<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01710943</url>
  </required_header>
  <id_info>
    <org_study_id>R01AA020181</org_study_id>
    <nct_id>NCT01710943</nct_id>
  </id_info>
  <brief_title>Web-based CBT for Recent Veterans Experiencing Problems With Trauma Symptoms or Alcohol/Drug Use</brief_title>
  <acronym>Web CBT</acronym>
  <official_title>Web-based CBT for Substance Misusing and PTSD Symptomatic OEF/OIF Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Development and Research Institutes, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The VA Western New York Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Syracuse VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>National Development and Research Institutes, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study involves developing and evaluating an interactive, web-based CBT&#xD;
      intervention for OEF/OIF Veterans with hazardous or problematic substance use and PTSD&#xD;
      symptoms (PTSD or subsyndromal PTSD). The intervention will address the special culture and&#xD;
      experiences of the investigators targeted population (OEF/OIF Veterans). The web-based CBT&#xD;
      intervention includes 24 modules, to be used across 24 sessions targeting OEF/OIF Veterans&#xD;
      with hazardous or problematic substance use and PTSD symptoms. The investigators ask&#xD;
      participants to complete 2 sessions per week (one module per session) for 12 weeks. The first&#xD;
      18 modules to be completed across 18 sessions (9 weeks) are considered core modules relevant&#xD;
      to all Veterans in the target population. These modules are designed to reduce posttraumatic&#xD;
      stress symptoms as well as reduce and prevent the escalation of problematic substance use.&#xD;
      The remaining 6 module topics are considered &quot;optional&quot; and are used based on the interest&#xD;
      and clinical need of various sub-groups of VA patients. The study includes initial input as&#xD;
      well as feedback on a beta version from experts who have worked with OEF/OIF veterans with&#xD;
      PTSD and substance abuse problems as well as input/feedback from the target population (the&#xD;
      Veterans themselves). In addition to presenting content grounded in evidence-based CBT&#xD;
      interventions, the program also employs state of the art technologies to deliver module&#xD;
      content grounded in evidence-based learning principles, including Computer-Assisted&#xD;
      Instruction, Computer Simulation and other interactive exercises.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2010</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Anticipated">June 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PTSD Symptomatology</measure>
    <time_frame>12 weeks</time_frame>
    <description>Comparing baseline score of the PCL-M to 12 weeks score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PTSD Symptomatology</measure>
    <time_frame>1 month post-intervention</time_frame>
    <description>Comparing baseline score of the PCL-M to score 1 month post-intervention discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PTSD Symptomatology</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>Comparing baseline score of the PCL-M to score 3 months post-intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alcohol and Drug Use</measure>
    <time_frame>12 weeks</time_frame>
    <description>Comparing baseline score of the Timeline Follow-back (TLFB)to 12 weeks score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alcohol and Drug Use</measure>
    <time_frame>1 month post-intervention</time_frame>
    <description>Comparing baseline TLFB score to score 1 month post-intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alcohol and Drug Use</measure>
    <time_frame>3 month post-intervention</time_frame>
    <description>Comparing baseline TLFB score to score 3 month post-intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>12 weeks</time_frame>
    <description>Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 12 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>1 month post-intervention</time_frame>
    <description>Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 1 month post-intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>3 month post-intervention</time_frame>
    <description>Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 3 months post-intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cost-Effectiveness</measure>
    <time_frame>12 weeks</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resiliency and Positive Affect</measure>
    <time_frame>12 weeks</time_frame>
    <description>Comparing baseline Connor-Davidson Resilience Scale (CD-RISC) and the Positive Affect Negative Affect Scale (PANAS)scores to scores at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resiliency and Positive Affect</measure>
    <time_frame>1 month post-intervention</time_frame>
