Web-based CBT for Recent Veterans Experiencing Problems With Trauma Symptoms or Alcohol/Drug Use

Post-Traumatic Stress Symptoms Clinical Trial

— Web CBT  

Official title:

Web-based CBT for Substance Misusing and PTSD Symptomatic OEF/OIF Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01710943
• Other study ID #: R01AA020181
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 26, 2012
• Last updated: October 17, 2012
• Start date: September 2010
• Est. completion date: June 2014

Study information

• Verified date: October 2012
• Source: National Development and Research Institutes, Inc.
• Contact: Kyle Possemato, Ph.D.
• Phone: 315-425-4400
• Email: kyle.possemato[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Department of Veterans Affairs Office of Research Oversight (ORO)United States: Department of Health and Human Services
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Symptoms
• Problematic Use of Alcohol or Other Drugs

Intervention

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.

Locations

Country	Name	City	State
United States	Buffalo VA Medical Center	Buffalo	New York
United States	Syracuse VA Medical Center	Syracuse	New York

Sponsors (3)

Lead Sponsor	Collaborator
National Development and Research Institutes, Inc.	Syracuse VA Medical Center, The VA Western New York Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptomatology	Comparing baseline score of the PCL-M to 12 weeks score	12 weeks	No
Primary	PTSD Symptomatology	Comparing baseline score of the PCL-M to score 1 month post-intervention discharge	1 month post-intervention	No
Primary	PTSD Symptomatology	Comparing baseline score of the PCL-M to score 3 months post-intervention	3 months post-intervention	No
Primary	Alcohol and Drug Use	Comparing baseline score of the Timeline Follow-back (TLFB)to 12 weeks score	12 weeks	No
Primary	Alcohol and Drug Use	Comparing baseline TLFB score to score 1 month post-intervention	1 month post-intervention	No
Primary	Alcohol and Drug Use	Comparing baseline TLFB score to score 3 month post-intervention	3 month post-intervention	No
Primary	Quality of Life	Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 12 weeks	12 weeks	No
Primary	Quality of Life	Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 1 month post-intervention	1 month post-intervention	No
Primary	Quality of Life	Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 3 months post-intervention	3 month post-intervention	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Insomnia	Comparing baseline Insomnia Severity Index (ISI)score to score at 12 weeks	12 weeks	No
Secondary	Insomnia	Comparing baseline score on the Insomnia Severity Index (ISI) to score at 1 month post-intervention	1 month post-intervention	No
Secondary	Insomnia	Comparing baseline score on the Insomnia Severity Index (ISI) to score at 3 month post-intervention	3 months post-intervention	No
Secondary	Psychological Distress	Comparing baseline score on the 10-item version of Symptom Checklist-90 (SCL-90) to score at 12 weeks	12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Pain Severity and Pain Interference	Comparing baseline score on the Brief Pain Inventory (BPI) to score at 12 weeks	12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Treatment Satisfaction	As measured using visual analog scales assessing participant's impressions of how useful, interesting, etc. their treatment has been.	12 weeks	No