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/NCT05964998</url>
    </required_header>
    <id_info>
      <org_study_id>22-ROGE-103</org_study_id>
      <nct_id>NCT05964998</nct_id>
    </id_info>
    <brief_title>Pilot Study of CBT With tDCS for Adults Being Treated for Obsessive Compulsive Disorder</brief_title>
    <official_title>Investigating Non-invasive Brain Stimulation to Enhance CBT in Intensive Treatment-seeking Patients With OCD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rogers Behavioral Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rogers Behavioral Health</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This pilot study aims to compare the effect of transcranial direct current stimulation (tDCS)&#xD;
        versus sham stimulation, delivered immediately prior to cognitive-behavioral therapy (CBT)&#xD;
        for obsessive-compulsive disorder (OCD), on patient-reported outcomes. The investigator&#xD;
        hypothesize that patients who receive active stimulation will experience greater improvement&#xD;
        in OCD symptoms than those who receive sham stimulation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>
      <intervention_model_description>Participants randomized to either active tDCS stimulation or sham.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge</measure>
      <time_frame>Up to 12 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Quick Inventory of Depressive Symptomology from admission to discharge</measure>
      <time_frame>Up to 12 weeks</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of treatment days between admission and discharge</measure>
      <time_frame>Up to 12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Obsessive-Compulsive Inventory-Revised from admission to discharge</measure>
      <time_frame>Up to 12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Quality of life enjoyment and satisfaction questionnaire - short form from admission to discharge</measure>
      <time_frame>Up to 12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Intolerance of uncertainty scale from admission to discharge</measure>
      <time_frame>Up to 12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Subjective units of distress from admission to discharge</measure>
      <time_frame>Up to 12 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Obsessive-Compulsive Disorder</condition>
    <arm_group>
      <arm_group_label>Active stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham stimulation</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>transcranial direct current stimulation</intervention_name>
      <description>Current will increase to 1.5 milliamps within 30 seconds and then maintain for 20 minutes</description>
      <arm_group_label>Active stimulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham transcranial direct current stimulation</intervention_name>
      <description>Current will increase up to 1.5 milliamps within 30 seconds and then decrease back down over the next 30 seconds to 0 milliamps; subjects will received 0 milliamps for 20 minutes</description>
      <arm_group_label>Sham stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Primary diagnosis of Obsessive-Compulsive Disorder (OCD)&#xD;
  &#xD;
            -  Resident of state of Wisconsin&#xD;
  &#xD;
            -  Enrolled in OCD Intensive Outpatient Program (IOP) at Rogers Behavioral Health in&#xD;
               Oconomowoc, WI&#xD;
  &#xD;
            -  Ability to communicate effectively using written and spoken English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws,&#xD;
               intracranial electrodes, implanted devices/defibrillators, prostheses)&#xD;
  &#xD;
            -  Currently taking medication that reduces seizure threshold (e.g., clomipramine)&#xD;
  &#xD;
            -  Cranial pathologies (e.g., holes, plates)&#xD;
  &#xD;
            -  History of seizure or black-out concussion&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Previous treatment at Rogers Behavioral Health&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bradley C Riemann, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rogers Behavioral Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jeffrey M Engelmann, PhD</last_name>
      <phone>262-646-1851</phone>
      <email>jeff.engelmann@rogersbh.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bradley C Riemann, PhD</last_name>
      <phone>262-646-1388</phone>
      <email>bradley.riemann@rogersbh.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Rogers Behavioral Health</name>
        <address>
          <city>Oconomowoc</city>
          <state>Wisconsin</state>
          <zip>53066</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jeffrey M Engelmann, PhD</last_name>
        <phone>262-646-1851</phone>
        <email>jeff.engelmann@rogersbh.org</email>
      </contact>
      <investigator>
        <last_name>Bradley C Riemann, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jeffrey M Engelmann, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Obsessive-Compulsive Disorder</keyword>
    <keyword>OCD</keyword>
    <keyword>transcranial direct current stimulation</keyword>
    <keyword>tDCS</keyword>
    <keyword>Cognitive Behavior Therapy</keyword>
    <keyword>CBT</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Compulsive Personality Disorder</mesh_term>
      <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05964998
  org study id: 22-ROGE-103
  nct id: NCT05964998
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  This pilot study aims to compare the effect of transcranial direct current stimulation (tDCS)
        versus sham stimulation, delivered immediately prior to cognitive-behavioral therapy (CBT)
        for obsessive-compulsive disorder (OCD), on patient-reported outcomes. The investigator
        hypothesize that patients who receive active stimulation will experience greater improvement
        in OCD symptoms than those who receive sham stimulation.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants randomized to either active tDCS stimulation or sham.
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge
  time frame: Up to 12 weeks
  measure: Change in Quick Inventory of Depressive Symptomology from admission to discharge
  time frame: Up to 12 weeks
  measure: Number of treatment days between admission and discharge
  time frame: Up to 12 weeks
  measure: Change in Obsessive-Compulsive Inventory-Revised from admission to discharge
  time frame: Up to 12 weeks
  measure: Change in Quality of life enjoyment and satisfaction questionnaire - short form from admission to discharge
  time frame: Up to 12 weeks
  measure: Change in Intolerance of uncertainty scale from admission to discharge
  time frame: Up to 12 weeks
  measure: Change in Subjective units of distress from admission to discharge
  time frame: Up to 12 weeks
  arm group label: Active stimulation
  arm group type: Experimental
  arm group label: Sham stimulation
  arm group type: Sham Comparator
  intervention type: Device
  intervention name: transcranial direct current stimulation
  description: Current will increase to 1.5 milliamps within 30 seconds and then maintain for 20 minutes
  arm group label: Active stimulation
  intervention type: Device
  intervention name: Sham transcranial direct current stimulation
  description: Current will increase up to 1.5 milliamps within 30 seconds and then decrease back down over the next 30 seconds to 0 milliamps; subjects will received 0 milliamps for 20 minutes
  arm group label: Sham stimulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: No
  last name: Bradley C Riemann, PhD
  role: Principal Investigator
  affiliation: Rogers Behavioral Health
  last name: Jeffrey M Engelmann, PhD
  phone: 262-646-1851
  email: jeff.engelmann@rogersbh.org
  last name: Bradley C Riemann, PhD
  phone: 262-646-1388
  email: bradley.riemann@rogersbh.org
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Compulsive Personality Disorder
  mesh term: Obsessive-Compulsive Disorder
  sharing ipd: No