Post-Traumatic Stress SymptomsPhase 1/2Web CBTNCT01710943
Web-based CBT for Recent Veterans Experiencing Problems With Trauma Symptoms or Alcohol/Drug Use
A Phase 1/2 study testing Web-based Cognitive Behavioral Treatment in people with Post-Traumatic Stress Symptoms and Problematic Use of Alcohol or Other Drugs, run by National Development and Research Institutes, Inc. at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Symptoms, Problematic Use of Alcohol or Other Drugs
- What is being tested?
- Web-based Cognitive Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Jun 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- At least 18 years of age
- An OEF or OIF veteran (verified via CPRS)
Show all 22Show fewer
- 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:
- 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)
- 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 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:
- 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)
- 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).
- Currently receiving primary medical care at a VA Medical Center (verified via CPRS)
Who cannot join
- 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
- 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.
Show all 16Show fewer
- 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
- Plans to move out of area within the next three months
- Currently enrolled in a substance abuse treatment program or receiving treatment for PTSD from a mental health professional (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.
- In need of alcohol detoxification as determined by a score of > 15 on the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar).
- Current plan or intent to harm themselves as measured with the suicide assessment in Appendix D administered after the consent process.
- Medical chart diagnosis of a current psychotic disorder, including schizophrenia or bi-polar disorder
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Buffalo VA Medical Center
Buffalo, New York, 14215
Larry Lantinga, Ph.D.
- Recruiting
Syracuse VA Medical Center
Syracuse, New York, 13210
Kyle Possemato, Ph.D.
About this study
Official title: Web-based CBT for Substance Misusing and PTSD Symptomatic OEF/OIF Veterans
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.
- Being tested
- Web-based Cognitive Behavioral Treatment
- Keywords
- Web-based CBT, PTSD, Alcohol Misuse, Substance Misuse, Integrated Primary Care, OEF/OIF Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Cognitive Behavioral TreatmentBehavioural
Also called Web-based CBT
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-based Cognitive Behavioral Treatment | Experimental | 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. Receives: Behavioral: Web-based Cognitive Behavioral Treatment |
| Treatment as Usual | No intervention | 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 . |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptomatology
Comparing baseline score of the PCL-M to 12 weeks score
Measured: 12 weeks
PTSD Symptomatology
Comparing baseline score of the PCL-M to score 1 month post-intervention discharge
Measured: 1 month post-intervention
PTSD Symptomatology
Comparing baseline score of the PCL-M to score 3 months post-intervention
Measured: 3 months post-intervention
Alcohol and Drug Use
Comparing baseline score of the Timeline Follow-back (TLFB)to 12 weeks score
Measured: 12 weeks
Alcohol and Drug Use
Comparing baseline TLFB score to score 1 month post-intervention
Measured: 1 month post-intervention
Alcohol and Drug Use
Comparing baseline TLFB score to score 3 month post-intervention
Measured: 3 month post-intervention
Quality of Life
Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 12 weeks
Measured: 12 weeks
Quality of Life
Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 1 month post-intervention
Measured: 1 month post-intervention
Quality of Life
Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 3 months post-intervention
Measured: 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
Measured: 12 weeks
Secondary outcomes (13)
Resiliency and Positive Affect
Comparing baseline Connor-Davidson Resilience Scale (CD-RISC) and the Positive Affect Negative Affect Scale (PANAS)scores to scores at 12 weeks
Measured: 12 weeks
Resiliency and Positive Affect
Comparing baseline Connor-Davidson Resilience Scale (CD-RISC) and the Positive Affect Negative Affect Scale (PANAS)scores to scores at 1 month post-intervention
Measured: 1 month post-intervention
Resiliency and Positive Affect
Comparing baseline Connor-Davidson Resilience Scale (CD-RISC) and the Positive Affect Negative Affect Scale (PANAS)scores to scores at 3 months post-intervention
Measured: 3 months post-intervention
Insomnia
Comparing baseline Insomnia Severity Index (ISI)score to score at 12 weeks
Measured: 12 weeks
Insomnia
Comparing baseline score on the Insomnia Severity Index (ISI) to score at 1 month post-intervention
Measured: 1 month post-intervention
Insomnia
Comparing baseline score on the Insomnia Severity Index (ISI) to score at 3 month post-intervention
Measured: 3 months post-intervention
Psychological Distress
Comparing baseline score on the 10-item version of Symptom Checklist-90 (SCL-90) to score at 12 weeks
Measured: 12 weeks
Psychological Distress
Comparing baseline score on the 10-item version of Symptom Checklist-90 (SCL-90) to score at 1 month post-intervention
Measured: 1 month post-intervention
Psychological Distress
Comparing baseline score on the 10-item version of Symptom Checklist-90 (SCL-90) to score at 3 months post-intervention
Measured: 3 months post-intervention
Pain Severity and Pain Interference
Comparing baseline score on the Brief Pain Inventory (BPI) to score at 12 weeks
Measured: 12 weeks
Pain Severity and Pain Interference
Comparing baseline score on the Brief Pain Inventory (BPI) to score at 1 month post-intervention
Measured: 1 month post-intervention
Pain Severity and Pain Interference
Comparing baseline score on the Brief Pain Inventory (BPI) to score at 3 months post-intervention
Measured: 3 months post-intervention
Treatment Satisfaction
As measured using visual analog scales assessing participant's impressions of how useful, interesting, etc. their treatment has been.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startSep 2010
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- The VA Western New York Healthcare System, Syracuse VA Medical Center
- Responsible party
- Principal investigator, Andrew Rosenblum, National Development and Research Institutes, Inc.
