<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/NCT04414215</url>
  </required_header>
  <id_info>
    <org_study_id>00001377</org_study_id>
    <nct_id>NCT04414215</nct_id>
  </id_info>
  <brief_title>Cognitive Training for Emotion Regulation in Psychotic Disorders</brief_title>
  <official_title>Cognitive Training for Emotion Regulation in Psychotic Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Georgia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Georgia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study examines the efficacy of a cognitive training intervention for improving&#xD;
      emotion regulation in psychotic disorders. it is hypothesized that the cognitive training&#xD;
      program will enhance prefrontal activation, leading to enhanced emotion regulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Psychotic disorders are serious and debilitating mental illnesses that incur substantial&#xD;
      suffering for patients and present major challenges to our health care system. Difficulties&#xD;
      with emotion regulation (i.e., the ability to control the emotion response using strategies)&#xD;
      significantly predict the development and maintenance of psychotic symptoms and poor&#xD;
      community-based functional outcomes. Recent neuroimaging research indicates that&#xD;
      hypofrontality may underlie these deficits. Unfortunately, there is no accepted technique for&#xD;
      remediating these emotion regulation abnormalities in psychotic disorders. Recent advances&#xD;
      from the field of cognitive neuroscience provide hope for a resolution to this critical unmet&#xD;
      need in psychotic disorder therapeutics, demonstrating that brief computerized cognitive&#xD;
      training interventions are capable of improving emotion regulation ability by targeting&#xD;
      neural activation in the prefrontal cortex. The goal of the proposed project is to determine&#xD;
      whether an emotional working memory cognitive training program is effective for remediating&#xD;
      emotion regulation abnormalities and associated clinical outcomes in people with psychotic&#xD;
      disorders. Outpatients with psychotic disorders will be randomly assigned to either an&#xD;
      emotional working memory training (n = 35) or placebo (P: n = 35) cognitive training control&#xD;
      intervention delivered via an app on a smart phone for 30 days. The primary aim is to&#xD;
      determine whether the emotional working memory intervention successfully engages the target&#xD;
      mechanism and enhances prefrontal activation on a non-trained emotion regulation transfer&#xD;
      task beyond a pre-specified effect size criterion. Results will also be used to determine the&#xD;
      treatment duration (15 vs. 30 days) that most effectively and efficiently improves the&#xD;
      target.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>
    <intervention_model_description>A double blind design will be used, where participants will be randomly assigned to placebo or emotional working memory training</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prefrontal blood oxygen level dependent activation in the prefrontal cortex</measure>
    <time_frame>Change from baseline to 15 days or 30 days</time_frame>
    <description>blood oxygen level dependent change in the prefrontal cortex as measured using functional magnetic resonance imaging. This will be calculated as a change from baseline to follow-up on the contrast score (unpleasant passive viewing condition - reappraisal) on the emotion regulation reappraisal task</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizo Affective Disorder</condition>
  <arm_group>
    <arm_group_label>Cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Emotional working memory training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo training</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo working memory training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emotional working memory training</intervention_name>
    <description>Participants will complete an emotional working memory n-back training program that progressively increases difficulty and has been shown to enhance prefrontal activity in a non-psychiatric sample</description>
    <arm_group_label>Cognitive training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo working memory training</intervention_name>
    <description>Working memory training that does not involve emotional stimuli using an N-back training program</description>
    <arm_group_label>Placebo training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnostic and statistical manual fifth edition diagnosis of schizophrenia or&#xD;
             schizoaffective disorder&#xD;
&#xD;
          -  18-60 years old&#xD;
&#xD;
          -  speaks English&#xD;
&#xD;
          -  premorbid intelligence quotient &gt; 70&#xD;
&#xD;
          -  clinically stable as indicated by no antipsychotic medication changes in the last&#xD;
             month or if on depot, no change in the past 2 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of intellectual disability or neurological disorder&#xD;
&#xD;
          -  history of traumatic brain injury with loss of consciousness &gt; 10 minutes or&#xD;
             behavioral sequelae&#xD;
&#xD;
          -  substance use disorder within the last 6 months (other than nicotine)&#xD;
&#xD;
          -  4) endorsement of MRI exclusion factors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gregory P Strauss, PhD</last_name>
    <phone>706-542-0307</phone>
    <email>gstrauss@uga.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Georgia</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30602</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gregory P Strauss, PhD</last_name>
      <phone>706-542-0307</phone>
      <email>gstrauss@uga.edu</email>
    </contact>
    <investigator>
      <last_name>Gregory P Strauss, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lawrence Sweet, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dean Sabatinelli, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Georgia</investigator_affiliation>
    <investigator_full_name>Gregory Paul Strauss</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be uploaded to the National Institute of Mental Health Data Archive</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>1 year after study completion for 1 year</ipd_time_frame>
    <ipd_access_criteria>The National Institute of Mental Health Data Archive request</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04414215
org study id: 00001377
nct id: NCT04414215
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study examines the efficacy of a cognitive training intervention for improving
      emotion regulation in psychotic disorders. it is hypothesized that the cognitive training
      program will enhance prefrontal activation, leading to enhanced emotion regulation.
Psychotic disorders are serious and debilitating mental illnesses that incur substantial
      suffering for patients and present major challenges to our health care system. Difficulties
      with emotion regulation (i.e., the ability to control the emotion response using strategies)
      significantly predict the development and maintenance of psychotic symptoms and poor
      community-based functional outcomes. Recent neuroimaging research indicates that
      hypofrontality may underlie these deficits. Unfortunately, there is no accepted technique for
      remediating these emotion regulation abnormalities in psychotic disorders. Recent advances
      from the field of cognitive neuroscience provide hope for a resolution to this critical unmet
      need in psychotic disorder therapeutics, demonstrating that brief computerized cognitive
      training interventions are capable of improving emotion regulation ability by targeting
      neural activation in the prefrontal cortex. The goal of the proposed project is to determine
      whether an emotional working memory cognitive training program is effective for remediating
      emotion regulation abnormalities and associated clinical outcomes in people with psychotic
      disorders. Outpatients with psychotic disorders will be randomly assigned to either an
      emotional working memory training (n = 35) or placebo (P: n = 35) cognitive training control
      intervention delivered via an app on a smart phone for 30 days. The primary aim is to
      determine whether the emotional working memory intervention successfully engages the target
      mechanism and enhances prefrontal activation on a non-trained emotion regulation transfer
      task beyond a pre-specified effect size criterion. Results will also be used to determine the
      treatment duration (15 vs. 30 days) that most effectively and efficiently improves the
      target.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A double blind design will be used, where participants will be randomly assigned to placebo or emotional working memory training
primary purpose: Treatment
masking: Single (Investigator)
measure: Prefrontal blood oxygen level dependent activation in the prefrontal cortex
time frame: Change from baseline to 15 days or 30 days
description: blood oxygen level dependent change in the prefrontal cortex as measured using functional magnetic resonance imaging. This will be calculated as a change from baseline to follow-up on the contrast score (unpleasant passive viewing condition - reappraisal) on the emotion regulation reappraisal task
arm group label: Cognitive training
arm group type: Experimental
description: Emotional working memory training
arm group label: Placebo training
arm group type: Placebo Comparator
description: Placebo working memory training
intervention type: Behavioral
intervention name: Emotional working memory training
description: Participants will complete an emotional working memory n-back training program that progressively increases difficulty and has been shown to enhance prefrontal activity in a non-psychiatric sample
arm group label: Cognitive training
intervention type: Behavioral
intervention name: Placebo working memory training
description: Working memory training that does not involve emotional stimuli using an N-back training program
arm group label: Placebo training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Gregory P Strauss, PhD
phone: 706-542-0307
email: gstrauss@uga.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Georgia
investigator full name: Gregory Paul Strauss
investigator title: Associate Professor
mesh term: Schizophrenia
mesh term: Mental Disorders
mesh term: Psychotic Disorders
mesh term: Mood Disorders
sharing ipd: Yes
ipd description: Data will be uploaded to the National Institute of Mental Health Data Archive
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: 1 year after study completion for 1 year
ipd access criteria: The National Institute of Mental Health Data Archive request