<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/NCT02984241</url>
  </required_header>
  <id_info>
    <org_study_id>AA024118</org_study_id>
    <nct_id>NCT02984241</nct_id>
  </id_info>
  <brief_title>e-Health Coping Skills Training for Women Whose Partner Has a Drinking Problem</brief_title>
  <official_title>eHealth Coping Skills Training for Women Whose Partner Has a Drinking Problem</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oregon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>State University of New York at Buffalo</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 evaluates web-based interventions to help women cope with the stress arising from&#xD;
      living with a problem-drinking partner&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 13, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Actual">November 30, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Beck Depression Inventory-II (BDI-II) Total Score</measure>
    <time_frame>Change in BDI score up to 12 months postintervention</time_frame>
    <description>A measure of depressive symptoms. Scores range from 0 to 63. Lower scores are indicative of better outcomes. A score of 14 or higher is considered clinically relevant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>State-Trait Anger Expression Inventory - 2 (STAXI-2, State Anger)</measure>
    <time_frame>Change in STAXI score up to 12 months postintervention</time_frame>
    <description>A measure of anger thoughts in their current state. Scores range from 1 to 60 with lower scores representing better outcomes. A score of 18 or above is considered clinically relevant.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">456</enrollment>
  <condition>Alcohol Abuse</condition>
  <arm_group>
    <arm_group_label>eHealth Coping Skills Training + Coach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Access to StopSpinningMyWheels.org + Coach Support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>eHealth Coping Skills Training Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Access to StopSpinningMyWheels.org</description>
  </arm_group>
  <arm_group>
    <arm_group_label>eHealth Usual Web Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Access to StopSpinningMyWheels.org usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eHealth Coping Skills Training</intervention_name>
    <description>Access to a specialized coping skills training website</description>
    <arm_group_label>eHealth Coping Skills Training + Coach</arm_group_label>
    <arm_group_label>eHealth Coping Skills Training Only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eHealth Usual Web Care</intervention_name>
    <description>Access to a website in which helpful information on coping that is available on the internet has been systematically collected and organized in one place for easy retrieval</description>
    <arm_group_label>eHealth Usual Web Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Coach Support</intervention_name>
    <description>Access to a professional coach by phone</description>
    <arm_group_label>eHealth Coping Skills Training + Coach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resides in New York State&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  Male partner has an alcohol problem&#xD;
&#xD;
          -  Computer access and smart phone&#xD;
&#xD;
          -  Married or cohabiting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Substance use disorder&#xD;
&#xD;
          -  Serious Mental Disorder&#xD;
&#xD;
          -  Participation in prior studies&#xD;
&#xD;
          -  Severe relationship violence&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert G Rychtarik, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University at Buffalo, Research Institute on Addictions</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brian G. Danaher, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oregon, Prevention Science Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical and Research Institute on Addiction</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
    <investigator_full_name>Robert Rychtarik</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT02984241
org study id: AA024118
nct id: NCT02984241
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates web-based interventions to help women cope with the stress arising from
      living with a problem-drinking partner
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Beck Depression Inventory-II (BDI-II) Total Score
time frame: Change in BDI score up to 12 months postintervention
description: A measure of depressive symptoms. Scores range from 0 to 63. Lower scores are indicative of better outcomes. A score of 14 or higher is considered clinically relevant.
measure: State-Trait Anger Expression Inventory - 2 (STAXI-2, State Anger)
time frame: Change in STAXI score up to 12 months postintervention
description: A measure of anger thoughts in their current state. Scores range from 1 to 60 with lower scores representing better outcomes. A score of 18 or above is considered clinically relevant.
arm group label: eHealth Coping Skills Training + Coach
arm group type: Active Comparator
description: Access to StopSpinningMyWheels.org + Coach Support
arm group label: eHealth Coping Skills Training Only
arm group type: Active Comparator
description: Access to StopSpinningMyWheels.org
arm group label: eHealth Usual Web Care
arm group type: Active Comparator
description: Access to StopSpinningMyWheels.org usual care
intervention type: Behavioral
intervention name: eHealth Coping Skills Training
description: Access to a specialized coping skills training website
arm group label: eHealth Coping Skills Training + Coach
arm group label: eHealth Coping Skills Training Only
intervention type: Behavioral
intervention name: eHealth Usual Web Care
description: Access to a website in which helpful information on coping that is available on the internet has been systematically collected and organized in one place for easy retrieval
arm group label: eHealth Usual Web Care
intervention type: Behavioral
intervention name: Coach Support
description: Access to a professional coach by phone
arm group label: eHealth Coping Skills Training + Coach
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert G Rychtarik, Ph.D.
role: Principal Investigator
affiliation: University at Buffalo, Research Institute on Addictions
last name: Brian G. Danaher, Ph.D.
role: Principal Investigator
affiliation: University of Oregon, Prevention Science Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: State University of New York at Buffalo
investigator full name: Robert Rychtarik
investigator title: Principal Investigator
mesh term: Alcoholism