Web-based CBT for Recent Veterans Experiencing Problems With Trauma Symptoms or Alcohol/Drug Use
Web CBT
Web-based CBT for Substance Misusing and PTSD Symptomatic OEF/OIF Veterans
1 other identifier
interventional
216
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2010
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 26, 2012
CompletedFirst Posted
Study publicly available on registry
October 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedOctober 19, 2012
October 1, 2012
3.8 years
April 26, 2012
October 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
PTSD Symptomatology
Comparing baseline score of the PCL-M to 12 weeks score
12 weeks
PTSD Symptomatology
Comparing baseline score of the PCL-M to score 1 month post-intervention discharge
1 month post-intervention
PTSD Symptomatology
Comparing baseline score of the PCL-M to score 3 months post-intervention
3 months post-intervention
Alcohol and Drug Use
Comparing baseline score of the Timeline Follow-back (TLFB)to 12 weeks score
12 weeks
Alcohol and Drug Use
Comparing baseline TLFB score to score 1 month post-intervention
1 month post-intervention
Alcohol and Drug Use
Comparing baseline TLFB score to score 3 month post-intervention
3 month post-intervention
Quality of Life
Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 12 weeks
12 weeks
Quality of Life
Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 1 month post-intervention
1 month post-intervention
Quality of Life
Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 3 months post-intervention
3 month post-intervention
Cost-Effectiveness
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
12 weeks
Secondary Outcomes (13)
Resiliency and Positive Affect
12 weeks
Resiliency and Positive Affect
1 month post-intervention
Resiliency and Positive Affect
3 months post-intervention
Insomnia
12 weeks
Insomnia
1 month post-intervention
- +8 more secondary outcomes
Study Arms (2)
Web-based Cognitive Behavioral Treatment
EXPERIMENTALParticipants 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.
Treatment as Usual
NO INTERVENTIONTAU 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 .
Interventions
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.
Eligibility Criteria
You may qualify if:
- At least 18 years of age
- An OEF or OIF veteran (verified via CPRS)
- Screen positive on the Audit-C (\>=3 for women or \>= 4 for men) OR screen positive on the PC-PTSD (\>=3).
- Currently receiving primary medical care at a VA Medical Center (verified via CPRS)
You may not qualify if:
- Insufficient ability to understand or provide informed consent
- Lack sufficient ability to use English to participate in the consent process,
- Current plan or intent to harm themselves as measured with the suicide assessment in Appendix D after the consent process.
- Phase 2: Feedback Sessions
- At least 18 years of age
- An OEF or OIF veteran (verified via CPRS)
- 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)
- Screen positive on the PC-PTSD (\>=2).
- Currently receiving primary medical care at a VA Medical Center (verified via CPRS)
- Insufficient ability to understand or provide informed consent
- Lack sufficient ability to use English to participate in the consent process, the computerized intervention or the assessments.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Buffalo VA Medical Center
Buffalo, New York, 14215, United States
Syracuse VA Medical Center
Syracuse, New York, 13210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Rosenblum, Ph.D.
National Development and Research Institutes, Inc.
- PRINCIPAL INVESTIGATOR
Stephen Maisto, Ph.D.
Syracuse University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Institute for Treatment and Services Research
Study Record Dates
First Submitted
April 26, 2012
First Posted
October 19, 2012
Study Start
September 1, 2010
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
October 19, 2012
Record last verified: 2012-10