<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/NCT01678196</url>
  </required_header>
  <id_info>
    <org_study_id>CRE 12-024</org_study_id>
    <nct_id>NCT01678196</nct_id>
  </id_info>
  <brief_title>Helping Families Help Veterans With PTSD and Alcohol Abuse: An RCT of VA-CRAFT</brief_title>
  <official_title>Helping Families Help Veterans With PTSD and Alcohol Abuse: An RCT of VA-CRAFT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project begins to evaluate the effectiveness of a web-based family outreach tool that is&#xD;
      designed to promote treatment engagement among Veterans with posttraumatic stress disorder&#xD;
      (PTSD) or alcohol use disorders (AUDs) but who have not yet engaged in mental health care.&#xD;
      The National Center for PTSD has developed an on-line, Veteran-tailored, interactive web tool&#xD;
      called VA - Community Reinforcement and Family Training (VA-CRAFT) that trains family members&#xD;
      to effectively help their Veterans to engage in treatment for PTSD and/or AUDs. This project&#xD;
      will provide preliminary information about VA-CRAFT's effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background PTSD and AUDs are highly prevalent psychiatric disorders among combat Veterans&#xD;
      that can lead to substantial impairments and disability. Although empirically supported&#xD;
      treatments are available, the majority of Veterans suffering PTSD or AUDs do not engage in&#xD;
      any mental health care. Data show that encouragement and support by family members play a key&#xD;
      role in Veterans' willingness to engage in mental health care. However, many family members&#xD;
      may not know how best to help their Veterans engage in mental health care. VA-CRAFT is an&#xD;
      innovative adaptation of an empirically supported family training intervention (CRAFT) that&#xD;
      has been shown to dramatically increase treatment engagement among substance abusing civilian&#xD;
      samples. VA-CRAFT includes Veteran-specific content, a focus on PTSD, SUDs, or both, and also&#xD;
      make use of interactive web-technology to increase its efficiency and reach. Pilot research&#xD;
      is needed to begin to evaluate the effectiveness of this adaptation of an existing,&#xD;
      efficacious intervention, to provide feedback to VA-CRAFT developers for possible&#xD;
      modifications to content and delivery, and to inform future studies.&#xD;
&#xD;
      Objectives Specific aims are to: 1) provide pilot data on the effectiveness of VA-CRAFT on&#xD;
      Veterans' mental health service utilization; 2) provide pilot data on the effectiveness of&#xD;
      VA-CRAFT on family members' wellbeing, personal quality of life, perceived relationship&#xD;
      quality with Veteran, and communication about treatment seeking; 3) obtain pilot data to&#xD;
      explore possible differences in intervention response between Veterans with AUDs only, PTSD&#xD;
      only, or both; and 4) provide information regarding potential changes in content and delivery&#xD;
      as well as mediators and moderators of outcome for VA-CRAFT.&#xD;
&#xD;
      Methods This is a randomized controlled trial of VA-CRAFT that will obtain preliminary&#xD;
      information on its effectiveness and pilot information to inform future studies. Participants&#xD;
      will be drawn from a cohort of Veterans and family members enrolled in the Readiness and&#xD;
      Resilience in National Guard Soldiers studies (RINGS; Polusny &amp; Erbes, PIs). Using Veterans'&#xD;
      responses to post-deployment RINGS surveys and administrative data, family members of&#xD;
      Veterans who screen positive for PTSD or AUDs will be recruited and divided into 1 of 3&#xD;
      subsamples: 1) family of Veterans with AUDs only (anticipated n = 38), 2) family of Veterans&#xD;
      with PTSD only (anticipated n = 72), and 3) family of Veterans with both PTSD and AUDs&#xD;
      (anticipated n = 74; total anticipated N =184 across the 3 subsamples). Family member&#xD;
      participants will complete baseline questionnaires of perceived Veteran PTSD and AUD&#xD;
      symptoms, family functioning and communication, and well-being and will be randomly assigned&#xD;
      to VA-CRAFT or Control (no treatment) conditions. Those assigned to the VA-CRAFT condition&#xD;
      will complete the online VA-CRAFT course. Progress through VA-CRAFT will be monitored and&#xD;
      stepped outreach efforts (emails, phone contacts) will be systematically used, as necessary,&#xD;
      to promote completion of the intervention. Three months after the baseline assessment, family&#xD;
      members and Veterans will complete follow-up questionnaires. Primary outcomes will include:&#xD;
      1) Veteran's mental health service utilization during the 3 months following initiation of&#xD;
      VA-CRAFT as assessed by VA administrative data and 2) family member self-reports of wellbeing&#xD;
      and quality of life and 3) family and Veteran reports of perceived relationship quality and&#xD;
      communication about treatment seeking. Effect sizes will be estimated for each outcome within&#xD;
      each subsample of participants (AUD only, PTSD only, and comorbid) and, if patterns are&#xD;
      similar within subsamples, for the sample overall. Following the post-intervention&#xD;
      questionnaires, qualitative interviews will be conducted with up to 40 family participants to&#xD;
      examine possible moderators and mediators of treatment responses and to elicit participant&#xD;
      feedback on VA-CRAFT modules and development to inform future VA-CRAFT development.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Veteran Engagement in VA Mental Health Services</measure>
    <time_frame>3 months after initiation of the intervention</time_frame>
    <description>Administrative data on mental health service utilization for Veterans will be compared for those whose family members receive the intervention (VA-CRAFT) and those who do not.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18</measure>
    <time_frame>3 months after initiation of the intervention</time_frame>
    <description>Brief Symptom Inventory - 18 (Derogatis, 1993) is an 18 item measure of general mental health symptoms and distress. The total score is used, which is the mean of 18 items rated from 0 (not at all) to 4 (extremely) distressing. Total scores range from 0 (low distress) to 4 (high distress).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Functioning</measure>
    <time_frame>3 months after the initiation of the intervention</time_frame>
    <description>Relationship Happiness Scale. The RHS is a 9 item scale of general happiness in close relationships. The total score is reported here, reflecting the mean of the 9 items rated on a scale of 1 (completely unhappy) to 10 (completely happy). Higher total scores reflect greater relationship happiness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Burden</measure>
    <time_frame>3 months post-randomization</time_frame>
    <description>Caregiver Burden Scale (CBS). The CBS is a 16 items scale assessing caregiver burden. It has 16 items rated from 1 (not at all) to 5 (extremely) distressed or burdened. Scores reported are the total scale scores, calculated as the mean of the 16 items, with a range from 1 (low burden) to 5 (high burden).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>PTSD</condition>
  <condition>Alcohol Abuse</condition>
  <arm_group>
    <arm_group_label>VA-CRAFT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family participants complete an on-line training course (VA-CRAFT) over a 3 month period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VA-CRAFT</intervention_name>
    <description>VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.</description>
    <arm_group_label>VA-CRAFT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Family participants:&#xD;
&#xD;
               -  must have participated in a Readiness and Resilience in National Guards Soldiers&#xD;
                  - (RINGS) study and be a spouse, partner, or family member of a Veteran who has&#xD;
                  also participated in a RINGS study&#xD;
&#xD;
               -  report frequent contact with the Veteran&#xD;
&#xD;
               -  be paired with a Veteran who has not received mental health services at VA or in&#xD;
                  the community for the past 3 months and who has screened positive for PTSD or&#xD;
                  AUDs&#xD;
&#xD;
               -  and have regular access to the internet.&#xD;
&#xD;
          -  Veteran participants:&#xD;
&#xD;
               -  must have participated in a RINGS study&#xD;
&#xD;
               -  be in significant contact with a spouse/partner/family member who has enrolled in&#xD;
                  this protocol&#xD;
&#xD;
               -  screened positive for PTSD and/or AUD through their responses to a RINGS survey&#xD;
&#xD;
               -  and have not received mental health care (based on VA administrative data) or in&#xD;
                  the community for the past 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Family members (and thus Veterans) will not be eligible for the study if they or their&#xD;
