<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/NCT04455152</url>
  </required_header>
  <id_info>
    <org_study_id>Mellon2020CAS</org_study_id>
    <nct_id>NCT04455152</nct_id>
  </id_info>
  <brief_title>Self-control and Body-focused Repetitive Behaviors</brief_title>
  <official_title>Self-control Intervention to Increase Adherence to Web-based Self-help for Body-focused Repetitive Behaviors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American 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>
      Web-based self-help could work well to disseminate behavior therapies for body-focused&#xD;
      repetitive behaviors (BFRB) such as hair pulling and skin picking. Previous research suggests&#xD;
      that this method works well for people who use the program a great deal, but many&#xD;
      participants do not. Adhering frequently to a BFRB self-help program requires self-control&#xD;
      because the costs occur immediately (time, trouble, possible boredom), whereas the benefits&#xD;
      (reduced symptoms) are realized later.&#xD;
&#xD;
      This study will test whether two weeks of practice of a self-control exercise (avoiding&#xD;
      consumption of sweet foods), compared to wait list, will increase adherence during a&#xD;
      subsequent 10-week trial of BFRB self-help.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Body-focused repetitive behaviors (BFRB) such as hair pulling and skin picking are prevalent&#xD;
      and associated with distress and impairment. Behavioral treatments of BFRB are effective, but&#xD;
      access to therapists with expertise in them is limited. One way to reduce the access problem&#xD;
      is to disseminate evidence-based treatments in the form of web-based self-help programs.&#xD;
      Behavior therapy methods are incorporated in such programs for hair pulling and skin picking,&#xD;
      each of which appears promising based on uncontrolled studies. The investigators conducted&#xD;
      the first randomized controlled trial of stop pulling.com. Compared to wait list, those with&#xD;
      access to the program showed a small but significant advantage in reduction of&#xD;
      interviewer-rated TTM symptoms. However, there was no significant difference from wait list&#xD;
      on self-reported symptoms, alopecia [hair loss severity], impairment, or quality of life.&#xD;
&#xD;
      Average outcomes of stop pulling.com were thus modest, but the investigators see a couple of&#xD;
      ways to extend this work in the proposed project. First, the coverage of BFRB is expanded by&#xD;
      including stop picking.com. Second, web-based self-help will be tested as a free-standing&#xD;
      intervention, the way it is offered to the public. In the previous research, stop pulling.com&#xD;
      was the first phase of a stepped care program, to be followed [if desired] by in-person&#xD;
      therapy. This could have biased the sample by limiting it to residents of the Washington, DC&#xD;
      area and by attracting some who were not interested in web-based self-help and only wanted&#xD;
      the in-person therapy. Consistent with this concern, 19% of participants never tried the&#xD;
      self-help program. Third and most importantly, a preliminary self-control intervention&#xD;
      intended to increase adherence to web-based self-help will be tested. Nonadherence is the&#xD;
      main problem for self-help in behavioral health in general, and in BFRB in particular. In the&#xD;
      earllier study of stop pulling.com, participants logged on and entered data on a median of&#xD;
      just 12.5 days (out of the intended 70) in a 10-week span. Those who used it more tended to&#xD;
      get more benefit, but the challenge is how to increase adherence overall.&#xD;
&#xD;
      Adherence to web-based self-help may be seen as requiring self-control because its costs are&#xD;
      borne immediately (e.g., somewhat tedious assessments such as self-monitoring logs), whereas&#xD;
      the benefits are probabilistic and delayed (reduction of symptoms over a period of weeks).&#xD;
      Just as someone taking up a new exercise routine has to do something effortful and perhaps&#xD;
      disagreeable at first in order to (likely) gain later benefits, so too the person with a BFRB&#xD;
      needs to log data regarding urges or pulling/picking episodes in a meticulous manner in the&#xD;
      hope of eventually getting useful individualized suggestions, implementing them, and&#xD;
      (probably) reducing symptom severity. The method for improving self-control to be tested in&#xD;
      this project derives from the &quot;strength&quot; model of self-control, in which willpower is&#xD;
      considered analogous to a muscle. Research supports two key implications of this model, that&#xD;
      exertion of self-control temporarily depletes capacity and impairs performance on other tasks&#xD;
      (e.g., holding a hand grip as long as one can makes it harder to choose a healthy snack&#xD;
      rather than chocolate), but that practicing self-control builds up self-control strength over&#xD;
      time.&#xD;
&#xD;
      Approach: In this study 40 participants (20 hair pullers, 20 skin pickers-10 of each in each&#xD;
      experimental condition) will be randomly assigned after a pretest of BFRB severity to one of&#xD;
      two conditions: (a) 2-week self-control task vs. (b) 2-week wait list, followed in each&#xD;
      condition by paid access to web-based self-help for 10 weeks and then post-test. The&#xD;
      self-control intervention asks the participant to avoid eating sweet foods and to report via&#xD;
      email each day how well they were able to do so. Smokers who performed this task were&#xD;