- Investigators
- Andrew Rosenblum, Ph.D., Principal investigator, National Development and Research Institutes, Inc.Stephen Maisto, Ph.D., Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710943
- Sponsor's protocol ID
- R01AA020181
- Acronym
- Web CBT
- Status last verified
- Oct 2012
- First submitted
- 26 Apr 2012
- Last updated
- 19 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based CBT for Substance Misusing and PTSD Symptomatic OEF/OIF Veterans
- ClinicalTrials.gov ID
- NCT01710943
- Acronym / sponsor ID
- Web CBT / R01AA020181
- Keywords
- Web-based CBT, PTSD, Alcohol Misuse, Substance Misuse, Integrated Primary Care, OEF/OIF Veterans
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- The VA Western New York Healthcare System, Syracuse VA Medical Center
- Study start
- Sep 2010
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based Cognitive Behavioral Treatment | Experimental | Behavioral: Web-based Cognitive Behavioral TreatmentParticipants 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 intervention | –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 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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)
- At least 18 years of age
Key exclusion criteria (16 listed)
- 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
- Insufficient ability to understand or provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based Cognitive Behavioral TreatmentAlso: Web-based CBTParticipants 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. | Behavioural | Web-based Cognitive Behavioral Treatment |
Primary outcome
PTSD Symptomatology
Time frame: 12 weeks
Comparing baseline score of the PCL-M to 12 weeks score
PTSD Symptomatology
Time frame: 1 month post-intervention
Comparing baseline score of the PCL-M to score 1 month post-intervention discharge
PTSD Symptomatology
Time frame: 3 months post-intervention
Comparing baseline score of the PCL-M to score 3 months post-intervention
Alcohol and Drug Use
Time frame: 12 weeks
Comparing baseline score of the Timeline Follow-back (TLFB)to 12 weeks score
Alcohol and Drug Use
Time frame: 1 month post-intervention
Comparing baseline TLFB score to score 1 month post-intervention
Alcohol and Drug Use
Time frame: 3 month post-intervention
Comparing baseline TLFB score to score 3 month post-intervention
Quality of Life
Time frame: 12 weeks
Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 12 weeks
Quality of Life
Time frame: 1 month post-intervention
Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 1 month post-intervention
Quality of Life
Time frame: 3 month post-intervention
Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 3 months post-intervention
Cost-Effectiveness
Time frame: 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
13 secondary outcomes
Resiliency and Positive Affect
Time frame: 12 weeks
Resiliency and Positive Affect
Time frame: 1 month post-intervention
Resiliency and Positive Affect
Time frame: 3 months post-intervention
Insomnia
Time frame: 12 weeks
Insomnia
Time frame: 1 month post-intervention
Insomnia
Time frame: 3 months post-intervention
Psychological Distress
Time frame: 12 weeks
Psychological Distress
Time frame: 1 month post-intervention
Psychological Distress
Time frame: 3 months post-intervention
Pain Severity and Pain Interference
Time frame: 12 weeks
Pain Severity and Pain Interference
Time frame: 1 month post-intervention
Pain Severity and Pain Interference
Time frame: 3 months post-intervention
Treatment Satisfaction
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
Related trials for Post-Traumatic Stress Symptoms
RecruitingPhase 3
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
Major Depression
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Active, not recruiting
Manage Emotions to Reduce Aggression (MERA)
Stress Disorders, Post-Traumatic, Aggression
Enrolling by invitationObservational study
Cannabis, Neuroinflammation, and Suicidal Ideation: A Supplemental Brain Imaging Study
PTSD, Suicidal Thoughts and Behaviors
Active, not recruitingPhase 3
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
Delirium, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Rosenblum, Ph.D. principal investigator
National Development and Research Institutes, Inc.
Stephen Maisto, Ph.D. principal investigator
Syracuse University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Web-based Cognitive Behavioral Treatment in people with Post-Traumatic Stress Symptoms and Problematic Use of Alcohol or Other Drugs, run by National Development and Research Institutes, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyle Possemato, Ph.D. (315-425-4400 ext. 53551, kyle.possemato@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptomatology (time frame: 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2012.