<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/NCT02256566</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 14-0994</org_study_id>
    <nct_id>NCT02256566</nct_id>
  </id_info>
  <brief_title>Cognitive Training for Mood and Anxiety Disorders</brief_title>
  <official_title>Cognitive Training for Mood and Anxiety Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effects of a computerized cognitive training&#xD;
      program (an attention and memory exercise performed on a computer) on thinking and memory in&#xD;
      individuals with mood and anxiety disorders, and to begin to test whether this training&#xD;
      affects symptoms of depression or anxiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this research protocol is to collect feasibility and pilot data&#xD;
      investigating the efficacy of a computerized cognitive training paradigm. The training&#xD;
      paradigm aims to enhance cognitive control for emotional information-processing and reduce&#xD;
      the negative affective biases observed among those experiencing mood and anxiety symptoms and&#xD;
      disorders. This protocol will also investigate whether improvements in cognitive control and&#xD;
      affective bias are associated with changes in mood and anxiety symptoms. Participants will&#xD;
      undergo 6 weeks of cognitive training sessions, with three sessions per week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 20, 2016</completion_date>
  <primary_completion_date type="Actual">April 20, 2016</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of completers to measure feasibility</measure>
    <time_frame>week 6</time_frame>
    <description>comparing the proportion of completers (15-18 sessions) between the in-person participants and the participants completing the exercise on their own computers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Depression Symptom Severity</measure>
    <time_frame>baseline and week 6</time_frame>
    <description>Depression symptom severity comparison at week 6 to baseline as measured by the Hamilton Depression Rating Scale (Ham-D) and Quick Inventory of Depressive Symptoms (QIDS-C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety Symptom Severity</measure>
    <time_frame>baseline and week 6</time_frame>
    <description>Anxiety symptom severity comparison at week 6 to baseline as measured by the Hamilton Anxiety Rating Scale (Ham-A) and Treatment Outcome PTSD Scale (TOP-8)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Negative Affective Bias</measure>
    <time_frame>baseline and week 6</time_frame>
    <description>Negative affective bias comparison at week 6 to baseline as measured by the Self-referential Information Processing Task, Affective Go/No-Go, Emotional Stroop, Emotion Faces Recognition Task, Cognitive Style Questionnaire, Ruminative Responses Scale, and Attention Bias Variability Task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Neurocognition</measure>
    <time_frame>baseline and week 6</time_frame>
    <description>neurocognition comparison at week 6 to baseline using Digit Span, Letter-Number Sequencing, Hopkins Verbal Learning Test, and Intra-Extra Dimensional Set-Shifting</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Major Depressive Disorder</condition>
  <condition>Depression</condition>
  <condition>Bipolar Disorder</condition>
  <condition>Post-traumatic Stress Disorder</condition>
  <condition>Generalized Anxiety Disorder</condition>
  <condition>Social Phobia</condition>
  <arm_group>
    <arm_group_label>emotional memory training exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>study training exercise - Emotional Faces Memory Task (EFMT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>memory training exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>an active control exercise (CT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>emotional memory training exercise</intervention_name>
    <arm_group_label>emotional memory training exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>memory training exercise</intervention_name>
    <arm_group_label>memory training exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary, current Axis I diagnosis of a mood disorder (e.g., major depressive disorder&#xD;
             (MDD); bipolar disorder, currently depressed) or anxiety disorder (PTSD; Generalized&#xD;
             Anxiety Disorder (GAD); Social Phobia) according to DSM-IV criteria and SCID-IV&#xD;
             diagnosis OR must be free of any psychiatric condition (for the healthy volunteer&#xD;
             group)&#xD;
&#xD;
          -  Age 18-80&#xD;
&#xD;
          -  Participants must have a level of understanding of the English language sufficient to&#xD;
             agree to all tests and examinations required by the study and must be able to&#xD;
             participate fully in the informed consent process&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of drug or alcohol abuse or dependence (DSM-IV criteria) within the previous&#xD;
             6 months&#xD;
&#xD;
          -  Visual impairment that would affect the ability to observe the computerized exercises&#xD;
&#xD;
          -  Motor impairment that would affect the ability to provide a response by quickly&#xD;
             pressing a button&#xD;
&#xD;
          -  Patients with mood congruent or mood incongruent psychotic features&#xD;
&#xD;
          -  Primary, current Axis I diagnosis other than MDD, Bipolar Disorder (currently&#xD;
             depressed), PTSD, GAD or Social Phobia&#xD;
&#xD;
          -  The presence of axis II personality disorder psychopathology that, in the opinion of&#xD;
             the investigator, will interfere with study participation&#xD;
&#xD;
          -  Acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6&#xD;
             months of screening)&#xD;
&#xD;
          -  Pregnancy in women. Pregnant women are excluded from the study because research has&#xD;
             shown that hormonal changes that occur during pregnancy can mimic and/or influence&#xD;
             symptoms of depression. Including patterns of mood and cognition. These mood and&#xD;
             cognitive changes could mask the effect of the cognitive training in this study, so&#xD;
             pregnant women will be excluded for that reason. A urine pregnancy test will be&#xD;
             administered at screening&#xD;
&#xD;
          -  Enrolled participants can be currently taking standard antidepressant or mood&#xD;
             stabilizer medication regimens, or benzodiazepine treatment for sleep as needed but&#xD;
             not exceeding 3 nights per week. Medication regimens must be stable at the time of&#xD;
             study enrollment (i.e., no medication has been started within 8 weeks, stopped within&#xD;
             6 weeks or titrated up or down within 4 weeks of study entry). No medications will be&#xD;
             started or discontinued for the purpose of enrollment into the study&#xD;
&#xD;
          -  Subjects must exhibit no or only moderate alcohol use during study participation.&#xD;
             Subjects with current excessive use of alcohol (&gt; 8 ounces/day) or participants&#xD;
             abusing substances will be ineligible for participation, as such drug use could&#xD;
             confound the results. A urine toxicology test will be administered at screening to&#xD;
             test for drugs of abuse&#xD;
&#xD;
          -  Participants exhibiting depression symptoms in the severe range (Ham-D &gt; 27) will be&#xD;
             excluded from participation as an investigational study such as this may not be&#xD;
             suitable&#xD;
&#xD;
          -  Participants exhibiting chronic MDD episodes (defined as a current episode lasting 5+&#xD;
             years) will be excluded from participation as an investigational study such as this&#xD;
             may not be suitable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Iacoviello, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>July 19, 2017</last_update_submitted>
  <last_update_submitted_qc>July 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cognitive training</keyword>
  <keyword>depression</keyword>
  <keyword>bipolar depression</keyword>
  <keyword>anxiety</keyword>
  <keyword>ptsd</keyword>
  <keyword>generalized anxiety</keyword>
  <keyword>social phobia</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>
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    <mesh_term>Phobia, Social</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/NCT02256566
org study id: GCO 14-0994
nct id: NCT02256566
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the effects of a computerized cognitive training
      program (an attention and memory exercise performed on a computer) on thinking and memory in
      individuals with mood and anxiety disorders, and to begin to test whether this training
      affects symptoms of depression or anxiety.
The objective of this research protocol is to collect feasibility and pilot data
      investigating the efficacy of a computerized cognitive training paradigm. The training
      paradigm aims to enhance cognitive control for emotional information-processing and reduce
      the negative affective biases observed among those experiencing mood and anxiety symptoms and
      disorders. This protocol will also investigate whether improvements in cognitive control and
      affective bias are associated with changes in mood and anxiety symptoms. Participants will
      undergo 6 weeks of cognitive training sessions, with three sessions per week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Proportion of completers to measure feasibility
time frame: week 6
description: comparing the proportion of completers (15-18 sessions) between the in-person participants and the participants completing the exercise on their own computers
measure: Change in Depression Symptom Severity
time frame: baseline and week 6
description: Depression symptom severity comparison at week 6 to baseline as measured by the Hamilton Depression Rating Scale (Ham-D) and Quick Inventory of Depressive Symptoms (QIDS-C)
measure: Change in Anxiety Symptom Severity
time frame: baseline and week 6
description: Anxiety symptom severity comparison at week 6 to baseline as measured by the Hamilton Anxiety Rating Scale (Ham-A) and Treatment Outcome PTSD Scale (TOP-8)
measure: Change in Negative Affective Bias
time frame: baseline and week 6
description: Negative affective bias comparison at week 6 to baseline as measured by the Self-referential Information Processing Task, Affective Go/No-Go, Emotional Stroop, Emotion Faces Recognition Task, Cognitive Style Questionnaire, Ruminative Responses Scale, and Attention Bias Variability Task
measure: Change in Neurocognition
time frame: baseline and week 6
description: neurocognition comparison at week 6 to baseline using Digit Span, Letter-Number Sequencing, Hopkins Verbal Learning Test, and Intra-Extra Dimensional Set-Shifting
arm group label: emotional memory training exercise
arm group type: Experimental
description: study training exercise - Emotional Faces Memory Task (EFMT)
arm group label: memory training exercise
arm group type: Active Comparator
description: an active control exercise (CT)
intervention type: Behavioral
intervention name: emotional memory training exercise
arm group label: emotional memory training exercise
intervention type: Behavioral
intervention name: memory training exercise
arm group label: memory training exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Brian Iacoviello, PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
mesh term: Depressive Disorder, Major
mesh term: Stress Disorders, Traumatic
mesh term: Bipolar Disorder
mesh term: Stress Disorders, Post-Traumatic
mesh term: Phobia, Social