<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/NCT03829280</url>
  </required_header>
  <id_info>
    <org_study_id>HSC20180237H</org_study_id>
    <secondary_id>1R01MH117101-01</secondary_id>
    <nct_id>NCT03829280</nct_id>
  </id_info>
  <brief_title>Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)</brief_title>
  <acronym>CAT-EM</acronym>
  <official_title>Cognitive Adaption Training-Effectiveness in Real-world Settings and Mechanism of Action (CAT-EM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vanguard Research Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <oversight_info>
    <has_dmc>Yes</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 investigators propose a cluster randomized effectiveness trial comparing Cognitive&#xD;
      Adaptation Training (CAT; a psychosocial treatment using environmental supports such as&#xD;
      signs, alarms, pill containers, checklists, technology and the organization of belongings&#xD;
      established in a person's home or work environment to bypass the cognitive and motivational&#xD;
      difficulties associated with schizophrenia ) to existing community treatment (CT) for&#xD;
      individuals with schizophrenia in 8 community mental health centers across multiple states&#xD;
      including 400 participants. Mechanisms of action will be examined. Participants will be&#xD;
      assessed at baseline and 6 and 12 months on measures of functional and community outcome,&#xD;
      medication adherence, symptoms, habit formation and automaticity, cognition and motivation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Schizophrenia remains one of the most disabling conditions world-wide with an economic burden&#xD;
      that exceeded $155 billion dollars in fiscal year 2013 alone. Despite existing medication and&#xD;
      community treatment, many individuals with this diagnosis continue to have poor outcomes and&#xD;
      struggle toward recovery. CAT is a psychosocial treatment using environmental supports such&#xD;
      as signs, alarms, pill containers, checklists, technology and the organization of belongings&#xD;
      established in a person's home or work environment to bypass the cognitive and motivational&#xD;
      difficulties associated with schizophrenia, and support habits for functional behavior to&#xD;
      promote recovery. In a series of efficacy studies, CAT improved social and occupational&#xD;
      functioning, symptoms, and adherence to medication, and reduced rates of readmission. The&#xD;
      investigators propose a cluster randomized effectiveness trial comparing Cognitive Adaptation&#xD;
      Training (CAT) to existing community treatment (CT) for individuals with schizophrenia in 8&#xD;
      community mental health centers across multiple states including 400 participants. This would&#xD;
      be the first large-scale effectiveness study of CAT for improving functional outcomes for&#xD;
      those with schizophrenia seen in community mental health centers (CMHCs) where the majority&#xD;
      of those with schizophrenia are followed for outpatient care and to study the purported&#xD;
      mechanisms of action based on an integrated theoretical model. Participants will be assessed&#xD;
      at baseline and 6 and 12 months on measures of functional and community outcome, medication&#xD;
      adherence, symptoms, habit formation and automaticity, cognition and motivation. CAT&#xD;
      treatment will be weekly for 6 months, biweekly for 3 months and monthly for the remainder of&#xD;
      the trial. Purported mechanisms of action for CAT including bypassing impairments in&#xD;
      cognitive function to improve functional outcome and bypassing motivational impairments to&#xD;
      create automatic habits to improve functional outcome will be examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 4, 2019</start_date>
  <completion_date type="Anticipated">April 2025</completion_date>
  <primary_completion_date type="Anticipated">April 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>
    <intervention_model_description>Cluster Randomized clinical trial conducted at 8 community mental health outpatient treatment sites across the country</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Raters assessing clinical outcome variables are centralized raters who are blind to treatment group as well as study design and aims.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Social and Occupational Functioning Scale Scores</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>A rating from 0-100 reflecting global level of Social and Occupational functioning; Higher scores indicate better functioning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Daily activity</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>Negative Symptom Assessment item 14 assessing typical daily behavior using a structured interview with behavioral anchor points. Scale is rated 1 to 6 with higher scores indicating lower levels of engagement in daily activity (i.e. more severe apathy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Multnomah Community Ability Scale mean score</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>Assessment of community functioning on a 17 -item scale with domains assessing interference with functioning, adjustment to living, social competence and behavioral problems. Items are averaged to produce a mean score. Items are each rated on a scale from 1-5 with higher scores reflecting better community functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Adherence Estimate Score</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>A 3 item scale assessing variables associated with adherence. Items are rated based upon self report about the importance of taking medication, worry about medication and financial burden of medication on a scale from agree completely to disagree completely. Each answer is assigned points based on an algorithm and added producing a total score. Higher scores indicate a higher risk for adherence and a lower probability of adherence. Scores range for 0 to 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Negative Symptom Assessment-16 Mean Score</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>Assesses 16 negative symptoms in the domains of communication, emotion/affect, social activity, motivation and psychomotor activity on a scale from 1-6. Items are added and divided by 16 to produce a mean score. A global score is also produced based upon clinical judgement following the interview Higher scores reflect higher levels of negative symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>24 item scale assessing multiple dimensions of psychopathology including positive symptoms; negative symptoms, anxiety/depression, and activation on a series of 7 point scales. Higher scores reflect higher levels of symptoms.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Effort Expenditure for Rewards Task (EEfRT) Probability Difference score</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>computerized task of effort put forth to win various amounts of money under various levels of probability. The probability difference score equals the percent of hard choices in the high probability condition minus the percent of hard choices in the low probability condition. Higher scores indicate more frequent choices of hard tasks at the high versus low probability level. individuals who answer the same way on all tasks are eliminated (estimate 1%)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in global score of Brief Assessment of Cognition (BACS) App</measure>