      significantly better able to maintain abstinence after smoking cessation than were those in a&#xD;
      control condition. The main dependent variable will be adherence, the number of days (out of&#xD;
      70) on which the participant logged in and entered data on their behavior. Secondary outcomes&#xD;
      include change in BFRB symptoms and qualitative feedback on the self-control task and the&#xD;
      self-help program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">November 4, 2022</completion_date>
  <primary_completion_date type="Actual">November 4, 2022</primary_completion_date>
  <phase>Phase 1</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>Participants are randomly assigned to self-control vs. wait list for 2 weeks after baseline assessment and before all receive 10 weeks of web-based self-help.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Random assignment will not be made, nor known to anyone, until informed consent process and baseline assessment are completed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence</measure>
    <time_frame>10 weeks</time_frame>
    <description>number of days (of maximum 70) on which participant logged into self-help program and entered data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BFRB symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>depending on participant's primary problem, either hairpulling or skin picking severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>program feedback</measure>
    <time_frame>week 12 only</time_frame>
    <description>qualitative feedback on self-control task and on web-based self-help</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Trichotillomania (Hair-Pulling Disorder)</condition>
  <condition>Skin-Picking</condition>
  <arm_group>
    <arm_group_label>Self-control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>two-week period of practicing self-control (attempting to avoid eating sweet foods) and self-monitoring success in doing so</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wait list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>waiting 2 weeks after baseline assessment before gaining access to web-based self-help</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>self-control</intervention_name>
    <description>avoiding eating sweets as a way of building self-control strength</description>
    <arm_group_label>Self-control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  meet the diagnostic criteria for either Hair Pulling Disorder (trichotillomania) or&#xD;
             Skin Picking Disorder&#xD;
&#xD;
          -  have regular access to the Internet&#xD;
&#xD;
          -  age 18 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        [all current, not lifetime]&#xD;
&#xD;
          -  suicidal thoughts&#xD;
&#xD;
          -  major depression&#xD;
&#xD;
          -  psychosis&#xD;
&#xD;
          -  severe anxiety&#xD;
&#xD;
          -  substance abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>American University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20016</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>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>American University</investigator_affiliation>
    <investigator_full_name>David A. F. Haaga</investigator_full_name>
    <investigator_title>Professor of Psychology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trichotillomania</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data could be shared with other researchers</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>a year after completion of data collection, available indefinitely</ipd_time_frame>
    <ipd_access_criteria>Any faculty member, or graduate student collaborating with a faculty member.</ipd_access_criteria>
  </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/NCT04455152
org study id: Mellon2020CAS
nct id: NCT04455152
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Web-based self-help could work well to disseminate behavior therapies for body-focused
      repetitive behaviors (BFRB) such as hair pulling and skin picking. Previous research suggests
      that this method works well for people who use the program a great deal, but many
      participants do not. Adhering frequently to a BFRB self-help program requires self-control
      because the costs occur immediately (time, trouble, possible boredom), whereas the benefits
      (reduced symptoms) are realized later.

      This study will test whether two weeks of practice of a self-control exercise (avoiding
      consumption of sweet foods), compared to wait list, will increase adherence during a
      subsequent 10-week trial of BFRB self-help.
Body-focused repetitive behaviors (BFRB) such as hair pulling and skin picking are prevalent
      and associated with distress and impairment. Behavioral treatments of BFRB are effective, but
      access to therapists with expertise in them is limited. One way to reduce the access problem
      is to disseminate evidence-based treatments in the form of web-based self-help programs.
      Behavior therapy methods are incorporated in such programs for hair pulling and skin picking,
      each of which appears promising based on uncontrolled studies. The investigators conducted
      the first randomized controlled trial of stop pulling.com. Compared to wait list, those with
      access to the program showed a small but significant advantage in reduction of
      interviewer-rated TTM symptoms. However, there was no significant difference from wait list
      on self-reported symptoms, alopecia [hair loss severity], impairment, or quality of life.

      Average outcomes of stop pulling.com were thus modest, but the investigators see a couple of
      ways to extend this work in the proposed project. First, the coverage of BFRB is expanded by
      including stop picking.com. Second, web-based self-help will be tested as a free-standing
      intervention, the way it is offered to the public. In the previous research, stop pulling.com
      was the first phase of a stepped care program, to be followed [if desired] by in-person
      therapy. This could have biased the sample by limiting it to residents of the Washington, DC
      area and by attracting some who were not interested in web-based self-help and only wanted
      the in-person therapy. Consistent with this concern, 19% of participants never tried the
      self-help program. Third and most importantly, a preliminary self-control intervention
      intended to increase adherence to web-based self-help will be tested. Nonadherence is the
      main problem for self-help in behavioral health in general, and in BFRB in particular. In the
      earllier study of stop pulling.com, participants logged on and entered data on a median of
      just 12.5 days (out of the intended 70) in a 10-week span. Those who used it more tended to
      get more benefit, but the challenge is how to increase adherence overall.

      Adherence to web-based self-help may be seen as requiring self-control because its costs are
      borne immediately (e.g., somewhat tedious assessments such as self-monitoring logs), whereas
      the benefits are probabilistic and delayed (reduction of symptoms over a period of weeks).
      Just as someone taking up a new exercise routine has to do something effortful and perhaps
      disagreeable at first in order to (likely) gain later benefits, so too the person with a BFRB
      needs to log data regarding urges or pulling/picking episodes in a meticulous manner in the
      hope of eventually getting useful individualized suggestions, implementing them, and
      (probably) reducing symptom severity. The method for improving self-control to be tested in
      this project derives from the "strength" model of self-control, in which willpower is
      considered analogous to a muscle. Research supports two key implications of this model, that
      exertion of self-control temporarily depletes capacity and impairs performance on other tasks
      (e.g., holding a hand grip as long as one can makes it harder to choose a healthy snack
      rather than chocolate), but that practicing self-control builds up self-control strength over
      time.

      Approach: In this study 40 participants (20 hair pullers, 20 skin pickers-10 of each in each
      experimental condition) will be randomly assigned after a pretest of BFRB severity to one of
      two conditions: (a) 2-week self-control task vs. (b) 2-week wait list, followed in each
      condition by paid access to web-based self-help for 10 weeks and then post-test. The
      self-control intervention asks the participant to avoid eating sweet foods and to report via
      email each day how well they were able to do so. Smokers who performed this task were
      significantly better able to maintain abstinence after smoking cessation than were those in a
      control condition. The main dependent variable will be adherence, the number of days (out of
      70) on which the participant logged in and entered data on their behavior. Secondary outcomes
      include change in BFRB symptoms and qualitative feedback on the self-control task and the
      self-help program.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomly assigned to self-control vs. wait list for 2 weeks after baseline assessment and before all receive 10 weeks of web-based self-help.
primary purpose: Treatment
masking: Single (Investigator)
masking description: Random assignment will not be made, nor known to anyone, until informed consent process and baseline assessment are completed.
measure: Adherence
time frame: 10 weeks
description: number of days (of maximum 70) on which participant logged into self-help program and entered data
measure: BFRB symptoms
time frame: 12 weeks
description: depending on participant's primary problem, either hairpulling or skin picking severity
measure: program feedback
time frame: week 12 only
description: qualitative feedback on self-control task and on web-based self-help
arm group label: Self-control
arm group type: Experimental
description: two-week period of practicing self-control (attempting to avoid eating sweet foods) and self-monitoring success in doing so
arm group label: wait list
arm group type: No Intervention
description: waiting 2 weeks after baseline assessment before gaining access to web-based self-help
intervention type: Behavioral
intervention name: self-control
description: avoiding eating sweets as a way of building self-control strength
arm group label: Self-control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: American University
investigator full name: David A. F. Haaga
investigator title: Professor of Psychology
mesh term: Trichotillomania
sharing ipd: Yes
ipd description: De-identified data could be shared with other researchers
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: a year after completion of data collection, available indefinitely
ipd access criteria: Any faculty member, or graduate student collaborating with a faculty member.