xml: <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/NCT05989737</url>
    </required_header>
    <id_info>
      <org_study_id>13693</org_study_id>
      <nct_id>NCT05989737</nct_id>
    </id_info>
    <brief_title>A RCT of an AEBT Website for Adults With Skin Picking</brief_title>
    <official_title>A Randomized Controlled Trial of a AEBT Website for Adults With Skin Picking</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Utah State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Utah State University</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 goal of this clinical trial is to test an online intervention for adults with excoriation&#xD;
        disorder (skin picking). The main questions it aims to answer are:&#xD;
  &#xD;
          1. Is the online intervention effective, compared to a waitlist control condition?&#xD;
  &#xD;
          2. Is the online intervention acceptable to use?&#xD;
  &#xD;
        Participants will be randomized into either the online intervention or waitlist control&#xD;
        condition:&#xD;
  &#xD;
          1. Participants in the intervention condition will be asked to complete an 8 module&#xD;
             acceptance-enhanced behavioral training (AEBT) program for skin picking and 4 surveys&#xD;
             over 3 months.&#xD;
  &#xD;
          2. Participants in the waitlist condition will be asked to complete 4 surveys over 3&#xD;
             months, and will receive access to the intervention once the study is complete.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Excoriation disorder, also known as skin picking, is a chronic repetitive condition that&#xD;
        impacts an individual's daily functioning and causes clinically significant distress (Grant&#xD;
        et al., 2012). Excoriation is estimated to impact between 2-5% (Grant &amp; Chamberlain, 2020;&#xD;
        Hayes et al., 2009) of the general population, although some studies have found up to 14%&#xD;
        prevalence rates in undergraduate samples (Solley &amp; Turner, 2018). Acceptance-enhanced&#xD;
        behavioral training (AEBT; Twohig &amp; Woods, 2023), has shown promising results for targeting&#xD;
        skin picking symptoms (Asplund et al., 2021; Flessner et al., 2008). However, a recent study&#xD;
        demonstrated that mental health providers have limited knowledge of skin picking and how to&#xD;
        treat it effectively, creating a dearth of available treatment opportunities (Capel,&#xD;
        Petersen, Woods, et al., 2023).&#xD;
  &#xD;
        This study aims to address the gap in accessible evidence-based excoriation treatment by&#xD;
        examining the efficacy and feasibility of a self-guided, online program based in AEBT.&#xD;
        Participants will be recruited from across the United States from August to November 2023,&#xD;
        and will be randomized into either the online intervention group or a waitlist control&#xD;
        condition. All participants will complete online self-report assessments at baseline, mid-,&#xD;
        post-intervention, and 1 month follow-up, and waitlist participants will be provided access&#xD;
        to the program once the study is complete. For the primary aim evaluating efficacy, we&#xD;
        predict that both primary (skin picking severity) and secondary outcomes (psychological&#xD;
        flexibility, well-being, and distress) will be significantly improved in the active treatment&#xD;
        condition compared to a waitlist control group. For the secondary aim evaluating feasibility,&#xD;
        we predict that participants will report acceptable feasibility as measured through treatment&#xD;
        adherence, reports of usability, and program feedback.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 11, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Skin Picking Scale - Revised (SPS-R)</measure>
      <time_frame>12 weeks</time_frame>
      <description>The SPS-R is an 8-item self-report measure designed to assess skin picking severity over the past week. Items (e.g., &quot;How often do you feel the urge to pick your skin?&quot;) are rated on a 5-point Likert Scale with total scores ranging from 0-32. Higher scores indicate greater skin picking severity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acceptance and Action Questionnaire for Skin Picking (AAQ-SP)</measure>
      <time_frame>12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression Anxiety Stress Scale (DASS-21)</measure>
      <time_frame>12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mental Health Continuum-Short Form (MHC-SF)</measure>
      <time_frame>12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The System Usability Scale (SUS)</measure>
      <time_frame>8 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Evaluation Inventory-Short Form (TEI-SF)</measure>
      <time_frame>8 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Excoriation (Skin-Picking) Disorder</condition>
    <arm_group>
      <arm_group_label>AEBT online program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will complete the 8-module intervention of Acceptance-enhanced behavior therapy (AEBT). Acceptance-enhanced behavior therapy is a manualized treatment approach created by Woods and Twohig 2008 that provides both Acceptance and Commitment Therapy and Habit Reversal Therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Waitlist condition; only assessment</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Acceptance-Enhanced Behavior Therapy</intervention_name>
      <description>8-module intervention delivering acceptance-enhanced behavior therapy through a fully automated website. This intervention was adapted from the Acceptance-enhanced behavior therapy workbook (Woods &amp; Twohig, 2008).</description>
      <arm_group_label>AEBT online program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  currently meet criteria for DSM-5 excoriation disorder&#xD;
  &#xD;
            -  at least 18 years old at intake&#xD;
  &#xD;
            -  fluent in English&#xD;
  &#xD;
            -  reside in the United States&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  currently receiving alternative psychotherapy for skin picking&#xD;
  &#xD;
            -  modifying or starting psychotropic medication 30 days prior to starting the study&#xD;
  &#xD;
            -  currently living outside of the United States&#xD;
  &#xD;
            -  under the age of 18&#xD;
  &#xD;
            -  did not meet DSM-5 criteria for excoriation at the time of intake session&#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_contact>
      <last_name>Michael P Twohig, PhD</last_name>
      <phone>435-265-8933</phone>
      <email>michael.twohig@usu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emily M Bowers, BS</last_name>
      <phone>385-501-3270</phone>
      <email>emily.bowers@usu.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Utah State University</investigator_affiliation>
      <investigator_full_name>Michael Twohig, Ph.D.</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Acceptance and commitment therapy (ACT)</keyword>
    <keyword>Acceptance-enhanced behavioral training (AEBT)</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989737
  org study id: 13693
  nct id: NCT05989737
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test an online intervention for adults with excoriation
        disorder (skin picking). The main questions it aims to answer are:
  
