<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/NCT01679457</url>
  </required_header>
  <id_info>
    <org_study_id>2012-P-001010/1; McLean</org_study_id>
    <nct_id>NCT01679457</nct_id>
  </id_info>
  <brief_title>Assessing Models of Exposure Therapy</brief_title>
  <official_title>Assessing Models of Exposure Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mclean Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Utah State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mclean Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to learn how to improve treatment for clients who are working&#xD;
      hard in treatment at the McLean Hospital Obsessive Compulsive Disorder Institute (OCDI), but&#xD;
      who are not making the progress that would typically be expected. Therefore, the&#xD;
      investigators will be comparing the performance of such clients in a treatment as usual&#xD;
      (TAU)-Exposure and Response Prevention (ERP) session with their performance in an Acceptance&#xD;
      and Commitment Therapy (ACT)-focused ERP session that follows an ACT booster session. The&#xD;
      investigators hypothesize that clients will perform significantly better in the ACT-focused&#xD;
      ERP session than they will in the TAU-ERP session. More specifically, the investigators&#xD;
      hypothesize that clients and an independent rater will report that in the ACT-focused ERP&#xD;
      session, clients performed significantly fewer rituals and/or avoidance behaviors,&#xD;
      experienced comparable levels of distress, exerted significantly more effort, had&#xD;
      significantly less difficulty getting started with the ERP, were significantly less&#xD;
      influenced by their uncomfortable thoughts/feelings, were significantly more willing to&#xD;
      experience discomfort, were significantly more focused on working towards what is important&#xD;
      to the client. The investigators also hypothesize that an independent rater will rate clients&#xD;
      as significantly more compliant with the ACT-focused ERP session than with the TAU-ERP&#xD;
      session. The investigators also hypothesize that clients will rate the ACT-focused ERP&#xD;
      session as significantly more preferable and acceptable than the TAU-ERP session, and that&#xD;
      they will report being significantly more willing to do the ACT-focused ERP session again.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">August 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Client Post-ERP Session Questions (Day 1).</measure>
    <time_frame>Client Post-ERP Session Questions (Day 1) will be administered immediately after the &quot;Day 1&quot; TAU-ERP session.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Client Post-ERP Session Questions (Day 2).</measure>
    <time_frame>Client Post-ERP Session Questions (Day 2) will be administered immediately after the &quot;Day 2&quot; ACT-focused ERP session.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Obsessive-compulsive Disorders and Symptoms</condition>
  <arm_group>
    <arm_group_label>ACT-Focused ERP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One Session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU-ERP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One Session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ACT-Focused ERP</intervention_name>
    <arm_group_label>TAU-ERP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TAU-ERP</intervention_name>
    <arm_group_label>ACT-Focused ERP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants will be adults at least 18 years of age currently enrolled in the&#xD;
             residential or day treatment program at the OCDI.&#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>Nate G Gruner, LICSW</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mclean Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Obsessive Compulsive Disorder Institute at McLean Hospital</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>August 22, 2022</last_update_submitted>
  <last_update_submitted_qc>August 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mclean Hospital</investigator_affiliation>
    <investigator_full_name>Nate Gruner</investigator_full_name>
    <investigator_title>Staff Behavior Therapist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obsessive-Compulsive Disorder</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/NCT01679457
org study id: 2012-P-001010/1; McLean
nct id: NCT01679457
lead sponsor: 
collaborator: 
has dmc: Yes
The objective of this study is to learn how to improve treatment for clients who are working
      hard in treatment at the McLean Hospital Obsessive Compulsive Disorder Institute (OCDI), but
      who are not making the progress that would typically be expected. Therefore, the
      investigators will be comparing the performance of such clients in a treatment as usual
      (TAU)-Exposure and Response Prevention (ERP) session with their performance in an Acceptance
      and Commitment Therapy (ACT)-focused ERP session that follows an ACT booster session. The
      investigators hypothesize that clients will perform significantly better in the ACT-focused
      ERP session than they will in the TAU-ERP session. More specifically, the investigators
      hypothesize that clients and an independent rater will report that in the ACT-focused ERP
      session, clients performed significantly fewer rituals and/or avoidance behaviors,
      experienced comparable levels of distress, exerted significantly more effort, had
      significantly less difficulty getting started with the ERP, were significantly less
      influenced by their uncomfortable thoughts/feelings, were significantly more willing to
      experience discomfort, were significantly more focused on working towards what is important
      to the client. The investigators also hypothesize that an independent rater will rate clients
      as significantly more compliant with the ACT-focused ERP session than with the TAU-ERP
      session. The investigators also hypothesize that clients will rate the ACT-focused ERP
      session as significantly more preferable and acceptable than the TAU-ERP session, and that
      they will report being significantly more willing to do the ACT-focused ERP session again.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Client Post-ERP Session Questions (Day 1).
time frame: Client Post-ERP Session Questions (Day 1) will be administered immediately after the "Day 1" TAU-ERP session.
measure: Client Post-ERP Session Questions (Day 2).
time frame: Client Post-ERP Session Questions (Day 2) will be administered immediately after the "Day 2" ACT-focused ERP session.
arm group label: ACT-Focused ERP
arm group type: Experimental
description: One Session.
arm group label: TAU-ERP
arm group type: Active Comparator
description: One Session.
intervention type: Behavioral
intervention name: ACT-Focused ERP
arm group label: TAU-ERP
intervention type: Behavioral
intervention name: TAU-ERP
arm group label: ACT-Focused ERP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nate G Gruner, LICSW
role: Principal Investigator
affiliation: Mclean Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mclean Hospital
investigator full name: Nate Gruner
investigator title: Staff Behavior Therapist
mesh term: Obsessive-Compulsive Disorder