Post-Traumatic Stress Symptoms, Problematic Use of Alcohol or Other Drugs
Conditions
Keywords
Web-based CBT, PTSD, Alcohol Misuse, Substance Misuse, Integrated Primary Care, OEF/OIF Veterans
Brief summary
The proposed study involves developing and evaluating an interactive, web-based CBT intervention for OEF/OIF Veterans with hazardous or problematic substance use and PTSD symptoms (PTSD or subsyndromal PTSD). The intervention will address the special culture and experiences of the investigators targeted population (OEF/OIF Veterans). The web-based CBT intervention includes 24 modules, to be used across 24 sessions targeting OEF/OIF Veterans with hazardous or problematic substance use and PTSD symptoms. The investigators ask participants to complete 2 sessions per week (one module per session) for 12 weeks. The first 18 modules to be completed across 18 sessions (9 weeks) are considered core modules relevant to all Veterans in the target population. These modules are designed to reduce posttraumatic stress symptoms as well as reduce and prevent the escalation of problematic substance use. The remaining 6 module topics are considered optional and are used based on the interest and clinical need of various sub-groups of VA patients. The study includes initial input as well as feedback on a beta version from experts who have worked with OEF/OIF veterans with PTSD and substance abuse problems as well as input/feedback from the target population (the Veterans themselves). In addition to presenting content grounded in evidence-based CBT interventions, the program also employs state of the art technologies to deliver module content grounded in evidence-based learning principles, including Computer-Assisted Instruction, Computer Simulation and other interactive exercises.
Interventions
BEHAVIORALWeb-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.
Sponsors
The VA Western New York Healthcare System
Syracuse VA Medical Center
National Development and Research Institutes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase 1: Focus Groups Inclusion Criteria: 1. At least 18 years of age 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)
Exclusion criteria
1. Insufficient ability to understand or provide informed consent 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 Inclusion Criteria 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptomatology | 12 weeks | Comparing baseline score of the PCL-M to 12 weeks score |
| Alcohol and Drug Use | 12 weeks | Comparing baseline score of the Timeline Follow-back (TLFB)to 12 weeks score |
| Quality of Life | 12 weeks | Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 12 weeks |
| Cost-Effectiveness | 12 weeks | Cost-effectiveness of web-based intervention compared to standard care, as measured by the Brief DATCAP, EuroQol EQ5D, and Non-Study Medical and Other Services (NSMS) scales |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resiliency and Positive Affect | 12 weeks | Comparing baseline Connor-Davidson Resilience Scale (CD-RISC) and the Positive Affect Negative Affect Scale (PANAS)scores to scores at 12 weeks |
| Treatment Satisfaction | 12 weeks | As measured using visual analog scales assessing participant's impressions of how useful, interesting, etc. their treatment has been. |
| Insomnia | 12 weeks | Comparing baseline Insomnia Severity Index (ISI)score to score at 12 weeks |
| Psychological Distress | 12 weeks | Comparing baseline score on the 10-item version of Symptom Checklist-90 (SCL-90) to score at 12 weeks |
| Pain Severity and Pain Interference | 12 weeks | Comparing baseline score on the Brief Pain Inventory (BPI) to score at 12 weeks |
Countries
United States
Contacts
Primary ContactKyle Possemato, Ph.D.
Backup ContactMichelle Acosta, Ph.D.
Outcome results
None listed