<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/NCT03799419</url>
  </required_header>
  <id_info>
    <org_study_id>2017P002864</org_study_id>
    <nct_id>NCT03799419</nct_id>
  </id_info>
  <brief_title>Cognitive Bias Modification for OCD</brief_title>
  <official_title>Cognitive Bias Modification as an Adjunctive Treatment for Treatment-Refractory OCD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mclean Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mclean Hospital</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>
      This study will conduct the development and preliminary evaluation of Cognitive Bias&#xD;
      Modification for Interpretation (CBM-I) and Approach Avoidance Training (AAT) as&#xD;
      augmentations to treatment as usual for OCD and related disorders. CBM-I refers to&#xD;
      computerized interventions designed to directly manipulate interpretation bias through&#xD;
      repeated practice on a training task, thereby inducing cognitive changes in a relatively&#xD;
      automatic or implicit manner. In AAT, automatic approach tendencies toward feared stimuli are&#xD;
      re-trained. Specifically, this study will examine the feasibility, acceptability, and&#xD;
      clinical outcomes associated with CBM-I and AAT.&#xD;
&#xD;
      Adults with obsessive compulsive disorder (OCD) and related disorders will be recruited from&#xD;
      a treatment program for these disorders and participants will be randomly assigned to either&#xD;
      receive: 1) eight sessions of CBM-I or eight sessions of psychoeducation as a control&#xD;
      condition, or 2) AAT or eight sessions of an inactive (sham) version of the AAT training.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">September 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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Average Score on Obsessive Beliefs Questionnaire</measure>
    <time_frame>Weeks 0, 2, 4, and 8</time_frame>
    <description>Measure of interpretation biases, specifically: Inflated Responsibility/Overestimation of Threat, Perfectionism/Intolerance of Uncertainty, and Importance/Control of Thoughts. 44-item self-report measure, items scored 1-7 and summed; greater scores indicate greater severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Average Score on Yale-Brown Obsessive Compulsive Scale</measure>
    <time_frame>Weeks 0, 4, and 8</time_frame>
    <description>Interviewer-rated measure of OCD symptoms. It is 19 items, with only items 1-10 scored (from 0-4). Total scores range from 0-40, with higher scores reflecting greater severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Columbia-Suicide Severity Rating Scale</measure>
    <time_frame>Weeks 0, 4, and 8</time_frame>
    <description>An interviewer-rated assessment of retrospective suicidality as well as recent suicidal ideation and behavior. Minimum total score 0, maximum total score 5, higher total scores indicate more suicidal ideation and/or behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Suicide Implicit Association Test</measure>
    <time_frame>Weeks 0, 2, and 4</time_frame>
    <description>Computerized task which assesses implicit thoughts about self-injury, death, and suicide.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity.</measure>
    <time_frame>Weeks 0, 1, 2, 3, and 4</time_frame>
    <description>Self-report measure of suicidality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Credibility/Expectancy Questionnaire</measure>
    <time_frame>Week 0</time_frame>
    <description>Measure of treatment expectancy and rationale credibility in our study. The items are rated on 9-point scales, with a total score range of 3 to 27. Greater scores indicate greater expectations and perceptions of treatment credibility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exit Interview</measure>
    <time_frame>Week 4</time_frame>
    <description>This interview will be conducted by a member of the study staff to obtain participant feedback on satisfaction and how the intervention might be improved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Behavioral Approach Test</measure>
    <time_frame>Weeks 0, 2, and 4</time_frame>
    <description>Behavioral Approach Test (BAT) will be administered as a measure of OCD-related avoidance, based on previously validated procedures (Cougle et al., 2007; Amir, Kuckertz, &amp; Najmi, 2013). Participants rate peak anxiety 0-100 for each step of approaching feared stimuli.&#xD;
Three different types of BAT will be implemented in order to measure avoidance with multiple types of contaminants, each with six steps on a hierarchy to be completed sequentially, providing a rating of anxiety 0-100 for each step.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales</measure>
    <time_frame>Weeks 0, 2, 4, and 8</time_frame>
    <description>24-item measure of behavioral approach and behavioral avoidance, rated 1-4 and summed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dimensional Obsessive-Compulsive Scale</measure>
    <time_frame>Weeks 0, 2, 4, and 8</time_frame>
    <description>(DOCS; Abramowitz et al., 2010) participants with contamination fears will be identified by their DOCS contamination subscale score; the DOCS is part of the admission measures in the OCD Institute's main study protocol. Additionally, we will examine these scores as an outcome measure for contamination-related obsessions and compulsions. It includes 20 items and is rated 0-4.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <condition>Obsessive-compulsive Disorders and Symptoms</condition>
  <arm_group>
    <arm_group_label>Cognitive bias modification with treatment as usual</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting interpretation bias</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation with treatment as usual</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants in this group will receive usual treatment in the program and 8 sessions of psychoeducation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Approach avoidance training with treatment as usual</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting automatic approach tendencies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inactive sham approach avoidance training</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants in this group will receive usual treatment in the program and 8 sessions of a sham approach avoidance training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive bias modification for interpretation bias</intervention_name>
    <description>Eight sessions of scenario-based CBM-I training for OCD will be administered, based on the widely-used paradigm of ambiguous scenario training developed by Mathews and Mackintosh (2000), in which participants are presented with scenarios that are ambiguous in whether or not they are threatening. Participants will complete a computer task consisting of a series of written scenarios designed to improve interpretation and attributional biases; these scenarios conclude with word fragments, which participants must fill in to resolve the ambiguity.</description>
    <arm_group_label>Cognitive bias modification with treatment as usual</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducation</intervention_name>
    <description>Eight sessions of psychoeducation will be administered, which will describe symptoms of anxiety, the nature of biased thinking in anxiety, and summarize common psychosocial as well as pharmacological treatments for anxiety. The sessions will provide relevant information but will not provide training in changing thinking styles.</description>
    <arm_group_label>Psychoeducation with treatment as usual</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Approach avoidance training</intervention_name>
    <description>Eight sessions of this computerized training program will be used to train approach tendencies, following previously validated procedures (Najmi, Kuckertz, &amp; Amir, 2010). During the training program, participants will view a series of these images and be prompted to push or pull a joystick according to prompts on the screen, instead of the content of the picture. Avoidance will be stimulated through both pushing away (images on the screen will decrease in size upon the joystick being pushed), and approach will be stimulated through pulling towards pictures (images will increase in size to simulate approach).</description>
    <arm_group_label>Approach avoidance training with treatment as usual</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Inactive sham approach avoidance training</intervention_name>
    <description>Eight sessions of the approach avoidance training will be administered, however the percentage of push vs pull trials will be altered in this sham version of the training.</description>
    <arm_group_label>Inactive sham approach avoidance training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently receiving treatment at the McLean Hospital OCD Institute&#xD;
&#xD;
          -  For CBM-I condition only: report a score of at least 131 on the Obsessive Beliefs&#xD;
             Questionnaire-44 upon admission to the OCD Institute&#xD;
&#xD;
          -  For AAT condition only: endorse score of at least 7 on the DOCS subscale #1&#xD;
             (contamination subscale) upon admission to the OCD Institute&#xD;
&#xD;
          -  Able to complete a computer task for 20 minutes&#xD;
&#xD;
          -  Consent to main OCD Institute study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently undergoing electroconvulsive therapy (ECT)&#xD;
&#xD;
          -  Current symptoms of acute mania or psychosis&#xD;
&#xD;
          -  A reported diagnosis at admission of a psychotic disorder&#xD;
&#xD;
          -  History of traumatic brain injury&#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_contact>
    <last_name>Martha Falkenstein</last_name>
    <phone>617-855-4424</phone>
    <email>mfalkenstein@mclean.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>McLean Hospital</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Martha Falkenstein</last_name>
      <phone>617-855-4424</phone>
      <email>mfalkenstein@mclean.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mclean Hospital</investigator_affiliation>
    <investigator_full_name>Martha J Falkenstein</investigator_full_name>
    <investigator_title>Staff Psychologist</investigator_title>
  </responsible_party>
  <keyword>cognitive bias modification</keyword>
  <keyword>interpretation bias</keyword>
  <keyword>approach avoidance</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/NCT03799419
org study id: 2017P002864
nct id: NCT03799419
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will conduct the development and preliminary evaluation of Cognitive Bias
      Modification for Interpretation (CBM-I) and Approach Avoidance Training (AAT) as
      augmentations to treatment as usual for OCD and related disorders. CBM-I refers to
      computerized interventions designed to directly manipulate interpretation bias through
      repeated practice on a training task, thereby inducing cognitive changes in a relatively
      automatic or implicit manner. In AAT, automatic approach tendencies toward feared stimuli are
      re-trained. Specifically, this study will examine the feasibility, acceptability, and
      clinical outcomes associated with CBM-I and AAT.

      Adults with obsessive compulsive disorder (OCD) and related disorders will be recruited from
      a treatment program for these disorders and participants will be randomly assigned to either
      receive: 1) eight sessions of CBM-I or eight sessions of psychoeducation as a control
      condition, or 2) AAT or eight sessions of an inactive (sham) version of the AAT training.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Average Score on Obsessive Beliefs Questionnaire
time frame: Weeks 0, 2, 4, and 8
description: Measure of interpretation biases, specifically: Inflated Responsibility/Overestimation of Threat, Perfectionism/Intolerance of Uncertainty, and Importance/Control of Thoughts. 44-item self-report measure, items scored 1-7 and summed; greater scores indicate greater severity.
measure: Change in Average Score on Yale-Brown Obsessive Compulsive Scale
time frame: Weeks 0, 4, and 8
description: Interviewer-rated measure of OCD symptoms. It is 19 items, with only items 1-10 scored (from 0-4). Total scores range from 0-40, with higher scores reflecting greater severity.
measure: Change in Columbia-Suicide Severity Rating Scale
time frame: Weeks 0, 4, and 8
description: An interviewer-rated assessment of retrospective suicidality as well as recent suicidal ideation and behavior. Minimum total score 0, maximum total score 5, higher total scores indicate more suicidal ideation and/or behavior.
measure: Change in Suicide Implicit Association Test
time frame: Weeks 0, 2, and 4
description: Computerized task which assesses implicit thoughts about self-injury, death, and suicide.
measure: Change in Average Score on Depressive Symptom Index Suicidality Subscale. There are 4 items scored from 0-3 with greater numbers indicating greater severity.
time frame: Weeks 0, 1, 2, 3, and 4
description: Self-report measure of suicidality
measure: Credibility/Expectancy Questionnaire
time frame: Week 0
description: Measure of treatment expectancy and rationale credibility in our study. The items are rated on 9-point scales, with a total score range of 3 to 27. Greater scores indicate greater expectations and perceptions of treatment credibility.
measure: Exit Interview
time frame: Week 4
description: This interview will be conducted by a member of the study staff to obtain participant feedback on satisfaction and how the intervention might be improved.
measure: Change in Behavioral Approach Test
time frame: Weeks 0, 2, and 4
description: Behavioral Approach Test (BAT) will be administered as a measure of OCD-related avoidance, based on previously validated procedures (Cougle et al., 2007; Amir, Kuckertz, & Najmi, 2013). Participants rate peak anxiety 0-100 for each step of approaching feared stimuli.
Three different types of BAT will be implemented in order to measure avoidance with multiple types of contaminants, each with six steps on a hierarchy to be completed sequentially, providing a rating of anxiety 0-100 for each step.
measure: Change in Average Score on Behavioral Inhibition/Behavioral Activation Scales
time frame: Weeks 0, 2, 4, and 8
description: 24-item measure of behavioral approach and behavioral avoidance, rated 1-4 and summed.
measure: Dimensional Obsessive-Compulsive Scale
time frame: Weeks 0, 2, 4, and 8
description: (DOCS; Abramowitz et al., 2010) participants with contamination fears will be identified by their DOCS contamination subscale score; the DOCS is part of the admission measures in the OCD Institute's main study protocol. Additionally, we will examine these scores as an outcome measure for contamination-related obsessions and compulsions. It includes 20 items and is rated 0-4.
arm group label: Cognitive bias modification with treatment as usual
arm group type: Experimental
description: Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting interpretation bias
arm group label: Psychoeducation with treatment as usual
arm group type: Sham Comparator
description: Participants in this group will receive usual treatment in the program and 8 sessions of psychoeducation
arm group label: Approach avoidance training with treatment as usual
arm group type: Experimental
description: Participants in this group will receive usual treatment in the program and 8 sessions of a computerized cognitive training targeting automatic approach tendencies
arm group label: Inactive sham approach avoidance training
arm group type: Sham Comparator
description: Participants in this group will receive usual treatment in the program and 8 sessions of a sham approach avoidance training
intervention type: Behavioral
intervention name: Cognitive bias modification for interpretation bias
description: Eight sessions of scenario-based CBM-I training for OCD will be administered, based on the widely-used paradigm of ambiguous scenario training developed by Mathews and Mackintosh (2000), in which participants are presented with scenarios that are ambiguous in whether or not they are threatening. Participants will complete a computer task consisting of a series of written scenarios designed to improve interpretation and attributional biases; these scenarios conclude with word fragments, which participants must fill in to resolve the ambiguity.
arm group label: Cognitive bias modification with treatment as usual
intervention type: Behavioral
intervention name: Psychoeducation
description: Eight sessions of psychoeducation will be administered, which will describe symptoms of anxiety, the nature of biased thinking in anxiety, and summarize common psychosocial as well as pharmacological treatments for anxiety. The sessions will provide relevant information but will not provide training in changing thinking styles.
arm group label: Psychoeducation with treatment as usual
intervention type: Behavioral
intervention name: Approach avoidance training
description: Eight sessions of this computerized training program will be used to train approach tendencies, following previously validated procedures (Najmi, Kuckertz, & Amir, 2010). During the training program, participants will view a series of these images and be prompted to push or pull a joystick according to prompts on the screen, instead of the content of the picture. Avoidance will be stimulated through both pushing away (images on the screen will decrease in size upon the joystick being pushed), and approach will be stimulated through pulling towards pictures (images will increase in size to simulate approach).
arm group label: Approach avoidance training with treatment as usual
intervention type: Behavioral
intervention name: Inactive sham approach avoidance training
description: Eight sessions of the approach avoidance training will be administered, however the percentage of push vs pull trials will be altered in this sham version of the training.
arm group label: Inactive sham approach avoidance training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martha Falkenstein
phone: 617-855-4424
email: mfalkenstein@mclean.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mclean Hospital
investigator full name: Martha J Falkenstein
investigator title: Staff Psychologist
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder