<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/NCT01663337</url>
  </required_header>
  <id_info>
    <org_study_id>39884</org_study_id>
    <secondary_id>1R01AA020252</secondary_id>
    <nct_id>NCT01663337</nct_id>
  </id_info>
  <brief_title>Sequence of Symptom Change During AUD or PTSD Treatment for Comorbid PTSD/AUD</brief_title>
  <official_title>Sequence of Symptom Change During AUD (Alcohol Use or Dependence) or PTSD (Posttraumatic Stress Disorder) Treatment for Comorbid PTSD/AUD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</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>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The broad, long-term objective of the current research is to improve treatment outcomes for&#xD;
      individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol abuse and&#xD;
      dependence (AUD).&#xD;
&#xD;
      The purpose of which is to evaluate changes in both PTSD symptoms and alcohol use and&#xD;
      cravings associated with Cognitive Processing Therapy (CPT) or Relapse Prevention (RP)&#xD;
      treatment in individuals with PTSD/AUD, along with mediators and moderators of outcomes.&#xD;
&#xD;
      The study will randomize 235 PTSD/AUD participants recruited from the VA and from the&#xD;
      community to CPT, RP, or Interactive Voice Response (IVR) assessment only (AO). Those in the&#xD;
      AO condition will be re-randomized after the treatment phase to either RP or CPT. Individuals&#xD;
      will be assessed pretreatment, immediately post-treatment, 3-, 6-, 9-, and 12-months&#xD;
      post-treatment and will monitor symptoms daily throughout treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior research has established that PTSD and AUD are frequently comorbid.&#xD;
&#xD;
      Although combined treatments have been developed, they are complex and lengthy with mixed&#xD;
      results as to their efficacy. Excellent treatments exist for PTSD or AUD alone, however, it&#xD;
      has not been adequately addressed to what extent these treatments are effective in treating&#xD;
      comorbid symptom presentations. To address this research gap, the investigators will evaluate&#xD;
      two widely accepted treatments for each respective disorder; Cognitive Processing Therapy&#xD;
      (CPT) an effective PTSD treatment and Relapse Prevention (RP), a widely used effective AUD&#xD;
      treatment.&#xD;
&#xD;
      The investigators will build on our prior work using a daily telephone Interactive Voice&#xD;
      Response (IVR) system to test models of self-medication and the sequence of symptom change&#xD;
      for both primary and secondary symptom targets associated with each therapy.&#xD;
&#xD;
      Creating a more comprehensive model of symptom change in PTSD and alcohol use with widely&#xD;
      used selective treatments is critical in testing theories of PTSD/AUD, evaluating these&#xD;
      treatments for use with PTSD/AUD, and implementing these therapies with PTSD/AUD patients in&#xD;
      standard clinical practice&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>March 2013</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in PTSD Symptom Severity from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Clinician-Administered PTSD Scale (CAPS)</measure>
    <time_frame>12 Months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction in alcohol consumption from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Form-90 (Alcohol Consumption)</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety (GAD-7 &amp; OASIS)</measure>
    <time_frame>Baseline, Immediately post-treatment, 3-, 6-, 9-, 12-months post-treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn Alcohol Craving Scale (PACS)</measure>
    <time_frame>Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire Depression Scale (PHQ-9)</measure>
    <time_frame>Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">235</enrollment>
  <condition>PTSD</condition>
  <condition>Alcohol Abuse</condition>
  <condition>Alcohol Dependence</condition>
  <arm_group>
    <arm_group_label>Cognitive Processing Therapy (CPT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Relapse Prevention Therapy (RP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Assessment Only (AO)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>AO functions as a benchmark comparison condition. Consists of baseline assessment, daily interactive voice response (IVR) monitoring, and immediate post-test assessment. Not an active treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Processing Therapy (CPT)</intervention_name>
    <description>CPT is a highly structured course of therapy that focuses primarily on the cognitive restructuring of trauma related beliefs.</description>
    <arm_group_label>Cognitive Processing Therapy (CPT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relapse Prevention (RP)</intervention_name>
    <description>RP utilizes high-risk situation assessment/avoidance, drink refusal skills, assertiveness training,cognitive restructuring as well as other approaches to address issues of alcohol use/dependance.</description>
    <arm_group_label>Relapse Prevention Therapy (RP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women age ≥ 18 years with a current DSM-V diagnosis of alcohol&#xD;
             abuse/dependence&#xD;
&#xD;
          -  Recent alcohol consumption for at least 2 weeks in the past 30 day period OR at least&#xD;
             2 days of heavy drinking in the past 30 day period&#xD;
&#xD;
          -  Desire to abstain from alcohol&#xD;
&#xD;
          -  Current DSM-V (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of&#xD;
             PTSD&#xD;
&#xD;
          -  Capacity to provide informed consent&#xD;
&#xD;
          -  English fluency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men and women with an unstable psychiatric medication regimen&#xD;
&#xD;
          -  Current trauma-focused mental health treatment (MH) or behaviorally focused alcohol&#xD;
             dependence (AD) AD/MH treatment in the past 30 days&#xD;
&#xD;
          -  Suicide attempt or suicidal ideation with intent or plan, or self-harm in the past&#xD;
             month&#xD;
&#xD;
          -  Presence of a psychotic disorder or uncontrolled Bipolar Disorder&#xD;
&#xD;
          -  Signs or symptoms of alcohol withdrawal at the time of initial consent&#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>Debra Kaysen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univeristy of Washington</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tracy Simpson</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Puget Sound Health Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harborview Center for Sexual Assault and Traumatic Stress</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Puget Sound Health Care (Seattle Campus)</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Debra Kaysen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Posttraumatic Stress Disorder</keyword>
  <keyword>PTSD</keyword>
  <keyword>Alcohol Abuse</keyword>
  <keyword>Alcohol Dependance</keyword>
  <keyword>Alcoholism</keyword>
  <keyword>Comorbid</keyword>
  <keyword>Relapse Prevention (RP)</keyword>
  <keyword>Cognitive Processing Therapy (CPT)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</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/NCT01663337
org study id: 39884
secondary id: 1R01AA020252
nct id: NCT01663337
lead sponsor: 
collaborator: 
has dmc: Yes
The broad, long-term objective of the current research is to improve treatment outcomes for
      individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol abuse and
      dependence (AUD).

