<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/NCT03765476</url>
  </required_header>
  <id_info>
    <org_study_id>SALIENCE</org_study_id>
    <nct_id>NCT03765476</nct_id>
  </id_info>
  <brief_title>Validation of a Training Program for Patients With Alcohol Use Disorder</brief_title>
  <official_title>Validation of a Computer-based Training Program for Patients With Alcohol Use Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Institute of Mental Health, Mannheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Institute of Mental Health, Mannheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to detect how the Web-based program SALIENCE affects patients with&#xD;
      alcohol-use Disorder in terms of craving, cognitive functions and risk of relapse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the web-based program SALIENCE (&quot;Stop Alcohol In Everyday life - New Choices and&#xD;
      Evaluations&quot;) the patient has to make decisions for non-alcoholic and against alcoholic&#xD;
      drinks. Therefore there are several scenarios, which are supposed to let the patient&#xD;
      integrate these choices into a realistic, everyday life, setting and help the patient to&#xD;
      maintain abstinence in upcoming &quot;high risk situations&quot;. It has been developed as an add-on&#xD;
      therapy to increase the overall outcome.&#xD;
&#xD;
      Participating patients with alcohol-use disorder are to receive an initial screening&#xD;
      including questionnaires and neuropsychological tests. Then the patients receive three&#xD;
      training sessions with SALIENCE each week.&#xD;
&#xD;
      After three weeks there is another examination. After these three weeks, there is a 90 day&#xD;
      period in which there are online follow-ups every two weeks to assess the craving and relapse&#xD;
      of the participants. After the 90 day period there is a third examination analog to the first&#xD;
      and the second one.&#xD;
&#xD;
      For the first 25 subjects, the follow-up and T3 will be omitted; for this collective, an&#xD;
      interim evaluation will be performed after T2 as a pilot study, followed by optimization of&#xD;
      the protocol if necessary. The first 25 subjects will all receive SALIENCE; a comparison with&#xD;
      standard therapy is not planned for this collective. There will be 2 weeks between T1 and T2&#xD;
      in the pilot study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>
    <intervention_model_description>one group receives add-on- intervention &quot;SALIENCE&quot;</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in alcohol craving</measure>
    <time_frame>directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)</time_frame>
    <description>Visual Analogue Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in attentional bias</measure>
    <time_frame>directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)</time_frame>
    <description>Dotprobe-Task (MacLeod, Mathews, &amp; Tata, 1986)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in alcohol interference</measure>
    <time_frame>directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)</time_frame>
    <description>Alcohol Stroop Test (Brand, Leichsenring-Driessen, Beblo, Kremer, &amp; Driessen, 2009)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in approach-avoidance tendencies</measure>
    <time_frame>directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)</time_frame>
    <description>Approach Avoidance Task (AAT) (R. W. Wiers et al., 2009)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relapse</measure>
    <time_frame>90 days after study inclusion</time_frame>
    <description>time to first severe relapse</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>treatment as usual</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU plus SALIENCE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treatment as usual plus computer-based intervention &quot;SALIENCE&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SALIENCE</intervention_name>
    <description>3 computer-based training sessions with program &quot;SALIENCE&quot; per week over 3 weeks (see study description)</description>
    <arm_group_label>TAU plus SALIENCE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TAU</intervention_name>
    <description>treatment as usual, , i.e. medically supervised detoxification treatment (i.e. medical management of withdrawal symptoms, associated physical discomfort and any co-existing disorders, etc.) as well as health education and supportive therapy sessions.</description>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_label>TAU plus SALIENCE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 65&#xD;
&#xD;
          -  alcohol use disorder (DSM-5)&#xD;
&#xD;
          -  inpatient or part inpatient treatment&#xD;
&#xD;
          -  alcohol abstinence for at least 72 hours and maximum for three weeks&#xD;
&#xD;
          -  normal or correctable eyesight&#xD;
&#xD;
          -  Sufficient ability to communicate with the investigators, to answer questions in oral&#xD;
             and written form&#xD;
&#xD;
          -  &quot;Fully Informed Consent&quot;&#xD;
&#xD;
          -  &quot;Written Informed Consent&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Withdrawal of the declaration of consent&#xD;
&#xD;
          -  severe internistic, neurological or psychiatric comorbidities&#xD;
&#xD;
          -  severe withdrawal symptoms (CIWA-R &gt; 7)&#xD;
&#xD;
          -  alcohol-intoxication (&gt; 0 ‰)&#xD;
&#xD;
          -  Pharmacotherapy with psychoactive substances within the last 14 days (except&#xD;
             Clomethiazole or Benzodiazepines within the alcohol withdrawal treatment; treatment&#xD;
             with these medications has to be completed within last 3 days)&#xD;
&#xD;
          -  Axis 1 disorder according to ICD-10 and DSM 5 (except tobacco use disorder and&#xD;
             specific phobia within the last 12 months)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sabine Vollstädt-Klein</last_name>
    <role>Principal Investigator</role>
    <affiliation>ZI Mannheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Württemberg</state>
        <zip>68159</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <!-- 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/NCT03765476
org study id: SALIENCE
nct id: NCT03765476
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to detect how the Web-based program SALIENCE affects patients with
      alcohol-use Disorder in terms of craving, cognitive functions and risk of relapse.
In the web-based program SALIENCE ("Stop Alcohol In Everyday life - New Choices and
      Evaluations") the patient has to make decisions for non-alcoholic and against alcoholic
      drinks. Therefore there are several scenarios, which are supposed to let the patient
      integrate these choices into a realistic, everyday life, setting and help the patient to
      maintain abstinence in upcoming "high risk situations". It has been developed as an add-on
      therapy to increase the overall outcome.

      Participating patients with alcohol-use disorder are to receive an initial screening
      including questionnaires and neuropsychological tests. Then the patients receive three
      training sessions with SALIENCE each week.

      After three weeks there is another examination. After these three weeks, there is a 90 day
      period in which there are online follow-ups every two weeks to assess the craving and relapse
      of the participants. After the 90 day period there is a third examination analog to the first
      and the second one.

      For the first 25 subjects, the follow-up and T3 will be omitted; for this collective, an
      interim evaluation will be performed after T2 as a pilot study, followed by optimization of
      the protocol if necessary. The first 25 subjects will all receive SALIENCE; a comparison with
      standard therapy is not planned for this collective. There will be 2 weeks between T1 and T2
      in the pilot study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: one group receives add-on- intervention "SALIENCE"
primary purpose: Treatment
masking: None (Open Label)
measure: Change in alcohol craving
time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
description: Visual Analogue Scale
measure: Change in attentional bias
time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
description: Dotprobe-Task (MacLeod, Mathews, & Tata, 1986)
measure: Change in alcohol interference
time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
description: Alcohol Stroop Test (Brand, Leichsenring-Driessen, Beblo, Kremer, & Driessen, 2009)
measure: Change in approach-avoidance tendencies
time frame: directly before and after each SALIENCE session (3 SALIENCE sessions per week over 3 weeks)
description: Approach Avoidance Task (AAT) (R. W. Wiers et al., 2009)
measure: Relapse
time frame: 90 days after study inclusion
description: time to first severe relapse
arm group label: TAU
arm group type: Active Comparator
description: treatment as usual
arm group label: TAU plus SALIENCE
arm group type: Experimental
description: treatment as usual plus computer-based intervention "SALIENCE"
intervention type: Behavioral
intervention name: SALIENCE
description: 3 computer-based training sessions with program "SALIENCE" per week over 3 weeks (see study description)
arm group label: TAU plus SALIENCE
intervention type: Behavioral
intervention name: TAU
description: treatment as usual, , i.e. medically supervised detoxification treatment (i.e. medical management of withdrawal symptoms, associated physical discomfort and any co-existing disorders, etc.) as well as health education and supportive therapy sessions.
arm group label: TAU
arm group label: TAU plus SALIENCE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sabine Vollstädt-Klein
role: Principal Investigator
affiliation: ZI Mannheim
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Alcohol Drinking