 12.2 score on a scale | Standard Deviation 7.4 |
p-value: 0.48Mixed Models Analysis
p-value: 0.2Mixed Models Analysis
p-value: 0.26Mixed Models Analysis
p-value: 0.71Mixed Models Analysis
p-value: 0.56Mixed Models Analysis
p-value: 0.51Mixed Models Analysis
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.
Time frame: Baseline, Post-Treatment (approximately 4-months post treatment completion), 6-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Behavioral Therapy + Treatment as Usual | PTSD Checklist (PCL) | PCL Baseline | 62.7 score on scale | Standard Deviation 9.2 |
| Cognitive Behavioral Therapy + Treatment as Usual | PTSD Checklist (PCL) | PCL Post-Treatment | 54.3 score on scale | Standard Deviation 17.7 |
| Cognitive Behavioral Therapy + Treatment as Usual | PTSD Checklist (PCL) | PCL 6-months | 56.7 score on scale | Standard Deviation 13.7 |
| Treatment as Usual | PTSD Checklist (PCL) | PCL Baseline | 62.1 score on scale | Standard Deviation 13.3 |
| Treatment as Usual | PTSD Checklist (PCL) | PCL Post-Treatment | 56.9 score on scale | Standard Deviation 15.7 |
| Treatment as Usual | PTSD Checklist (PCL) | PCL 6-months | 54.2 score on scale | Standard Deviation 16.9 |
p-value: 0.18Mixed Models Analysis
p-value: 0.45Mixed Models Analysis
p-value: 0.73Mixed Models Analysis
p-value: 0.63Mixed Models Analysis
p-value: 0.024Mixed Models Analysis
p-value: 0.15Mixed Models Analysis