<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/NCT03241056</url>
  </required_header>
  <id_info>
    <org_study_id>H2017:142</org_study_id>
    <nct_id>NCT03241056</nct_id>
  </id_info>
  <brief_title>Cognitive Checking Intervention for Maladaptive Beliefs About Memory</brief_title>
  <official_title>Increasing Memory Confidence: A Novel Intervention for Obsessive-Compulsive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A small (N = 24) pilot study developed a new and brief cognitive-behavioural therapy (CBT)&#xD;
      module for checking symptoms (CBT-C) in obsessive-compulsive disorder (OCD). CBT-C targets&#xD;
      maladaptive beliefs about memory and results show that it is effective at significantly&#xD;
      decreasing checking symptoms as compared to a waitlist control. The objectives of the current&#xD;
      investigation are to further investigate CBT-C by (1) replicating the pilot results in a&#xD;
      larger sample; (2) using an active control condition (treatment as usual) as the comparison&#xD;
      condition (3) including a 6-month follow-up, and (4) determining whether the association&#xD;
      between maladaptive beliefs about memory at pre-treatment assessment are related to degree of&#xD;
      checking symptom reduction following CBT-C. The findings of the study will have theoretical&#xD;
      significance in adding to our understanding of the maladaptive belief domains relevant to the&#xD;
      development and maintenance of OCD and supporting the cognitive model of compulsive checking.&#xD;
      The relevant clinical significance is the further development of an intervention that could&#xD;
      improve outcomes in treatment of persons with OCD. The key practical outcome of the research&#xD;
      would be to add a stepped care offering to patients with OCD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding used up; recruitment slow.&#xD;
  </why_stopped>
  <start_date type="Actual">January 4, 2018</start_date>
  <completion_date type="Actual">July 28, 2023</completion_date>
  <primary_completion_date type="Actual">July 28, 2023</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>Vancouver Obsessional Compulsive Inventory - checking subscale (change)</measure>
    <time_frame>Change in checking symptoms from pre-treatment to post-treatment at 3 weeks later</time_frame>
    <description>This six-item subscale of a self-report questionnaire measure assesses severity of checking-related OCD symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average time spent checking per week (change)</measure>
    <time_frame>Change in average time spent checking from pre-treatment to post-treatment at 3 weeks later</time_frame>
    <description>Participants record their daily time spent checking in daily diary records while in the active phase of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vancouver Obsessional Compulsive Inventory - checking subscale</measure>
    <time_frame>Avarege time spent checking at 6-month follow-up</time_frame>
    <description>This six-item subscale of a self-report questionnaire measure assesses severity of checking-related OCD symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Beliefs about Memory Inventory (change)</measure>
    <time_frame>Change in beliefs about memory from pre-treatment to post-treatment at 3 weeks later</time_frame>
    <description>Self-report questionnaire that assesses extent participant believes they have a bad memory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beliefs about Memory Inventory</measure>
    <time_frame>Beliefs about memory at 6 month follow-up</time_frame>
    <description>Self-report questionnaire that assesses extent participant believes they have a bad memory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obsessive Beliefs Questionnaire (change)</measure>
    <time_frame>Change in obsessive beliefs from pre-treatment to post-treatment at 3 weeks later</time_frame>
    <description>Self-report questionnaire that assesses maladaptive belief domains known to be related to checking. The responsibility/threat subscale is of particular interest as it is known to be related to checking behaviour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obsessive Beliefs Questionnaire</measure>
    <time_frame>Obsessive beliefs at 6-month follow-up</time_frame>
    <description>Self-report questionnaire that assesses maladaptive belief domains known to be related to checking. The responsibility/threat subscale is of particular interest as it is known to be related to checking behaviour.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>CBT for Maladaptive Beliefs about Memory</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using cognitive-behavioural therapy principles, this therapy is intended to examine and change maladaptive beliefs about memory as they pertain to compulsive checking.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This is a control treatment, Treatment as Usual (TAU), which is what patients or community members would otherwise normally receive.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT for Maladaptive Beliefs about Memory</intervention_name>
    <description>The novel intervention is a manualized 2-session cognitive behavioural therapy. Agenda elements, including psycho-education, discussion prompts, and homework exercises are standardized across participants. In session 1, participants are taught about the cognitive theory of checking, the research support behind this theory, and how it may apply to their own checking behavior. A homework exercise is introduced and practiced to test out this theory. In session 2, the homework results are reviewed. Further education is shared on the nature of memory and the relationship to checking, and a discussion regarding how this applies to the participant's checking then takes place. A second homework exercise is introduced to test this theory.</description>
    <arm_group_label>CBT for Maladaptive Beliefs about Memory</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>Treatment as Usual (TAU) during patients' time on our waitlist in our clinic will depend on at what point they have been recruited. It may consist of a 2-session group psychoeducational intervention on anxiety, any medications prescribed by their referring physicians, and/or independent therapy/counseling they may be seeking on the side. TAU for community participants will include any treatments they are currently seeking. Information about participation in such interventions will be collected during the course of the study (at each assessment visit) in order to accurately characterize participants' TAU in the current study.</description>
    <arm_group_label>Treatment as Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult over the age of 18 living in the province of Manitoba, Canada.&#xD;
&#xD;
          -  Diagnosis of OCD with clinically significant levels of compulsive checking (i.e., able&#xD;
             to meet the diagnostic criteria for OCD according to the Diagnostic and Statistical&#xD;
             Manual of Mental Disorders, 5th Edition based solely on checking symptoms. Other OCD&#xD;
             symptoms may be present and checking does not need to be the primary symptom.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active psychosis&#xD;
&#xD;
          -  Active Mania&#xD;
&#xD;
          -  Presence of a substance use disorder that would interfere with participation in the&#xD;
             treatment&#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>St. Boniface Hospital</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R2H2A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Gillian Alcolado</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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/NCT03241056
org study id: H2017:142
nct id: NCT03241056
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A small (N = 24) pilot study developed a new and brief cognitive-behavioural therapy (CBT)
      module for checking symptoms (CBT-C) in obsessive-compulsive disorder (OCD). CBT-C targets
      maladaptive beliefs about memory and results show that it is effective at significantly
      decreasing checking symptoms as compared to a waitlist control. The objectives of the current
      investigation are to further investigate CBT-C by (1) replicating the pilot results in a
      larger sample; (2) using an active control condition (treatment as usual) as the comparison
      condition (3) including a 6-month follow-up, and (4) determining whether the association
      between maladaptive beliefs about memory at pre-treatment assessment are related to degree of
      checking symptom reduction following CBT-C. The findings of the study will have theoretical
      significance in adding to our understanding of the maladaptive belief domains relevant to the
      development and maintenance of OCD and supporting the cognitive model of compulsive checking.
      The relevant clinical significance is the further development of an intervention that could
      improve outcomes in treatment of persons with OCD. The key practical outcome of the research
      would be to add a stepped care offering to patients with OCD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Vancouver Obsessional Compulsive Inventory - checking subscale (change)
time frame: Change in checking symptoms from pre-treatment to post-treatment at 3 weeks later
description: This six-item subscale of a self-report questionnaire measure assesses severity of checking-related OCD symptoms.
measure: Average time spent checking per week (change)
time frame: Change in average time spent checking from pre-treatment to post-treatment at 3 weeks later
description: Participants record their daily time spent checking in daily diary records while in the active phase of the study.
measure: Vancouver Obsessional Compulsive Inventory - checking subscale
time frame: Avarege time spent checking at 6-month follow-up
description: This six-item subscale of a self-report questionnaire measure assesses severity of checking-related OCD symptoms.
measure: Beliefs about Memory Inventory (change)
time frame: Change in beliefs about memory from pre-treatment to post-treatment at 3 weeks later
description: Self-report questionnaire that assesses extent participant believes they have a bad memory.
measure: Beliefs about Memory Inventory
time frame: Beliefs about memory at 6 month follow-up
description: Self-report questionnaire that assesses extent participant believes they have a bad memory.
measure: Obsessive Beliefs Questionnaire (change)
time frame: Change in obsessive beliefs from pre-treatment to post-treatment at 3 weeks later
description: Self-report questionnaire that assesses maladaptive belief domains known to be related to checking. The responsibility/threat subscale is of particular interest as it is known to be related to checking behaviour.
measure: Obsessive Beliefs Questionnaire
time frame: Obsessive beliefs at 6-month follow-up
description: Self-report questionnaire that assesses maladaptive belief domains known to be related to checking. The responsibility/threat subscale is of particular interest as it is known to be related to checking behaviour.
arm group label: CBT for Maladaptive Beliefs about Memory
arm group type: Experimental
description: Using cognitive-behavioural therapy principles, this therapy is intended to examine and change maladaptive beliefs about memory as they pertain to compulsive checking.
arm group label: Treatment as Usual
arm group type: Active Comparator
description: This is a control treatment, Treatment as Usual (TAU), which is what patients or community members would otherwise normally receive.
intervention type: Behavioral
intervention name: CBT for Maladaptive Beliefs about Memory
description: The novel intervention is a manualized 2-session cognitive behavioural therapy. Agenda elements, including psycho-education, discussion prompts, and homework exercises are standardized across participants. In session 1, participants are taught about the cognitive theory of checking, the research support behind this theory, and how it may apply to their own checking behavior. A homework exercise is introduced and practiced to test out this theory. In session 2, the homework results are reviewed. Further education is shared on the nature of memory and the relationship to checking, and a discussion regarding how this applies to the participant's checking then takes place. A second homework exercise is introduced to test this theory.
arm group label: CBT for Maladaptive Beliefs about Memory
intervention type: Other
intervention name: Treatment as Usual
description: Treatment as Usual (TAU) during patients' time on our waitlist in our clinic will depend on at what point they have been recruited. It may consist of a 2-session group psychoeducational intervention on anxiety, any medications prescribed by their referring physicians, and/or independent therapy/counseling they may be seeking on the side. TAU for community participants will include any treatments they are currently seeking. Information about participation in such interventions will be collected during the course of the study (at each assessment visit) in order to accurately characterize participants' TAU in the current study.
arm group label: Treatment as Usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Gillian Alcolado
investigator title: Assistant Professor
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder