Web-based CBT for Recent Veterans Experiencing Problems With Trauma Symptoms or Alcohol/Drug Use
NCT ID: NCT01710943
Last Updated: 2012-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
216 participants
INTERVENTIONAL
2010-09-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Web-based Cognitive Behavioral Treatment
Participants who are randomly assigned to the treatment condition will receive the same standard care as those in the control condition and they will also receive access to the web-based CBT intervention. Participants in this condition will be asked to complete 24 CBT sessions, 2 sessions/topics per week for 12 weeks. Participants will be asked to complete the 18 "core modules" of the program during the first 9 weeks of the trial and then to re-visit important modules and complete optional modules of their choice during the final 3 weeks of the trial.
Web-based Cognitive Behavioral Treatment
Participants in this condition will be asked to complete 24 CBT sessions, 2 sessions/topics per week for 12 weeks. We expect that each session will be approximately 30 minutes in duration. Participants will be asked to complete the 18 "core modules" of the program during the first 9 weeks of the trial and then to re-visit important modules and complete optional modules of their choice during the final 3 weeks of the trial. They can choose to do this using a designated computer in a private room at their local VA or can complete these sessions in the privacy of their own home with their personally-owned computers. Participants can choose to complete each session on any day/time of their choosing in a given week.
Treatment as Usual
TAU consists of the usual Veterans Integrated Service Network 2 (VISN) primary care services. As we have described, all of the participants will be recruited from patients presenting for treatment typically for physical complaints in primary care clinics in VA's VISN 2 (Upstate NY). VISN 2 officially practices a co-located, collaborative care model of integrated (behavioral health and physical health) in its primary care clinics. This integrated model has been implemented widely in both VA and non-VA primary care clinics in the United States .
No interventions assigned to this group
Interventions
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Web-based Cognitive Behavioral Treatment
Participants in this condition will be asked to complete 24 CBT sessions, 2 sessions/topics per week for 12 weeks. We expect that each session will be approximately 30 minutes in duration. Participants will be asked to complete the 18 "core modules" of the program during the first 9 weeks of the trial and then to re-visit important modules and complete optional modules of their choice during the final 3 weeks of the trial. They can choose to do this using a designated computer in a private room at their local VA or can complete these sessions in the privacy of their own home with their personally-owned computers. Participants can choose to complete each session on any day/time of their choosing in a given week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. An OEF or OIF veteran (verified via CPRS)
3. Screen positive on the Audit-C (\>=3 for women or \>= 4 for men) OR screen positive on the PC-PTSD (\>=3).
4. Currently receiving primary medical care at a VA Medical Center (verified via CPRS)
1. At least 18 years of age
2. An OEF or OIF veteran (verified via CPRS)
3. Hazardous or harmful substance use as measured by one of the following:
* AUDIT-C score of \>=3 (for women) or \>= 4 (for men) OR
* DAST score of \>=2 OR
* Have exited a controlled environment (e.g., detoxification unit, hospital, or correctional facility) within 30 days of screening AND within 30 days prior to entering the controlled environment report:
i. heavy drinking (\>3 drinks for women or \> 4 drinks for men on one or more days), or ii.use of any illegal drugs, iii.or misuse of prescription drugs (use in excess of the directions or any non-medical use)
4. Screen positive on the PC-PTSD (\>=2).
5. Currently receiving primary medical care at a VA Medical Center (verified via CPRS)
1. At least 18 years of age
2. An OEF or OIF veteran (verified via CPRS)
3. Hazardous or harmful substance use as measured by one of the following:
* AUDIT score of \>=7 (for women) or \>= 8 (for men) OR
* DAST score of \>=2 OR
* Have exited a controlled environment (e.g., detoxification unit, hospital, or correctional facility) within 30 days of screening AND within 30 days prior to entering the controlled environment report:
i. heavy drinking (\>3 drinks for women or \> 4 drinks for men on1 or more days) or ii. use of any illegal drugs iii. misuse of prescription drugs (use in excess of the directions or any non-medical use)
4. Determined to have diagnostic-level or PTSD (1 A symptom, 1 B symptom, 3 C symptoms AND 2 D symptoms) or subthreshold PTSD (1 A symptom, 1 B symptom, 3 C symptoms OR 2 D symptoms) on the Clinician Administered PTSD Scale (CAPS).
5. Currently receiving primary medical care at a VA Medical Center (verified via CPRS)
Exclusion Criteria
2. Lack sufficient ability to use English to participate in the consent process,
3. Current plan or intent to harm themselves as measured with the suicide assessment in Appendix D after the consent process.
Phase 2: Feedback Sessions
1. Insufficient ability to understand or provide informed consent
2. Lack sufficient ability to use English to participate in the consent process, the computerized intervention or the assessments.
3. Current plan or intent to harm themselves as measured with the suicide assessment in Appendix D administered after the consent process.
Phase 3: Randomized Clinical Trial
1. Plans to move out of area within the next three months
2. Currently enrolled in a substance abuse treatment program or receiving treatment for PTSD from a mental health professional (verified via CPRS).
3. Insufficient ability to understand or provide informed consent
4. Lack sufficient ability to use English to participate in the consent process, the computerized intervention or the assessments.
5. In need of alcohol detoxification as determined by a score of \> 15 on the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar).
6. Current plan or intent to harm themselves as measured with the suicide assessment in Appendix D administered after the consent process.
7. Medical chart diagnosis of a current psychotic disorder, including schizophrenia or bi-polar disorder
8. Cognitive impairment specified by a medical chart diagnosis. Diagnoses include dementia and moderate to severe traumatic brain injury (TBI). Patients with mild TBI will not be excluded. The Second Level TBI Assessment present in patient medical records can be used to verify the severity of TBI.
18 Years
ALL
No
Sponsors
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The VA Western New York Healthcare System
FED
Syracuse VA Medical Center
FED
National Development and Research Institutes, Inc.
OTHER
Responsible Party
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Andrew Rosenblum
Director, Institute for Treatment and Services Research
Principal Investigators
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Andrew Rosenblum, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Development and Research Institutes, Inc.
Stephen Maisto, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Syracuse University
Locations
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Buffalo VA Medical Center
Buffalo, New York, United States
Syracuse VA Medical Center
Syracuse, New York, United States
Countries
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Central Contacts
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Other Identifiers
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