    <time_frame>baseline, 6 months, 12 months</time_frame>
    <description>Ipad delivered version of BACS assessing memory, attention, executive function and psychomotor speed. Standard scores are generated and summed to create a global cognition score with higher scores indicating better levels of cognitive function.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">205</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizoaffective Disorder</condition>
  <arm_group>
    <arm_group_label>Cognitive Adaptation Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Psychosocial treatment using environmental supports such as signs, alarms, pill containers, checklists, technology and the organization of belongings established in a person's home or work environment to bypass the cognitive and motivational difficulties associated with schizophrenia, and support habits for functional behavior to promote recovery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medication follow-up and case management as provided by the community mental health center according to usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Adaptation Training</intervention_name>
    <description>Psychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior</description>
    <arm_group_label>Cognitive Adaptation Training</arm_group_label>
    <other_name>CAT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community Treatment</intervention_name>
    <description>Medication follow-up and case management as provided in usual community care in the setting</description>
    <arm_group_label>Community Treatment</arm_group_label>
    <other_name>CT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females who have given informed consent.&#xD;
&#xD;
          2. Between the ages of 18 and 65.&#xD;
&#xD;
          3. Clinical Diagnosis of Schizophrenia, or Schizoaffective Disorder&#xD;
&#xD;
          4. Able to provide evidence of a stable living environment (individual apartment, family&#xD;
             home, board and care facility) within the last three months and no plans to move in&#xD;
             the next year.&#xD;
&#xD;
          5. Able to understand and complete rating scales and assessments.&#xD;
&#xD;
          6. Agree to home visits&#xD;
&#xD;
          7. Be able to have reimbursed home visits as part of treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Alcohol or drug or dependence within the past 2 months.&#xD;
&#xD;
          2. Currently being treated by an Assertive Community Treatment (ACT) team.&#xD;
&#xD;
          3. History of assault within the past year or other conditions that in the judgement of&#xD;
             the treatment team make home visits unsafe.&#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_official>
    <last_name>Dawn Velligan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>United Services Inc.</name>
      <address>
        <city>Dayville</city>
        <state>Connecticut</state>
        <zip>06241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henderson Behavioral Health</name>
      <address>
        <city>Lauderdale Lakes</city>
        <state>Florida</state>
        <zip>33319</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chestnut Health Systems</name>
      <address>
        <city>Granite City</city>
        <state>Illinois</state>
        <zip>62040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Mental Health Center Inc.</name>
      <address>
        <city>Lawrenceburg</city>
        <state>Indiana</state>
        <zip>47025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mental Health Center of Greater Manchester</name>
      <address>
        <city>Manchester</city>
        <state>New Hampshire</state>
        <zip>03101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peace Health</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Center</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Harris Center for Mental Health &amp; IDD</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center at San Antonio</investigator_affiliation>
    <investigator_full_name>Dawn Velligan</investigator_full_name>
    <investigator_title>Henry B. Dielmann Chair of Psychiatry and Behavioral Sciences</investigator_title>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Cognitive Adaptation Training</keyword>
  <keyword>Functional Outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators will be fully compliant with the NIMH Data Archive Data Sharing Terms and Conditions, including submitting and harmonizing all descriptive/raw data and analyzed data generated by the grant at the item and subject-level to the National Database for Clinical Trials (NDCT). All submitted data will include a Global Unique Identifier (GUID) and will not include personally identifiable information (PII).</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>6 mos following publication of the primary outcomes of the study and extending for a period of 2 years</ipd_time_frame>
    <ipd_access_criteria>deidentified data only upon email request to PI with specific research questions and analysis plan.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03829280/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03829280
org study id: HSC20180237H
secondary id: 1R01MH117101-01
nct id: NCT03829280
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators propose a cluster randomized effectiveness trial comparing Cognitive
      Adaptation Training (CAT; a psychosocial treatment using environmental supports such as
      signs, alarms, pill containers, checklists, technology and the organization of belongings
      established in a person's home or work environment to bypass the cognitive and motivational
      difficulties associated with schizophrenia ) to existing community treatment (CT) for
      individuals with schizophrenia in 8 community mental health centers across multiple states
      including 400 participants. Mechanisms of action will be examined. Participants will be
      assessed at baseline and 6 and 12 months on measures of functional and community outcome,
      medication adherence, symptoms, habit formation and automaticity, cognition and motivation.
