<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/NCT03233802</url>
  </required_header>
  <id_info>
    <org_study_id>16-211-3</org_study_id>
    <secondary_id>1R01AA024729-01A1</secondary_id>
    <nct_id>NCT03233802</nct_id>
  </id_info>
  <brief_title>Individualized Assessment and Treatment for Alcoholism II</brief_title>
  <acronym>IATP2</acronym>
  <official_title>Individualized Assessment and Treatment for Alcoholism: Treatment and Mechanisms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UConn Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>UConn Health</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>
      The object of this study is to develop a treatment for alcohol use disorders that is more&#xD;
      effective than current CB treatments. Through a 2009 R-21 pilot project the investigators&#xD;
      developed a cognitive-behavioral (CB) treatment that employed cellphone-based experience&#xD;
      sampling (ES) to collect detailed patient data, in near real-time, and that used those data&#xD;
      to direct treatment for each patient based on his/her pattern of drinking and specific coping&#xD;
      actions during high-risk situations. ES data included momentary assessments of situations,&#xD;
      thoughts and feelings antecedent to drinking episodes, and the use of coping skills. That&#xD;
      initial study of the Individualized Assessment and Treatment Program (IATP) showed promise.&#xD;
      The present study is intended to extend the earlier findings, to compare IATP to a more&#xD;
      active control treatment, and to evaluate long-term outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An 2009 R-21 pilot project developed a cognitive-behavioral treatment for alcohol use&#xD;
      disorders that employs cellphone-based experience sampling (ES) to collect detailed patient&#xD;
      data in near real-time, and uses those data to direct treatment for each patient based on&#xD;
      his/her specific patterns of drinking and specific coping actions during actual high-risk&#xD;
      situations. ES data included situations, thoughts and feelings antecedent to drinking&#xD;
      episodes, and any use of coping skills. The object was to create a CB treatment that was more&#xD;
      relevant for each patient and more effective than current treatments. In the initial study&#xD;
      the Individualized Assessment and Treatment Program (IATP) yielded better drinking rates at&#xD;
      posttreatment, and more adaptive changes in coping, than a conventional manualized CBT&#xD;
      program. Moreover, changes in drinking were partly mediated by pre-to-posttreatment changes&#xD;
      in coping with high-risk situations. Questions unanswered included:&#xD;
&#xD;
        1. Because the pilot study only collected data pre- and posttreatment, with no follow-ups,&#xD;
           it is not clear whether use of coping skills reduced drinking, or whether reduced&#xD;
           drinking led to more adaptive coping.&#xD;
&#xD;
        2. It was not known which coping skills or other factors drive outcomes in the long-term.&#xD;
&#xD;
      To answer these and other questions the investigators proposed to enroll 207 patients in a&#xD;
      full-scale trial of IATP with extended follow-ups to examine determinants of outcomes over&#xD;
      time. IATP will be compared to a more conventional packaged CB treatment (PCBT), and to a&#xD;
      Case Management Control condition (CaseM), in a dismantling design. In addition to coping, a&#xD;
      number of other possible treatment mechanisms suggested by the literature will be examined,&#xD;
      including motivation, self-efficacy, self-control, social support, alliance with the&#xD;
      therapist, AA involvement, mindfulness, and utilization of other treatment services.&#xD;
&#xD;
      By specifically training coping skills for use in high-risk for drinking situations, the&#xD;
      investigators will be able to assess how skills per se contribute to initiation and long-term&#xD;
      maintenance of behavior change. The use of ES during treatment will allow a determination of&#xD;
      what patients are actually doing, in close to real time, to initiate and maintain their own&#xD;
      sobriety. The use of ES in the follow-up period will allow the investigators to determine&#xD;
      whether coping skills that were active in initiation of reduced drinking continue to be&#xD;
      active in the long-term, as well as the extent to which other mechanisms may come into play.&#xD;
      In this way investigators can develop a clearer picture of the processes that affect outcomes&#xD;
      of CBT, and will enable clinicians to focus more precisely on the most relevant mechanisms of&#xD;
      change. Comparing IATP with PCBT will test effects of tailoring skills. The use of CaseM will&#xD;
      control for the general effects of study participation (i.e., &quot;common factors&quot;), especially&#xD;
      therapist support. The study builds on pilot data and on procedures that have already been&#xD;
      developed but not fully tested. This would be the first study to evaluate effects of&#xD;
      treatment on actual behaviors and cognitions in high-risk situations as they occur.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Actual">November 1, 2022</completion_date>
  <primary_completion_date type="Actual">November 1, 2022</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>3 Group randomized clinical trial with parallel treatments</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Investigators are blind to treatment conditions</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of days abstinent (PDA)</measure>
    <time_frame>Every 3 months from intake through 21 months</time_frame>
    <description>Proportion of days abstinent in the 90 days prior to each follow-up point</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion Heavy Drinking days (PDH)</measure>
    <time_frame>Every 3 months from intake through 21 months</time_frame>
    <description>Proportion of days in which heavy drinking occurred in the 90 days prior to each follow-up point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drinker Inventory of Consequences (DrInC) score</measure>
    <time_frame>Every 6 months from intake through 21 months</time_frame>
    <description>Negative life consequences of drinking</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">173</enrollment>
  <condition>Alcoholism</condition>
  <arm_group>