             Veteran have reported severe levels of interpersonal violence in their relationship in&#xD;
             the past 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher R. Erbes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Minneapolis VA Health Care System, Minneapolis, MN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Minneapolis VA Health Care System, Minneapolis, MN</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Tran T, Kuhn ER, Walser R, Drescher K. The relationship between religiosity, PTSD, and depressive symptoms in veterans in PTSD residential treatment. Journal of psychology and theology. 2012 Oct 1; 40(Winter 2012):313-322.</citation>
  </reference>
  <reference>
    <citation>Kuhn ER, Landes S. Mental and Behavioral Health Apps for Service Members, Veterans, and Providers. Society for Media Psychology &amp; Technology: The Amplifier. 2013 Apr 1; Spring/Summer(2013):8-10.</citation>
  </reference>
  <results_reference>
    <citation>Reger GM, Hoffman J, Riggs D, Rothbaum BO, Ruzek J, Holloway KM, Kuhn E. The &quot;PE coach&quot; smartphone application: an innovative approach to improving implementation, fidelity, and homework adherence during prolonged exposure. Psychol Serv. 2013 Aug;10(3):342-349. doi: 10.1037/a0032774.</citation>
    <PMID>23937084</PMID>
  </results_reference>
  <results_reference>
    <citation>Erbes CR, Stinson R, Kuhn E, Polusny M, Urban J, Hoffman J, Ruzek JI, Stepnowsky C, Thorp SR. Access, utilization, and interest in mHealth applications among veterans receiving outpatient care for PTSD. Mil Med. 2014 Nov;179(11):1218-22. doi: 10.7205/MILMED-D-14-00014.</citation>
    <PMID>25373044</PMID>
  </results_reference>
  <results_reference>
    <citation>Kuhn E, Greene C, Hoffman J, Nguyen T, Wald L, Schmidt J, Ramsey KM, Ruzek J. Preliminary evaluation of PTSD Coach, a smartphone app for post-traumatic stress symptoms. Mil Med. 2014 Jan;179(1):12-8. doi: 10.7205/MILMED-D-13-00271.</citation>
    <PMID>24402979</PMID>
  </results_reference>
  <results_reference>
    <citation>Kuhn E, Eftekhari A, Hoffman JE, Crowley JJ, Ramsey KM, Reger GM, Ruzek JI. Clinician perceptions of using a smartphone app with prolonged exposure therapy. Adm Policy Ment Health. 2014 Nov;41(6):800-7. doi: 10.1007/s10488-013-0532-2.</citation>
    <PMID>24398700</PMID>
  </results_reference>
  <results_reference>
    <citation>Ruzek JI, Eftekhari A, Rosen CS, Crowley JJ, Kuhn E, Foa EB, Hembree EA, Karlin BE. Factors related to clinician attitudes toward prolonged exposure therapy for PTSD. J Trauma Stress. 2014 Aug;27(4):423-9. doi: 10.1002/jts.21945.</citation>
    <PMID>25158635</PMID>
  </results_reference>
  <results_reference>
    <citation>Whealin JM, Kuhn E, Pietrzak RH. Applying behavior change theory to technology promoting veteran mental health care seeking. Psychol Serv. 2014 Nov;11(4):486-94. doi: 10.1037/a0037232.</citation>
    <PMID>25384001</PMID>
  </results_reference>
  <results_reference>
    <citation>Owen JE, Jaworski BK, Kuhn E, Makin-Byrd KN, Ramsey KM, Hoffman JE. mHealth in the Wild: Using Novel Data to Examine the Reach, Use, and Impact of PTSD Coach. JMIR Ment Health. 2015 Mar 25;2(1):e7. doi: 10.2196/mental.3935. eCollection 2015 Jan-Mar.</citation>
    <PMID>26543913</PMID>
  </results_reference>
  <results_reference>
    <citation>Williams EC, Gupta S, Rubinsky AD, Jones-Webb R, Bensley KM, Young JP, Hagedorn H, Gifford E, Harris AH. Racial/Ethnic Differences in the Prevalence of Clinically Recognized Alcohol Use Disorders Among Patients from the U.S. Veterans Health Administration. Alcohol Clin Exp Res. 2016 Feb;40(2):359-66. doi: 10.1111/acer.12950.</citation>
    <PMID>26842254</PMID>
  </results_reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <results_first_submitted>January 27, 2016</results_first_submitted>
  <results_first_submitted_qc>January 27, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 24, 2016</results_first_posted>
  <last_update_submitted>September 14, 2016</last_update_submitted>
  <last_update_submitted_qc>September 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Family Members</keyword>
  <keyword>Community Outreach</keyword>
  <keyword>Internet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were partners of Veterans who had screened positive for PTSD or alcohol use disorders in prior surveys with the study team. Of 287 identified eligible partners, 190 were successfully reached and 66 consented to be in the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>VA-CRAFT</title>
          <description>Family participants complete an on-line training course (VA-CRAFT) over a 3 month period&#xD;
