<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/NCT02216981</url>
  </required_header>
  <id_info>
    <org_study_id>MILSALK1</org_study_id>
    <nct_id>NCT02216981</nct_id>
  </id_info>
  <brief_title>Examining the Feasibility and Acceptability of Good Quality Intensive CBT for OCD and Good Quality Weekly CBT for OCD</brief_title>
  <official_title>A Pilot Randomised Controlled Trial to Assess the Feasibility of Cognitive Behavioural Therapy (CBT) Delivered in Time-Intensive and Weekly Treatment Formats for Treatment Resistant Obsessive Compulsive Disorder (OCD).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bath</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>South London and Maudsley NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Avon and Wiltshire Mental Health Partnership NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bath</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine how feasible and acceptable it is to deliver a&#xD;
      talking treatment called Cognitive Behavioural Therapy (CBT) in two different formats for&#xD;
      people who have had treatment for OCD in the past but it didn't work out for them.&#xD;
&#xD;
      The two different treatment formats are CBT delivered on a weekly basis (which is&#xD;
      approximately 12-18 hours of therapy delivered weekly for 60-90 minutes each session,&#xD;
      followed by 1-3 monthly follow up sessions as needed) and CBT offered in an intensive format&#xD;
      (which is having approximately 12-18 hours of therapy all in a 3-week period, followed by 1-3&#xD;
      monthly follow up sessions as needed).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main aim of this study is to assess the feasibility and acceptability of Intensive CBT&#xD;
      for treatment resistant OCD when participants are randomized to this format.&#xD;
&#xD;
      This study aims to establish an estimate of the relative efficacy of both Intensive and&#xD;
      Weekly CBT when compared individually to wait list, for participants with a diagnosis of OCD,&#xD;
      who have previously not responded to CBT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">December 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Yale- Brown Obsessive Compulsive Scale (Y-BOCS) &amp; Obsessive Compulsive Inventory</measure>
    <time_frame>Assessment, end of treatment (at 3 weeks for Intensive &amp; 12-15 weeks for weekly treatment) and follow up (at 3 &amp; 6 months post treatment completion for both groups).</time_frame>
    <description>The Y-BOCS is Clinician administered and the OCI is self report, both measures assess the severity of OCD symptoms.&#xD;
These measures will be used to assess change in symptom severity from base line to end of treatment and to assess if there has been a change at end of treatment, if this is maintained at 3 and 6 months following the completion of treatment.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Obsessive Compulsive Disorder (OCD)</condition>
  <arm_group>
    <arm_group_label>Intensive Cognitive Behavioural Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intensive CBT (an average of 12-18 hours of CBT offered in an intensive format, delivered on 2-3 days per week over a period of 3 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weekly Cognitive Behavioural Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Weekly CBT (an average of 12-18 hours of CBT delivered in 60-90 minute sessions on a weekly basis)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Wait list (3 months). Participants randomized to wait list will commence treatment after 3 months, in the treatment condition to which they are re-randomized (either Intensive or Weekly CBT).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioural Therapy (CBT)</intervention_name>
    <arm_group_label>Intensive Cognitive Behavioural Therapy</arm_group_label>
    <arm_group_label>Weekly Cognitive Behavioural Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary diagnosis of OCD (as confirmed by the administration of the Structured&#xD;
             Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th ed.)&#xD;
             (DSM-IV) (SCID-I) .&#xD;
&#xD;
          -  Participant identifies their main problem as OCD.&#xD;
&#xD;
          -  Participant has not responded to one or more trials CBT&#xD;
&#xD;
          -  Yale-Brown Obsessive Compulsive Scale (YBOCS) score of 16 or above.&#xD;
&#xD;
          -  No change in psychotropic medication (if applicable) for at least 8 weeks prior to&#xD;
             study entry. (If such a change has taken place there will be an option for the&#xD;
             participant to take part once the medication has been stabilised).&#xD;
&#xD;
          -  No intention to change psychotropic medication during the course of the trial&#xD;
&#xD;