    <description>Comparing baseline Connor-Davidson Resilience Scale (CD-RISC) and the Positive Affect Negative Affect Scale (PANAS)scores to scores at 1 month post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resiliency and Positive Affect</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>Comparing baseline Connor-Davidson Resilience Scale (CD-RISC) and the Positive Affect Negative Affect Scale (PANAS)scores to scores at 3 months post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia</measure>
    <time_frame>12 weeks</time_frame>
    <description>Comparing baseline Insomnia Severity Index (ISI)score to score at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia</measure>
    <time_frame>1 month post-intervention</time_frame>
    <description>Comparing baseline score on the Insomnia Severity Index (ISI) to score at 1 month post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>Comparing baseline score on the Insomnia Severity Index (ISI) to score at 3 month post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Distress</measure>
    <time_frame>12 weeks</time_frame>
    <description>Comparing baseline score on the 10-item version of Symptom Checklist-90 (SCL-90) to score at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Distress</measure>
    <time_frame>1 month post-intervention</time_frame>
    <description>Comparing baseline score on the 10-item version of Symptom Checklist-90 (SCL-90) to score at 1 month post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Distress</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>Comparing baseline score on the 10-item version of Symptom Checklist-90 (SCL-90) to score at 3 months post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Severity and Pain Interference</measure>
    <time_frame>12 weeks</time_frame>
    <description>Comparing baseline score on the Brief Pain Inventory (BPI) to score at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Severity and Pain Interference</measure>
    <time_frame>1 month post-intervention</time_frame>
    <description>Comparing baseline score on the Brief Pain Inventory (BPI) to score at 1 month post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Severity and Pain Interference</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>Comparing baseline score on the Brief Pain Inventory (BPI) to score at 3 months post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Satisfaction</measure>
    <time_frame>12 weeks</time_frame>
    <description>As measured using visual analog scales assessing participant's impressions of how useful, interesting, etc. their treatment has been.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">216</enrollment>
  <condition>Post-Traumatic Stress Symptoms</condition>
  <condition>Problematic Use of Alcohol or Other Drugs</condition>
  <arm_group>
    <arm_group_label>Web-based Cognitive Behavioral Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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 &quot;core modules&quot; 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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 .</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Web-based Cognitive Behavioral Treatment</intervention_name>
    <description>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 &quot;core modules&quot; 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.</description>
    <arm_group_label>Web-based Cognitive Behavioral Treatment</arm_group_label>
    <other_name>Web-based CBT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Phase 1: Focus Groups&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 18 years of age&#xD;
&#xD;
          2. An OEF or OIF veteran (verified via CPRS)&#xD;
&#xD;
          3. Screen positive on the Audit-C (&gt;=3 for women or &gt;= 4 for men) OR screen positive on&#xD;
             the PC-PTSD (&gt;=3).&#xD;
&#xD;
          4. Currently receiving primary medical care at a VA Medical Center (verified via CPRS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Insufficient ability to understand or provide informed consent&#xD;
&#xD;
          2. Lack sufficient ability to use English to participate in the consent process,&#xD;
&#xD;
          3. Current plan or intent to harm themselves as measured with the suicide assessment in&#xD;
             Appendix D after the consent process.&#xD;
&#xD;
        Phase 2: Feedback Sessions&#xD;
&#xD;
        Inclusion Criteria&#xD;
&#xD;
          1. At least 18 years of age&#xD;
&#xD;
          2. An OEF or OIF veteran (verified via CPRS)&#xD;
&#xD;
          3. Hazardous or harmful substance use as measured by one of the following:&#xD;
&#xD;
               -  AUDIT-C score of &gt;=3 (for women) or &gt;= 4 (for men) OR&#xD;
&#xD;
               -  DAST score of &gt;=2 OR&#xD;
&#xD;
               -  Have exited a controlled environment (e.g., detoxification unit, hospital, or&#xD;
                  correctional facility) within 30 days of screening AND within 30 days prior to&#xD;
                  entering the controlled environment report:&#xD;
&#xD;
                  i. heavy drinking (&gt;3 drinks for women or &gt; 4 drinks for men on one or more&#xD;
                  days), or ii.use of any illegal drugs, iii.or misuse of prescription drugs (use&#xD;