          1. Is the online intervention effective, compared to a waitlist control condition?
  
          2. Is the online intervention acceptable to use?
  
        Participants will be randomized into either the online intervention or waitlist control
        condition:
  
          1. Participants in the intervention condition will be asked to complete an 8 module
             acceptance-enhanced behavioral training (AEBT) program for skin picking and 4 surveys
             over 3 months.
  
          2. Participants in the waitlist condition will be asked to complete 4 surveys over 3
             months, and will receive access to the intervention once the study is complete.
  Excoriation disorder, also known as skin picking, is a chronic repetitive condition that
        impacts an individual's daily functioning and causes clinically significant distress (Grant
        et al., 2012). Excoriation is estimated to impact between 2-5% (Grant & Chamberlain, 2020;
        Hayes et al., 2009) of the general population, although some studies have found up to 14%
        prevalence rates in undergraduate samples (Solley & Turner, 2018). Acceptance-enhanced
        behavioral training (AEBT; Twohig & Woods, 2023), has shown promising results for targeting
        skin picking symptoms (Asplund et al., 2021; Flessner et al., 2008). However, a recent study
        demonstrated that mental health providers have limited knowledge of skin picking and how to
        treat it effectively, creating a dearth of available treatment opportunities (Capel,
        Petersen, Woods, et al., 2023).
  
        This study aims to address the gap in accessible evidence-based excoriation treatment by
        examining the efficacy and feasibility of a self-guided, online program based in AEBT.
        Participants will be recruited from across the United States from August to November 2023,
        and will be randomized into either the online intervention group or a waitlist control
        condition. All participants will complete online self-report assessments at baseline, mid-,
        post-intervention, and 1 month follow-up, and waitlist participants will be provided access
        to the program once the study is complete. For the primary aim evaluating efficacy, we
        predict that both primary (skin picking severity) and secondary outcomes (psychological
        flexibility, well-being, and distress) will be significantly improved in the active treatment
        condition compared to a waitlist control group. For the secondary aim evaluating feasibility,
        we predict that participants will report acceptable feasibility as measured through treatment
        adherence, reports of usability, and program feedback.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Skin Picking Scale - Revised (SPS-R)
  time frame: 12 weeks
  description: The SPS-R is an 8-item self-report measure designed to assess skin picking severity over the past week. Items (e.g., "How often do you feel the urge to pick your skin?") are rated on a 5-point Likert Scale with total scores ranging from 0-32. Higher scores indicate greater skin picking severity.
  measure: Acceptance and Action Questionnaire for Skin Picking (AAQ-SP)
  time frame: 12 weeks
  measure: Depression Anxiety Stress Scale (DASS-21)
  time frame: 12 weeks
  measure: Mental Health Continuum-Short Form (MHC-SF)
  time frame: 12 weeks
  measure: The System Usability Scale (SUS)
  time frame: 8 weeks
  measure: Treatment Evaluation Inventory-Short Form (TEI-SF)
  time frame: 8 weeks
  arm group label: AEBT online program
  arm group type: Experimental
  description: Participants will complete the 8-module intervention of Acceptance-enhanced behavior therapy (AEBT). Acceptance-enhanced behavior therapy is a manualized treatment approach created by Woods and Twohig 2008 that provides both Acceptance and Commitment Therapy and Habit Reversal Therapy.
  arm group label: Waitlist control
  arm group type: No Intervention
  description: Waitlist condition; only assessment
  intervention type: Behavioral
  intervention name: Acceptance-Enhanced Behavior Therapy
  description: 8-module intervention delivering acceptance-enhanced behavior therapy through a fully automated website. This intervention was adapted from the Acceptance-enhanced behavior therapy workbook (Woods & Twohig, 2008).
  arm group label: AEBT online program
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael P Twohig, PhD
  phone: 435-265-8933
  email: michael.twohig@usu.edu
  last name: Emily M Bowers, BS
  phone: 385-501-3270
  email: emily.bowers@usu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Utah State University
  investigator full name: Michael Twohig, Ph.D.
  investigator title: Professor
  sharing ipd: Undecided