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention&#xD;
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34">Primary outcome data was from the electronic medical record and was available for all participants.</participants>
                <participants group_id="P2" count="32">Primary outcome data was from the electronic medical record and was available for all participants.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>VA-CRAFT</title>
          <description>Family participants complete an on-line training course (VA-CRAFT) over a 3 month period&#xD;
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention&#xD;
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Veteran Engagement in VA Mental Health Services</title>
        <description>Administrative data on mental health service utilization for Veterans will be compared for those whose family members receive the intervention (VA-CRAFT) and those who do not.</description>
        <time_frame>3 months after initiation of the intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VA-CRAFT</title>
            <description>Family participants complete an on-line training course (VA-CRAFT) over a 3 month period&#xD;
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention&#xD;
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Veteran Engagement in VA Mental Health Services</title>
          <description>Administrative data on mental health service utilization for Veterans will be compared for those whose family members receive the intervention (VA-CRAFT) and those who do not.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.927</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18</title>
        <description>Brief Symptom Inventory - 18 (Derogatis, 1993) is an 18 item measure of general mental health symptoms and distress. The total score is used, which is the mean of 18 items rated from 0 (not at all) to 4 (extremely) distressing. Total scores range from 0 (low distress) to 4 (high distress).</description>
        <time_frame>3 months after initiation of the intervention</time_frame>
        <population>Group sample sizes are smaller than total sample sizes due to missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>VA-CRAFT</title>
            <description>Family participants complete an on-line training course (VA-CRAFT) over a 3 month period&#xD;
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention&#xD;
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18</title>
          <description>Brief Symptom Inventory - 18 (Derogatis, 1993) is an 18 item measure of general mental health symptoms and distress. The total score is used, which is the mean of 18 items rated from 0 (not at all) to 4 (extremely) distressing. Total scores range from 0 (low distress) to 4 (high distress).</description>
          <population>Group sample sizes are smaller than total sample sizes due to missing data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" spread="0.52"/>
                    <measurement group_id="O2" value="0.58" spread="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.67</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA reflects change from Time 1 scores (entered as covariate) to Time 2 Scores.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Family Functioning</title>
        <description>Relationship Happiness Scale. The RHS is a 9 item scale of general happiness in close relationships. The total score is reported here, reflecting the mean of the 9 items rated on a scale of 1 (completely unhappy) to 10 (completely happy). Higher total scores reflect greater relationship happiness.</description>
        <time_frame>3 months after the initiation of the intervention</time_frame>
        <population>Sample sizes are smaller than the overall sample due to missing questionnaire data.</population>
        <group_list>
          <group group_id="O1">
            <title>VA-CRAFT</title>
            <description>Family participants complete an on-line training course (VA-CRAFT) over a 3 month period&#xD;
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention&#xD;
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Family Functioning</title>
          <description>Relationship Happiness Scale. The RHS is a 9 item scale of general happiness in close relationships. The total score is reported here, reflecting the mean of the 9 items rated on a scale of 1 (completely unhappy) to 10 (completely happy). Higher total scores reflect greater relationship happiness.</description>
          <population>Sample sizes are smaller than the overall sample due to missing questionnaire data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.92" spread="1.78"/>
                    <measurement group_id="O2" value="5.75" spread="2.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.743</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA results include Time 1 scores as a covariate, thus reflecting change over time</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Caregiver Burden</title>
        <description>Caregiver Burden Scale (CBS). The CBS is a 16 items scale assessing caregiver burden. It has 16 items rated from 1 (not at all) to 5 (extremely) distressed or burdened. Scores reported are the total scale scores, calculated as the mean of the 16 items, with a range from 1 (low burden) to 5 (high burden).</description>
        <time_frame>3 months post-randomization</time_frame>
        <population>Sample sizes are smaller than total sample size due to missing questionnaire data.</population>
        <group_list>
          <group group_id="O1">
            <title>VA-CRAFT</title>
            <description>Family participants complete an on-line training course (VA-CRAFT) over a 3 month period&#xD;
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention&#xD;
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Caregiver Burden</title>
          <description>Caregiver Burden Scale (CBS). The CBS is a 16 items scale assessing caregiver burden. It has 16 items rated from 1 (not at all) to 5 (extremely) distressed or burdened. Scores reported are the total scale scores, calculated as the mean of the 16 items, with a range from 1 (low burden) to 5 (high burden).</description>
          <population>Sample sizes are smaller than total sample size due to missing questionnaire data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.56" spread="0.49"/>
                    <measurement group_id="O2" value="1.84" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>ANCOVA</method>
            <method_desc>ANCOVA reflects change for Time 1 values (entered as the covariate) to Time 2 values (entered as the DV)</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>VA-CRAFT</title>
          <description>Family participants complete an on-line training course (VA-CRAFT) over a 3 month period&#xD;
VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention&#xD;
Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Christopher Erbes, PhD</name_or_title>
      <organization>Minneapolis VA Healthcare Service Center</organization>
      <phone>612-725-2000 ext 2125</phone>
      <email>christopher.erbes@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01678196
org study id: CRE 12-024
nct id: NCT01678196
lead sponsor: 
has dmc: No
This project begins to evaluate the effectiveness of a web-based family outreach tool that is
      designed to promote treatment engagement among Veterans with posttraumatic stress disorder
      (PTSD) or alcohol use disorders (AUDs) but who have not yet engaged in mental health care.
      The National Center for PTSD has developed an on-line, Veteran-tailored, interactive web tool
      called VA - Community Reinforcement and Family Training (VA-CRAFT) that trains family members
      to effectively help their Veterans to engage in treatment for PTSD and/or AUDs. This project
      will provide preliminary information about VA-CRAFT's effectiveness.
Background PTSD and AUDs are highly prevalent psychiatric disorders among combat Veterans
      that can lead to substantial impairments and disability. Although empirically supported
      treatments are available, the majority of Veterans suffering PTSD or AUDs do not engage in
      any mental health care. Data show that encouragement and support by family members play a key
      role in Veterans' willingness to engage in mental health care. However, many family members
      may not know how best to help their Veterans engage in mental health care. VA-CRAFT is an
      innovative adaptation of an empirically supported family training intervention (CRAFT) that
      has been shown to dramatically increase treatment engagement among substance abusing civilian
      samples. VA-CRAFT includes Veteran-specific content, a focus on PTSD, SUDs, or both, and also
      make use of interactive web-technology to increase its efficiency and reach. Pilot research
      is needed to begin to evaluate the effectiveness of this adaptation of an existing,
      efficacious intervention, to provide feedback to VA-CRAFT developers for possible
      modifications to content and delivery, and to inform future studies.

      Objectives Specific aims are to: 1) provide pilot data on the effectiveness of VA-CRAFT on
      Veterans' mental health service utilization; 2) provide pilot data on the effectiveness of
      VA-CRAFT on family members' wellbeing, personal quality of life, perceived relationship
      quality with Veteran, and communication about treatment seeking; 3) obtain pilot data to
      explore possible differences in intervention response between Veterans with AUDs only, PTSD
      only, or both; and 4) provide information regarding potential changes in content and delivery
      as well as mediators and moderators of outcome for VA-CRAFT.

      Methods This is a randomized controlled trial of VA-CRAFT that will obtain preliminary
      information on its effectiveness and pilot information to inform future studies. Participants
      will be drawn from a cohort of Veterans and family members enrolled in the Readiness and
      Resilience in National Guard Soldiers studies (RINGS; Polusny & Erbes, PIs). Using Veterans'
      responses to post-deployment RINGS surveys and administrative data, family members of
      Veterans who screen positive for PTSD or AUDs will be recruited and divided into 1 of 3
      subsamples: 1) family of Veterans with AUDs only (anticipated n = 38), 2) family of Veterans
      with PTSD only (anticipated n = 72), and 3) family of Veterans with both PTSD and AUDs
      (anticipated n = 74; total anticipated N =184 across the 3 subsamples). Family member
      participants will complete baseline questionnaires of perceived Veteran PTSD and AUD
      symptoms, family functioning and communication, and well-being and will be randomly assigned
      to VA-CRAFT or Control (no treatment) conditions. Those assigned to the VA-CRAFT condition
      will complete the online VA-CRAFT course. Progress through VA-CRAFT will be monitored and
      stepped outreach efforts (emails, phone contacts) will be systematically used, as necessary,
      to promote completion of the intervention. Three months after the baseline assessment, family
      members and Veterans will complete follow-up questionnaires. Primary outcomes will include:
      1) Veteran's mental health service utilization during the 3 months following initiation of
      VA-CRAFT as assessed by VA administrative data and 2) family member self-reports of wellbeing
      and quality of life and 3) family and Veteran reports of perceived relationship quality and
      communication about treatment seeking. Effect sizes will be estimated for each outcome within
      each subsample of participants (AUD only, PTSD only, and comorbid) and, if patterns are
      similar within subsamples, for the sample overall. Following the post-intervention
      questionnaires, qualitative interviews will be conducted with up to 40 family participants to
      examine possible moderators and mediators of treatment responses and to elicit participant
      feedback on VA-CRAFT modules and development to inform future VA-CRAFT development.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Veteran Engagement in VA Mental Health Services
time frame: 3 months after initiation of the intervention
description: Administrative data on mental health service utilization for Veterans will be compared for those whose family members receive the intervention (VA-CRAFT) and those who do not.
measure: Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18
time frame: 3 months after initiation of the intervention
description: Brief Symptom Inventory - 18 (Derogatis, 1993) is an 18 item measure of general mental health symptoms and distress. The total score is used, which is the mean of 18 items rated from 0 (not at all) to 4 (extremely) distressing. Total scores range from 0 (low distress) to 4 (high distress).
measure: Family Functioning
time frame: 3 months after the initiation of the intervention
description: Relationship Happiness Scale. The RHS is a 9 item scale of general happiness in close relationships. The total score is reported here, reflecting the mean of the 9 items rated on a scale of 1 (completely unhappy) to 10 (completely happy). Higher total scores reflect greater relationship happiness.
measure: Caregiver Burden
time frame: 3 months post-randomization
description: Caregiver Burden Scale (CBS). The CBS is a 16 items scale assessing caregiver burden. It has 16 items rated from 1 (not at all) to 5 (extremely) distressed or burdened. Scores reported are the total scale scores, calculated as the mean of the 16 items, with a range from 1 (low burden) to 5 (high burden).
arm group label: VA-CRAFT
arm group type: Experimental
description: Family participants complete an on-line training course (VA-CRAFT) over a 3 month period
arm group label: Control
arm group type: Placebo Comparator
description: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
intervention type: Behavioral
intervention name: VA-CRAFT
description: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.
arm group label: VA-CRAFT
intervention type: Other
intervention name: Control
description: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Christopher R. Erbes, PhD
role: Principal Investigator
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
facility: 
country: United States
citation: Tran T, Kuhn ER, Walser R, Drescher K. The relationship between religiosity, PTSD, and depressive symptoms in veterans in PTSD residential treatment. Journal of psychology and theology. 2012 Oct 1; 40(Winter 2012):313-322.
citation: Kuhn ER, Landes S. Mental and Behavioral Health Apps for Service Members, Veterans, and Providers. Society for Media Psychology & Technology: The Amplifier. 2013 Apr 1; Spring/Summer(2013):8-10.
citation: Reger GM, Hoffman J, Riggs D, Rothbaum BO, Ruzek J, Holloway KM, Kuhn E. The "PE coach" smartphone application: an innovative approach to improving implementation, fidelity, and homework adherence during prolonged exposure. Psychol Serv. 2013 Aug;10(3):342-349. doi: 10.1037/a0032774.
PMID: 23937084
citation: Erbes CR, Stinson R, Kuhn E, Polusny M, Urban J, Hoffman J, Ruzek JI, Stepnowsky C, Thorp SR. Access, utilization, and interest in mHealth applications among veterans receiving outpatient care for PTSD. Mil Med. 2014 Nov;179(11):1218-22. doi: 10.7205/MILMED-D-14-00014.
PMID: 25373044
citation: Kuhn E, Greene C, Hoffman J, Nguyen T, Wald L, Schmidt J, Ramsey KM, Ruzek J. Preliminary evaluation of PTSD Coach, a smartphone app for post-traumatic stress symptoms. Mil Med. 2014 Jan;179(1):12-8. doi: 10.7205/MILMED-D-13-00271.
PMID: 24402979
citation: Kuhn E, Eftekhari A, Hoffman JE, Crowley JJ, Ramsey KM, Reger GM, Ruzek JI. Clinician perceptions of using a smartphone app with prolonged exposure therapy. Adm Policy Ment Health. 2014 Nov;41(6):800-7. doi: 10.1007/s10488-013-0532-2.
PMID: 24398700
citation: Ruzek JI, Eftekhari A, Rosen CS, Crowley JJ, Kuhn E, Foa EB, Hembree EA, Karlin BE. Factors related to clinician attitudes toward prolonged exposure therapy for PTSD. J Trauma Stress. 2014 Aug;27(4):423-9. doi: 10.1002/jts.21945.
PMID: 25158635
citation: Whealin JM, Kuhn E, Pietrzak RH. Applying behavior change theory to technology promoting veteran mental health care seeking. Psychol Serv. 2014 Nov;11(4):486-94. doi: 10.1037/a0037232.
PMID: 25384001
citation: Owen JE, Jaworski BK, Kuhn E, Makin-Byrd KN, Ramsey KM, Hoffman JE. mHealth in the Wild: Using Novel Data to Examine the Reach, Use, and Impact of PTSD Coach. JMIR Ment Health. 2015 Mar 25;2(1):e7. doi: 10.2196/mental.3935. eCollection 2015 Jan-Mar.
PMID: 26543913
citation: Williams EC, Gupta S, Rubinsky AD, Jones-Webb R, Bensley KM, Young JP, Hagedorn H, Gifford E, Harris AH. Racial/Ethnic Differences in the Prevalence of Clinically Recognized Alcohol Use Disorders Among Patients from the U.S. Veterans Health Administration. Alcohol Clin Exp Res. 2016 Feb;40(2):359-66. doi: 10.1111/acer.12950.
PMID: 26842254
responsible party type: Sponsor
mesh term: Alcoholism
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 