                  in excess of the directions or any non-medical use)&#xD;
&#xD;
          4. Screen positive on the PC-PTSD (&gt;=2).&#xD;
&#xD;
          5. Currently receiving primary medical care at a VA Medical Center (verified via CPRS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Insufficient ability to understand or provide informed consent&#xD;
&#xD;
          2. Lack sufficient ability to use English to participate in the consent process, the&#xD;
             computerized intervention or the assessments.&#xD;
&#xD;
          3. Current plan or intent to harm themselves as measured with the suicide assessment in&#xD;
             Appendix D administered after the consent process.&#xD;
&#xD;
        Phase 3: Randomized Clinical Trial&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 18 years of age&#xD;
&#xD;
          2. An OEF or OIF veteran (verified via CPRS)&#xD;
&#xD;
          3. Hazardous or harmful substance use as measured by one of the following:&#xD;
&#xD;
               -  AUDIT score of &gt;=7 (for women) or &gt;= 8 (for men) OR&#xD;
&#xD;
               -  DAST score of &gt;=2 OR&#xD;
&#xD;
               -  Have exited a controlled environment (e.g., detoxification unit, hospital, or&#xD;
                  correctional facility) within 30 days of screening AND within 30 days prior to&#xD;
                  entering the controlled environment report:&#xD;
&#xD;
                  i. heavy drinking (&gt;3 drinks for women or &gt; 4 drinks for men on1 or more days) or&#xD;
                  ii. use of any illegal drugs iii. misuse of prescription drugs (use in excess of&#xD;
                  the directions or any non-medical use)&#xD;
&#xD;
          4. Determined to have diagnostic-level or PTSD (1 A symptom, 1 B symptom, 3 C symptoms&#xD;
             AND 2 D symptoms) or subthreshold PTSD (1 A symptom, 1 B symptom, 3 C symptoms OR 2 D&#xD;
             symptoms) on the Clinician Administered PTSD Scale (CAPS).&#xD;
&#xD;
          5. Currently receiving primary medical care at a VA Medical Center (verified via CPRS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Plans to move out of area within the next three months&#xD;
&#xD;
          2. Currently enrolled in a substance abuse treatment program or receiving treatment for&#xD;
             PTSD from a mental health professional (verified via CPRS).&#xD;
&#xD;
          3. Insufficient ability to understand or provide informed consent&#xD;
&#xD;
          4. Lack sufficient ability to use English to participate in the consent process, the&#xD;
             computerized intervention or the assessments.&#xD;
&#xD;
          5. In need of alcohol detoxification as determined by a score of &gt; 15 on the Clinical&#xD;
             Institute Withdrawal Assessment for Alcohol (CIWA-Ar).&#xD;
&#xD;
          6. Current plan or intent to harm themselves as measured with the suicide assessment in&#xD;
             Appendix D administered after the consent process.&#xD;
&#xD;
          7. Medical chart diagnosis of a current psychotic disorder, including schizophrenia or&#xD;
             bi-polar disorder&#xD;
&#xD;
          8. Cognitive impairment specified by a medical chart diagnosis. Diagnoses include&#xD;
             dementia and moderate to severe traumatic brain injury (TBI). Patients with mild TBI&#xD;
             will not be excluded. The Second Level TBI Assessment present in patient medical&#xD;
             records can be used to verify the severity of TBI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Rosenblum, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Development and Research Institutes, Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen Maisto, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Syracuse University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kyle Possemato, Ph.D.</last_name>
    <phone>315-425-4400</phone>
    <phone_ext>53551</phone_ext>
    <email>kyle.possemato@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michelle Acosta, Ph.D.</last_name>
    <phone>212-845-4535</phone>
    <email>acosta@ndri.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Buffalo VA Medical Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Larry Lantinga, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Syracuse VA Medical Center</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Kyle Possemato, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>April 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>October 17, 2012</last_update_submitted>
  <last_update_submitted_qc>October 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Development and Research Institutes, Inc.</investigator_affiliation>
    <investigator_full_name>Andrew Rosenblum</investigator_full_name>
    <investigator_title>Director, Institute for Treatment and Services Research</investigator_title>
  </responsible_party>
  <keyword>Web-based CBT</keyword>
  <keyword>PTSD</keyword>
  <keyword>Alcohol Misuse</keyword>
  <keyword>Substance Misuse</keyword>
  <keyword>Integrated Primary Care</keyword>
  <keyword>OEF/OIF Veterans</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01710943
org study id: R01AA020181