      The purpose of which is to evaluate changes in both PTSD symptoms and alcohol use and
      cravings associated with Cognitive Processing Therapy (CPT) or Relapse Prevention (RP)
      treatment in individuals with PTSD/AUD, along with mediators and moderators of outcomes.

      The study will randomize 235 PTSD/AUD participants recruited from the VA and from the
      community to CPT, RP, or Interactive Voice Response (IVR) assessment only (AO). Those in the
      AO condition will be re-randomized after the treatment phase to either RP or CPT. Individuals
      will be assessed pretreatment, immediately post-treatment, 3-, 6-, 9-, and 12-months
      post-treatment and will monitor symptoms daily throughout treatment.
Prior research has established that PTSD and AUD are frequently comorbid.

      Although combined treatments have been developed, they are complex and lengthy with mixed
      results as to their efficacy. Excellent treatments exist for PTSD or AUD alone, however, it
      has not been adequately addressed to what extent these treatments are effective in treating
      comorbid symptom presentations. To address this research gap, the investigators will evaluate
      two widely accepted treatments for each respective disorder; Cognitive Processing Therapy
      (CPT) an effective PTSD treatment and Relapse Prevention (RP), a widely used effective AUD
      treatment.

      The investigators will build on our prior work using a daily telephone Interactive Voice
      Response (IVR) system to test models of self-medication and the sequence of symptom change
      for both primary and secondary symptom targets associated with each therapy.

      Creating a more comprehensive model of symptom change in PTSD and alcohol use with widely
      used selective treatments is critical in testing theories of PTSD/AUD, evaluating these
      treatments for use with PTSD/AUD, and implementing these therapies with PTSD/AUD patients in
      standard clinical practice
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Reduction in PTSD Symptom Severity from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Clinician-Administered PTSD Scale (CAPS)
time frame: 12 Months
measure: Reduction in alcohol consumption from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Form-90 (Alcohol Consumption)
time frame: 12 months
measure: Anxiety (GAD-7 & OASIS)
time frame: Baseline, Immediately post-treatment, 3-, 6-, 9-, 12-months post-treatment
measure: Penn Alcohol Craving Scale (PACS)
time frame: Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment
measure: Patient Health Questionnaire Depression Scale (PHQ-9)
time frame: Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment
arm group label: Cognitive Processing Therapy (CPT)
arm group type: Active Comparator
arm group label: Relapse Prevention Therapy (RP)
arm group type: Active Comparator
arm group label: Assessment Only (AO)
arm group type: No Intervention
description: AO functions as a benchmark comparison condition. Consists of baseline assessment, daily interactive voice response (IVR) monitoring, and immediate post-test assessment. Not an active treatment
intervention type: Behavioral
intervention name: Cognitive Processing Therapy (CPT)
description: CPT is a highly structured course of therapy that focuses primarily on the cognitive restructuring of trauma related beliefs.
arm group label: Cognitive Processing Therapy (CPT)
intervention type: Behavioral
intervention name: Relapse Prevention (RP)
description: RP utilizes high-risk situation assessment/avoidance, drink refusal skills, assertiveness training,cognitive restructuring as well as other approaches to address issues of alcohol use/dependance.
arm group label: Relapse Prevention Therapy (RP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Debra Kaysen
role: Principal Investigator
affiliation: Univeristy of Washington
last name: Tracy Simpson
role: Principal Investigator
affiliation: VA Puget Sound Health Care
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Debra Kaysen
investigator title: Professor
mesh term: Alcoholism