    <arm_group_label>Individualized Assess &amp; Treatment (IATP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Cognitive-Behavioral IATP consists of 12 weekly visits of individual treatment. IATP employs cellphone-based experience sampling via interactive voice response (IVR) to assess drinking, plus craving, thoughts, feelings, and coping behaviors to develop near a real-time picture of patients' high-risk situations and the ways they use to deal with them. This information will be used by the therapist and client together to problem-solve and devise adaptive coping responses to these specific high-risk situations, and develop generalized solutions to deal with other situations in the future.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Packaged Cognitive-Behavioral (PCBT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Cognitive-Behavioral PCBT consists of 12 weekly visits of individual treatment. PCBT is designed to remediate deficits in skills for coping with interpersonal (e.g., social pressure, conflict with others) and intrapersonal (e.g., craving, anger) antecedents to drinking. The treatment consists of 6 mandatory modules (e.g., managing cravings) plus 6 electives from a list of 10 (e.g., receiving criticism; scheduling pleasant activities).The treatment, based on manuals developed for our previous clinical research provides a structured experience using didactic presentations, behavioral rehearsal, and homework practice exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Case Management (CaseM)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Social and Instrumental Support CaseM is included to control for cohort and other common factors in treatment. During the 12 individual CaseM sessions the therapist and participant will identify problems in daily living that may be of concern, and consider community resources that might help in dealing with them (e.g., contacting a psychiatrist for depression, or finding a better place to live). The therapist's role is to explore the patient's concerns, help to identify goals and resources, provide verbal support, and troubleshoot difficulties that may arise in obtaining or following through with services. The support and attention to ancillary services has proven effective in reducing drinking in previous studies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individualized Assess &amp; Treatment (IATP)</intervention_name>
    <description>See previous description</description>
    <arm_group_label>Individualized Assess &amp; Treatment (IATP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Packaged Cognitive-Behavioral (PCBT)</intervention_name>
    <description>See previous description</description>
    <arm_group_label>Packaged Cognitive-Behavioral (PCBT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Case Management (CaseM)</intervention_name>
    <description>See previous description</description>
    <arm_group_label>Case Management (CaseM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be at least 18 years old,&#xD;
&#xD;
          -  Meet DSM-V criteria for Alcohol Use Disorder moderate-severe&#xD;
&#xD;
          -  Willing to accept random assignment to any of the three conditions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute medical or psychiatric problems that require inpatient treatment (e.g., acute&#xD;
             psychosis, or suicide/homicide risk)&#xD;
&#xD;
          -  Reading ability below the fifth grade level&#xD;
&#xD;
          -  Lack of reliable transportation to the treatment site, or excessive commuting&#xD;
             distance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark D Litt</last_name>
    <role>Principal Investigator</role>
    <affiliation>UConn Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UConn Health</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>November 16, 2022</last_update_submitted>
  <last_update_submitted_qc>November 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UConn Health</investigator_affiliation>
    <investigator_full_name>Mark Litt</investigator_full_name>
    <investigator_title>Professor of Behavioral Sciences</investigator_title>
  </responsible_party>
  <keyword>Alcohol Use Disorder</keyword>
  <keyword>Treatment</keyword>
  <keyword>Cognitive-Behavioral Treatment</keyword>
  <keyword>Individualized Treatment</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>
  <!-- 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/NCT03233802
org study id: 16-211-3
secondary id: 1R01AA024729-01A1
nct id: NCT03233802
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The object of this study is to develop a treatment for alcohol use disorders that is more
      effective than current CB treatments. Through a 2009 R-21 pilot project the investigators
      developed a cognitive-behavioral (CB) treatment that employed cellphone-based experience
      sampling (ES) to collect detailed patient data, in near real-time, and that used those data
      to direct treatment for each patient based on his/her pattern of drinking and specific coping
      actions during high-risk situations. ES data included momentary assessments of situations,
      thoughts and feelings antecedent to drinking episodes, and the use of coping skills. That
      initial study of the Individualized Assessment and Treatment Program (IATP) showed promise.
      The present study is intended to extend the earlier findings, to compare IATP to a more
      active control treatment, and to evaluate long-term outcomes.
An 2009 R-21 pilot project developed a cognitive-behavioral treatment for alcohol use
      disorders that employs cellphone-based experience sampling (ES) to collect detailed patient
      data in near real-time, and uses those data to direct treatment for each patient based on
      his/her specific patterns of drinking and specific coping actions during actual high-risk
      situations. ES data included situations, thoughts and feelings antecedent to drinking
      episodes, and any use of coping skills. The object was to create a CB treatment that was more
      relevant for each patient and more effective than current treatments. In the initial study
      the Individualized Assessment and Treatment Program (IATP) yielded better drinking rates at
      posttreatment, and more adaptive changes in coping, than a conventional manualized CBT
      program. Moreover, changes in drinking were partly mediated by pre-to-posttreatment changes
      in coping with high-risk situations. Questions unanswered included:

        1. Because the pilot study only collected data pre- and posttreatment, with no follow-ups,
           it is not clear whether use of coping skills reduced drinking, or whether reduced
           drinking led to more adaptive coping.

