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

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 Overview

• Status: Unknown
• Conditions: Post-Traumatic Stress Symptoms; Problematic Use of Alcohol or Other Drugs
• Intervention / Treatment: Behavioral: Web-based Cognitive Behavioral Treatment

• Study Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Kyle Possemato, Ph.D.; Phone Number: 53551 315-425-4400; Email: kyle.possemato@va.gov

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215
      • Recruiting
      • Buffalo VA Medical Center
      • Principal Investigator: Larry Lantinga, Ph.D.
    • Syracuse, New York, United States, 13210
      • Recruiting
      • Syracuse VA Medical Center
      • Principal Investigator: Kyle Possemato, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Exclusion Criteria:

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

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 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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: 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 Names: Web-based CBT
NO_INTERVENTION: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	3 months post-intervention
Insomnia	Comparing baseline Insomnia Severity Index (ISI)score to score at 12 weeks	12 weeks
Insomnia	Comparing baseline score on the Insomnia Severity Index (ISI) to score at 1 month post-intervention	1 month post-intervention
Insomnia	Comparing baseline score on the Insomnia Severity Index (ISI) to score at 3 month post-intervention	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	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	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	3 months post-intervention
Pain Severity and Pain Interference	Comparing baseline score on the Brief Pain Inventory (BPI) to score at 12 weeks	12 weeks
Pain Severity and Pain Interference	Comparing baseline score on the Brief Pain Inventory (BPI) to score at 1 month post-intervention	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	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.	12 weeks

Collaborators and Investigators

• Sponsor: National Development and Research Institutes, Inc.
• Collaborators: Syracuse VA Medical Center; The VA Western New York Healthcare System
• Investigators: Principal Investigator: Stephen Maisto, Ph.D., Syracuse University

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ANTICIPATED): June 1, 2014
• Study Completion (ANTICIPATED): June 1, 2014

Study Registration Dates

• First Submitted: April 26, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (ESTIMATE): October 19, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 19, 2012
• Last Update Submitted That Met QC Criteria: October 17, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: PTSD; OEF/OIF Veterans; Substance Misuse; Alcohol Misuse; Web-based CBT; Integrated Primary Care
• Other Study ID Numbers: R01AA020181 (NIH)