nct id: NCT01710943
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PTSD Symptomatology
time frame: 12 weeks
description: Comparing baseline score of the PCL-M to 12 weeks score
measure: PTSD Symptomatology
time frame: 1 month post-intervention
description: Comparing baseline score of the PCL-M to score 1 month post-intervention discharge
measure: PTSD Symptomatology
time frame: 3 months post-intervention
description: Comparing baseline score of the PCL-M to score 3 months post-intervention
measure: Alcohol and Drug Use
time frame: 12 weeks
description: Comparing baseline score of the Timeline Follow-back (TLFB)to 12 weeks score
measure: Alcohol and Drug Use
time frame: 1 month post-intervention
description: Comparing baseline TLFB score to score 1 month post-intervention
measure: Alcohol and Drug Use
time frame: 3 month post-intervention
description: Comparing baseline TLFB score to score 3 month post-intervention
measure: Quality of Life
time frame: 12 weeks
description: Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 12 weeks
measure: Quality of Life
time frame: 1 month post-intervention
description: Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 1 month post-intervention
measure: Quality of Life
time frame: 3 month post-intervention
description: Comparing baseline EuroQOl and WHOQOL-Bref scores to scores at 3 months post-intervention
measure: Cost-Effectiveness
time frame: 12 weeks
description: 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
measure: Resiliency and Positive Affect
time frame: 12 weeks
description: Comparing baseline Connor-Davidson Resilience Scale (CD-RISC) and the Positive Affect Negative Affect Scale (PANAS)scores to scores at 12 weeks
measure: Resiliency and Positive Affect
time frame: 1 month post-intervention
description: Comparing baseline Connor-Davidson Resilience Scale (CD-RISC) and the Positive Affect Negative Affect Scale (PANAS)scores to scores at 1 month post-intervention
measure: Resiliency and Positive Affect
time frame: 3 months post-intervention
description: Comparing baseline Connor-Davidson Resilience Scale (CD-RISC) and the Positive Affect Negative Affect Scale (PANAS)scores to scores at 3 months post-intervention
measure: Insomnia
time frame: 12 weeks
description: Comparing baseline Insomnia Severity Index (ISI)score to score at 12 weeks
measure: Insomnia
time frame: 1 month post-intervention
description: Comparing baseline score on the Insomnia Severity Index (ISI) to score at 1 month post-intervention
measure: Insomnia
time frame: 3 months post-intervention
description: Comparing baseline score on the Insomnia Severity Index (ISI) to score at 3 month post-intervention
measure: Psychological Distress
time frame: 12 weeks
description: Comparing baseline score on the 10-item version of Symptom Checklist-90 (SCL-90) to score at 12 weeks
measure: Psychological Distress
time frame: 1 month post-intervention
description: Comparing baseline score on the 10-item version of Symptom Checklist-90 (SCL-90) to score at 1 month post-intervention
measure: Psychological Distress
time frame: 3 months post-intervention
description: Comparing baseline score on the 10-item version of Symptom Checklist-90 (SCL-90) to score at 3 months post-intervention
measure: Pain Severity and Pain Interference
time frame: 12 weeks
description: Comparing baseline score on the Brief Pain Inventory (BPI) to score at 12 weeks
measure: Pain Severity and Pain Interference
time frame: 1 month post-intervention
description: Comparing baseline score on the Brief Pain Inventory (BPI) to score at 1 month post-intervention
measure: Pain Severity and Pain Interference
time frame: 3 months post-intervention
description: Comparing baseline score on the Brief Pain Inventory (BPI) to score at 3 months post-intervention
measure: Treatment Satisfaction
time frame: 12 weeks
description: As measured using visual analog scales assessing participant's impressions of how useful, interesting, etc. their treatment has been.
arm group label: Web-based Cognitive Behavioral Treatment
arm group type: Experimental
description: 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.
arm group label: Treatment as Usual
arm group type: No Intervention
description: 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 .
intervention type: Behavioral
intervention name: Web-based Cognitive Behavioral Treatment
description: 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.
arm group label: Web-based Cognitive Behavioral Treatment
other name: Web-based CBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Rosenblum, Ph.D.
role: Principal Investigator
affiliation: National Development and Research Institutes, Inc.
last name: Stephen Maisto, Ph.D.
role: Principal Investigator
affiliation: Syracuse University
last name: Kyle Possemato, Ph.D.
phone: 315-425-4400
phone ext: 53551
email: kyle.possemato@va.gov
last name: Michelle Acosta, Ph.D.
phone: 212-845-4535
email: acosta@ndri.org
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: National Development and Research Institutes, Inc.
investigator full name: Andrew Rosenblum
investigator title: Director, Institute for Treatment and Services Research