        2. It was not known which coping skills or other factors drive outcomes in the long-term.

      To answer these and other questions the investigators proposed to enroll 207 patients in a
      full-scale trial of IATP with extended follow-ups to examine determinants of outcomes over
      time. IATP will be compared to a more conventional packaged CB treatment (PCBT), and to a
      Case Management Control condition (CaseM), in a dismantling design. In addition to coping, a
      number of other possible treatment mechanisms suggested by the literature will be examined,
      including motivation, self-efficacy, self-control, social support, alliance with the
      therapist, AA involvement, mindfulness, and utilization of other treatment services.

      By specifically training coping skills for use in high-risk for drinking situations, the
      investigators will be able to assess how skills per se contribute to initiation and long-term
      maintenance of behavior change. The use of ES during treatment will allow a determination of
      what patients are actually doing, in close to real time, to initiate and maintain their own
      sobriety. The use of ES in the follow-up period will allow the investigators to determine
      whether coping skills that were active in initiation of reduced drinking continue to be
      active in the long-term, as well as the extent to which other mechanisms may come into play.
      In this way investigators can develop a clearer picture of the processes that affect outcomes
      of CBT, and will enable clinicians to focus more precisely on the most relevant mechanisms of
      change. Comparing IATP with PCBT will test effects of tailoring skills. The use of CaseM will
      control for the general effects of study participation (i.e., "common factors"), especially
      therapist support. The study builds on pilot data and on procedures that have already been
      developed but not fully tested. This would be the first study to evaluate effects of
      treatment on actual behaviors and cognitions in high-risk situations as they occur.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3 Group randomized clinical trial with parallel treatments
primary purpose: Treatment
masking: Single (Investigator)
masking description: Investigators are blind to treatment conditions
measure: Proportion of days abstinent (PDA)
time frame: Every 3 months from intake through 21 months
description: Proportion of days abstinent in the 90 days prior to each follow-up point
measure: Proportion Heavy Drinking days (PDH)
time frame: Every 3 months from intake through 21 months
description: Proportion of days in which heavy drinking occurred in the 90 days prior to each follow-up point
measure: Drinker Inventory of Consequences (DrInC) score
time frame: Every 6 months from intake through 21 months
description: Negative life consequences of drinking
arm group label: Individualized Assess & Treatment (IATP)
arm group type: Experimental
description: Intervention: Cognitive-Behavioral IATP consists of 12 weekly visits of individual treatment. IATP employs cellphone-based experience sampling via interactive voice response (IVR) to assess drinking, plus craving, thoughts, feelings, and coping behaviors to develop near a real-time picture of patients' high-risk situations and the ways they use to deal with them. This information will be used by the therapist and client together to problem-solve and devise adaptive coping responses to these specific high-risk situations, and develop generalized solutions to deal with other situations in the future.
arm group label: Packaged Cognitive-Behavioral (PCBT)
arm group type: Active Comparator
description: Intervention: Cognitive-Behavioral PCBT consists of 12 weekly visits of individual treatment. PCBT is designed to remediate deficits in skills for coping with interpersonal (e.g., social pressure, conflict with others) and intrapersonal (e.g., craving, anger) antecedents to drinking. The treatment consists of 6 mandatory modules (e.g., managing cravings) plus 6 electives from a list of 10 (e.g., receiving criticism; scheduling pleasant activities).The treatment, based on manuals developed for our previous clinical research provides a structured experience using didactic presentations, behavioral rehearsal, and homework practice exercises.
arm group label: Case Management (CaseM)
arm group type: Active Comparator
description: Intervention: Social and Instrumental Support CaseM is included to control for cohort and other common factors in treatment. During the 12 individual CaseM sessions the therapist and participant will identify problems in daily living that may be of concern, and consider community resources that might help in dealing with them (e.g., contacting a psychiatrist for depression, or finding a better place to live). The therapist's role is to explore the patient's concerns, help to identify goals and resources, provide verbal support, and troubleshoot difficulties that may arise in obtaining or following through with services. The support and attention to ancillary services has proven effective in reducing drinking in previous studies.
intervention type: Behavioral
intervention name: Individualized Assess & Treatment (IATP)
description: See previous description
arm group label: Individualized Assess & Treatment (IATP)
intervention type: Behavioral
intervention name: Packaged Cognitive-Behavioral (PCBT)
description: See previous description
arm group label: Packaged Cognitive-Behavioral (PCBT)
intervention type: Behavioral
intervention name: Case Management (CaseM)
description: See previous description
arm group label: Case Management (CaseM)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mark D Litt
role: Principal Investigator
affiliation: UConn Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: UConn Health
investigator full name: Mark Litt
investigator title: Professor of Behavioral Sciences
mesh term: Alcoholism
sharing ipd: No