          -  Able to speak and read every day English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe psychiatric problem that requires separate treatment at an immediate basis and&#xD;
             is linked to risk.&#xD;
&#xD;
          -  Drug and/or alcohol dependence in last three months&#xD;
&#xD;
          -  History of Psychosis or Bipolar Disorder&#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>Josie FA Millar</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bath</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul M Salkovskis</last_name>
    <role>Study Director</role>
    <affiliation>University of Bath</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Anxiety Disorders and Trauma (CADAT)</name>
      <address>
        <city>London</city>
        <state>Denmark Hill</state>
        <zip>SE5 8AZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for Specialist Psychological Treatments of Anxiety and Related Problems (CSPTARP)</name>
      <address>
        <city>Bath</city>
        <zip>BA2 7AY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>October 25, 2016</last_update_submitted>
  <last_update_submitted_qc>October 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bath</investigator_affiliation>
    <investigator_full_name>Josie Millar</investigator_full_name>
    <investigator_title>Lecturer &amp; Clinical Psychologist</investigator_title>
  </responsible_party>
  <keyword>Obsessive Compulsive Disorder (OCD)</keyword>
  <keyword>Cognitive Behavioural Therapy (CBT)</keyword>
  <keyword>Intensive therapy</keyword>
  <keyword>Intensive treatment</keyword>
  <keyword>Treatment Resistant</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>
  <!-- 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/NCT02216981
org study id: MILSALK1
nct id: NCT02216981
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to examine how feasible and acceptable it is to deliver a
      talking treatment called Cognitive Behavioural Therapy (CBT) in two different formats for
      people who have had treatment for OCD in the past but it didn't work out for them.

      The two different treatment formats are CBT delivered on a weekly basis (which is
      approximately 12-18 hours of therapy delivered weekly for 60-90 minutes each session,
      followed by 1-3 monthly follow up sessions as needed) and CBT offered in an intensive format
      (which is having approximately 12-18 hours of therapy all in a 3-week period, followed by 1-3
      monthly follow up sessions as needed).
The main aim of this study is to assess the feasibility and acceptability of Intensive CBT
      for treatment resistant OCD when participants are randomized to this format.

      This study aims to establish an estimate of the relative efficacy of both Intensive and
      Weekly CBT when compared individually to wait list, for participants with a diagnosis of OCD,
      who have previously not responded to CBT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Yale- Brown Obsessive Compulsive Scale (Y-BOCS) & Obsessive Compulsive Inventory
time frame: Assessment, end of treatment (at 3 weeks for Intensive & 12-15 weeks for weekly treatment) and follow up (at 3 & 6 months post treatment completion for both groups).
description: The Y-BOCS is Clinician administered and the OCI is self report, both measures assess the severity of OCD symptoms.
These measures will be used to assess change in symptom severity from base line to end of treatment and to assess if there has been a change at end of treatment, if this is maintained at 3 and 6 months following the completion of treatment.
arm group label: Intensive Cognitive Behavioural Therapy
arm group type: Experimental
description: Intensive CBT (an average of 12-18 hours of CBT offered in an intensive format, delivered on 2-3 days per week over a period of 3 weeks)
arm group label: Weekly Cognitive Behavioural Therapy
arm group type: Active Comparator
description: Weekly CBT (an average of 12-18 hours of CBT delivered in 60-90 minute sessions on a weekly basis)
arm group label: Wait list
arm group type: No Intervention
description: Wait list (3 months). Participants randomized to wait list will commence treatment after 3 months, in the treatment condition to which they are re-randomized (either Intensive or Weekly CBT).
intervention type: Behavioral
intervention name: Cognitive Behavioural Therapy (CBT)
arm group label: Intensive Cognitive Behavioural Therapy
arm group label: Weekly Cognitive Behavioural Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Josie FA Millar
role: Principal Investigator
affiliation: University of Bath
last name: Paul M Salkovskis
role: Study Director
affiliation: University of Bath
facility: 
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Bath
investigator full name: Josie Millar
investigator title: Lecturer & Clinical Psychologist
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder