<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/NCT01694719</url>
  </required_header>
  <id_info>
    <org_study_id>2930</org_study_id>
    <nct_id>NCT01694719</nct_id>
  </id_info>
  <brief_title>Cognitive Control Training as an Adjunct to Behavioral Activation Therapy in the Treatment of Depression</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the potential effects of a cognitive training&#xD;
      program when combined with a particular form of psychotherapy (behavioral activation therapy)&#xD;
      for depression. Behavioral activation therapy targets changes in behavior as a method for&#xD;
      improving a depressed individual's thoughts, feelings, and overall quality of life. This&#xD;
      study is designed to test whether a computerized brain exercise called cognitive control&#xD;
      training can enhance the effects of a 5-session behavioral activation therapy program. CCT&#xD;
      has been shown to reduce depressive symptoms in two other studies, but it has not yet been&#xD;
      combined with behavioral activation therapy. The investigators hypothesize that individuals&#xD;
      assigned to the behavioral activation plus cognitive control training condition will&#xD;
      demonstrate reduced depressive symptoms from pre to post treatment compared with those&#xD;
      assigned to the behavioral activation plus computerized control condition. The investigators&#xD;
      hypothesize that these gains will be maintained at one-month follow up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">October 2013</completion_date>
  <primary_completion_date type="Anticipated">October 2013</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Beck Depression Inventory</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Montgomery Asberg Depression Rating Scale</measure>
  </secondary_outcome>
  <other_outcome>
    <measure>Ruminative Response Scale</measure>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Behavioral Activation + Cognitive Control Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 5 sessions of behavioral activation therapy concurrent with 4 sessions of cognitive control training, a computerized intervention which targets cognitive control processes such as working memory and attention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Behavioral Activation Therapy plus Control Task</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive 5 sessions of behavioral activation therapy and 4 sessions of a non-active, computerized control task.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Behavioral Activation Treatment for Depression</intervention_name>
    <arm_group_label>Behavioral Activation + Cognitive Control Training</arm_group_label>
    <arm_group_label>Behavioral Activation Therapy plus Control Task</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Control Training</intervention_name>
    <arm_group_label>Behavioral Activation + Cognitive Control Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults ages 18-65&#xD;
&#xD;
          2. Primary psychiatric diagnosis of major depressive disorder&#xD;
&#xD;
          3. Ability to read and speak English sufficiently to complete study procedures&#xD;
&#xD;
          4. If taking antidepressant or anxiolytic medication, participants must be taking a&#xD;
             stabilized dose for a minimum period of at least 8 weeks prior to entry into the study&#xD;
&#xD;
          5. Willingness and ability to comply with the requirements of the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lifetime history of bipolar disorder or psychotic disorder&#xD;
&#xD;
          2. Neurological disorder such as Parkinson's disease or traumatic brain injury&#xD;
&#xD;
          3. Alcohol or substance dependence within the past 6 months&#xD;
&#xD;
          4. Substantial suicide risk&#xD;
&#xD;
          5. Concurrent psychotherapy initiated within 2 months of baseline, or ongoing&#xD;
             psychotherapy of any duration directed specifically toward treatment of the depression&#xD;
             other than general supportive therapy&#xD;
&#xD;
          6. Current use of antipsychotics, stimulants, or modafinil&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Samantha J Moshier, M.A.</last_name>
    <phone>617-358-4311</phone>
    <email>smoshier@bu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael W Otto, Ph.D.</last_name>
    <phone>617-353-9610</phone>
    <email>mwotto@bu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston University - Translational Research Program</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samantha Moshier, M.A.</last_name>
      <phone>617-358-4311</phone>
      <email>smoshier@bu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>September 26, 2012</last_update_submitted>
  <last_update_submitted_qc>September 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University</investigator_affiliation>
    <investigator_full_name>Samantha Moshier, M.A.</investigator_full_name>
    <investigator_title>Doctoral Candidate in Psychology</investigator_title>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Major Depressive Disorder</keyword>
  <keyword>Behavioral Activation</keyword>
  <keyword>Cognitive Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>July 31, 2016</submitted>
    <returned>September 20, 2016</returned>
  </pending_results>
  <!-- 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/NCT01694719
org study id: 2930
nct id: NCT01694719
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the potential effects of a cognitive training
      program when combined with a particular form of psychotherapy (behavioral activation therapy)
      for depression. Behavioral activation therapy targets changes in behavior as a method for
      improving a depressed individual's thoughts, feelings, and overall quality of life. This
      study is designed to test whether a computerized brain exercise called cognitive control
      training can enhance the effects of a 5-session behavioral activation therapy program. CCT
      has been shown to reduce depressive symptoms in two other studies, but it has not yet been
      combined with behavioral activation therapy. The investigators hypothesize that individuals
      assigned to the behavioral activation plus cognitive control training condition will
      demonstrate reduced depressive symptoms from pre to post treatment compared with those
      assigned to the behavioral activation plus computerized control condition. The investigators
      hypothesize that these gains will be maintained at one-month follow up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Beck Depression Inventory
measure: Montgomery Asberg Depression Rating Scale
measure: Ruminative Response Scale
arm group label: Behavioral Activation + Cognitive Control Training
arm group type: Experimental
description: Participants will receive 5 sessions of behavioral activation therapy concurrent with 4 sessions of cognitive control training, a computerized intervention which targets cognitive control processes such as working memory and attention.
arm group label: Behavioral Activation Therapy plus Control Task
arm group type: Active Comparator
description: Participants will receive 5 sessions of behavioral activation therapy and 4 sessions of a non-active, computerized control task.
intervention type: Behavioral
intervention name: Brief Behavioral Activation Treatment for Depression
arm group label: Behavioral Activation + Cognitive Control Training
arm group label: Behavioral Activation Therapy plus Control Task
intervention type: Behavioral
intervention name: Cognitive Control Training
arm group label: Behavioral Activation + Cognitive Control Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Samantha J Moshier, M.A.
phone: 617-358-4311
email: smoshier@bu.edu
last name: Michael W Otto, Ph.D.
phone: 617-353-9610
email: mwotto@bu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University
investigator full name: Samantha Moshier, M.A.
investigator title: Doctoral Candidate in Psychology
mesh term: Depression
mesh term: Depressive Disorder
submitted: July 31, 2016
returned: September 20, 2016