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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: TAU + CBT | Experimental | The experimental group will receive treatment as usual (TAU) plus cognitive behavioral therapy (CBT). |
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| Arm 2: TAU | No Intervention | The "no intervention" group will receive treatment as usual (TAU). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy for PTSD | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica L Hamblen, PhD | White River Junction VA Medical Center, White River Junction, VT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida | 33612 | United States | ||
| Syracuse VA Medical Center, Syracuse, NY |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Behavioral Therapy (CBT) + Treatment as Usual (TAU) | 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. |
| FG001 | Treatment as Usual (TAU) | The "no intervention" group will receive treatment as usual (TAU). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Deviation | score on scale | Conclusion of treatment (post-treatment occurs approximately 4-months after treatment conclusion) and 6 months follow-up |
|
Participants were monitored for both adverse events and serious adverse events (AE/SAE) once they were enrolled in the clinical trial. Assessors and clinical staff asked participants about any possible AE/SAE at post-assessment and 6-months. CBT+TAU clinical staff also asked participants about any AE/SAEs during their clinical sessions.
Serious Adverse Events (SAEs) and Adverse Events (AEs) follow the definitions as outlined by clinicaltrials.gov but also VHA Handbook 1200.5:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Behavioral Therapy (CBT) + Treatment as Usual (TAU) | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mental Health Episode resulting in hospital encounter | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mental Health and/or Substance Abuse ER visit | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica L. Hamblen, PhD | VA National Center for PTSD | 8022965132 | jessica.hamblen@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2018 | Oct 31, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months |
| 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 |
| 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 |
| 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 |
| Syracuse |
| New York |
| 13210 |
| United States |
| White River Junction VA Medical Center, White River Junction, VT | White River Junction | Vermont | 05009-0001 | United States |
| look at data in database? |
|
| BG001 | Treatment as Usual | The "no intervention" group will receive treatment as usual (TAU) without additional individual treatment.. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | As previously indicated, all participants were recruited three VAMCs in the United States: Syracuse, NY; White River Junction, VT; and Tampa, FL. | Count of Participants | Participants |
|
| 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. |
| OG001 | Treatment as Usual | The "no intervention" group will receive treatment as usual (TAU) without additional treatment. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on scale | 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. | Posted | Mean | Standard Deviation | score on scale | 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. | Posted | Mean | Standard Deviation | score on scale | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-Treatment (approximately 4-months post treatment completion), 6 months |
|
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|
|
| 0 |
| 64 |
| 11 |
| 64 |
| 21 |
| 64 |
| EG001 | Treatment as Usual (TAU) | The "no intervention" group will receive treatment as usual (TAU). | 1 | 65 | 13 | 65 | 21 | 65 |
| Hospitalization for kidney failure | Renal and urinary disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Hospitalization due to hip replacement surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| incarceration | Social circumstances | Systematic Assessment |
|
| inpatient stay for untreated COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Testicular and groin surgery resulting in inpatient hospital stay | Renal and urinary disorders | Systematic Assessment |
|
| hospitalization due to syncopal episode | Nervous system disorders | Systematic Assessment |
|
| Jail | Social circumstances | Systematic Assessment |
|
| corneal abrasion | Eye disorders | Systematic Assessment |
|
| ER visit due to dental pain and/or possible dental abscess | General disorders | Systematic Assessment |
|
| chronic pain | General disorders | Systematic Assessment |
|
| musculature pain and discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| chest pain | Cardiac disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| low back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| kidney stones | Renal and urinary disorders | Systematic Assessment |
|
| headache | General disorders | Systematic Assessment |
|
| hemophilia | Blood and lymphatic system disorders | Systematic Assessment |
|
| testicular pain | General disorders | Systematic Assessment |
|
| motor vehicle accident which results in paralysis | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| Alcohol 6-Months |
|
| Mixed Models Analysis |
Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score. |
| .84 |
6-month P-Value. |
| Other |
| Mixed Models Analysis | Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score. | .26 | treatment main effect | Other |
| Mixed Models Analysis | Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score. | .14 | Timepoint main effect P-value | Other |
| Mixed Models Analysis | Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score. | .29 | interaction | Other |
| Mixed Models Analysis | Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score. | .16 | Site main effect P-Value. | Other |
| Drug Use 6-Months |
|
Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score. |
| .53 |
6-month P-Value. |
| Other |
| Mixed Models Analysis | Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score. | .86 | Treatment main effect P-Value. | Other |
| Mixed Models Analysis | Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score. | .16 | Timepoint main effect P-Value. | Other |
| Mixed Models Analysis | Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score. | .47 | Interaction P-Value. | Other |
| Mixed Models Analysis | Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score. | .19 | Site main effect P-Value. | Other |
| PCL 6-months |
|
Mixed model p-values are adjusted for study site and baseline PCL score. |
| .45 |
P-value at 6 months. |
| Other |
| Mixed Models Analysis | Mixed model p-values are adjusted for study site and baseline PCL score. | .73 | Treatment main effect P-Value. | Other |
| Mixed Models Analysis | Mixed model p-values are adjusted for study site and baseline PCL score. | .63 | Timepoint main effect P-Value | Other |
| Mixed Models Analysis | Mixed model p-values are adjusted for study site and baseline PCL score. | .024 | Interaction P-Value. | Other |
| Mixed Models Analysis | Mixed model p-values are adjusted for study site and baseline PCL score. | .15 | Site main effect P-Value. | Other |
| PHQ-9 6-months |
|
Mixed model p-values are adjusted for study site and baseline PHQ score. |
| .20 |
6-Month P-Value. |
| Other |
| Mixed Models Analysis | Mixed model p-values are adjusted for study site and baseline PHQ score. | .26 | Treatment main effect P-Value. | Other |
| Mixed Models Analysis | Mixed model p-values are adjusted for study site and baseline PHQ score. | .71 | Timepoint main effect. | Other |
| Mixed Models Analysis | Mixed model p-values are adjusted for study site and baseline PHQ score. | .56 | Interaction main effect P-Value. | Other |
| Mixed Models Analysis | Mixed model p-values are adjusted for study site and baseline PHQ score. | .51 | Site main effect P-Value. | Other |