Schizophrenia remains one of the most disabling conditions world-wide with an economic burden
      that exceeded $155 billion dollars in fiscal year 2013 alone. Despite existing medication and
      community treatment, many individuals with this diagnosis continue to have poor outcomes and
      struggle toward recovery. CAT is a psychosocial treatment using environmental supports such
      as signs, alarms, pill containers, checklists, technology and the organization of belongings
      established in a person's home or work environment to bypass the cognitive and motivational
      difficulties associated with schizophrenia, and support habits for functional behavior to
      promote recovery. In a series of efficacy studies, CAT improved social and occupational
      functioning, symptoms, and adherence to medication, and reduced rates of readmission. The
      investigators propose a cluster randomized effectiveness trial comparing Cognitive Adaptation
      Training (CAT) to existing community treatment (CT) for individuals with schizophrenia in 8
      community mental health centers across multiple states including 400 participants. This would
      be the first large-scale effectiveness study of CAT for improving functional outcomes for
      those with schizophrenia seen in community mental health centers (CMHCs) where the majority
      of those with schizophrenia are followed for outpatient care and to study the purported
      mechanisms of action based on an integrated theoretical model. Participants will be assessed
      at baseline and 6 and 12 months on measures of functional and community outcome, medication
      adherence, symptoms, habit formation and automaticity, cognition and motivation. CAT
      treatment will be weekly for 6 months, biweekly for 3 months and monthly for the remainder of
      the trial. Purported mechanisms of action for CAT including bypassing impairments in
      cognitive function to improve functional outcome and bypassing motivational impairments to
      create automatic habits to improve functional outcome will be examined.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster Randomized clinical trial conducted at 8 community mental health outpatient treatment sites across the country
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Raters assessing clinical outcome variables are centralized raters who are blind to treatment group as well as study design and aims.
measure: Change in Social and Occupational Functioning Scale Scores
time frame: baseline, 6 months, 12 months
description: A rating from 0-100 reflecting global level of Social and Occupational functioning; Higher scores indicate better functioning.
measure: Change in Daily activity
time frame: baseline, 6 months, 12 months
description: Negative Symptom Assessment item 14 assessing typical daily behavior using a structured interview with behavioral anchor points. Scale is rated 1 to 6 with higher scores indicating lower levels of engagement in daily activity (i.e. more severe apathy)
measure: Change in Multnomah Community Ability Scale mean score
time frame: baseline, 6 months, 12 months
description: Assessment of community functioning on a 17 -item scale with domains assessing interference with functioning, adjustment to living, social competence and behavioral problems. Items are averaged to produce a mean score. Items are each rated on a scale from 1-5 with higher scores reflecting better community functioning.
measure: Change in Adherence Estimate Score
time frame: baseline, 6 months, 12 months
description: A 3 item scale assessing variables associated with adherence. Items are rated based upon self report about the importance of taking medication, worry about medication and financial burden of medication on a scale from agree completely to disagree completely. Each answer is assigned points based on an algorithm and added producing a total score. Higher scores indicate a higher risk for adherence and a lower probability of adherence. Scores range for 0 to 100.
measure: Change in Negative Symptom Assessment-16 Mean Score
time frame: baseline, 6 months, 12 months
description: Assesses 16 negative symptoms in the domains of communication, emotion/affect, social activity, motivation and psychomotor activity on a scale from 1-6. Items are added and divided by 16 to produce a mean score. A global score is also produced based upon clinical judgement following the interview Higher scores reflect higher levels of negative symptoms.
measure: Change in the Expanded Version Brief Psychiatric Rating Scale (BPRS)-total score
time frame: baseline, 6 months, 12 months
description: 24 item scale assessing multiple dimensions of psychopathology including positive symptoms; negative symptoms, anxiety/depression, and activation on a series of 7 point scales. Higher scores reflect higher levels of symptoms.
measure: Change in Effort Expenditure for Rewards Task (EEfRT) Probability Difference score
time frame: baseline, 6 months, 12 months
description: computerized task of effort put forth to win various amounts of money under various levels of probability. The probability difference score equals the percent of hard choices in the high probability condition minus the percent of hard choices in the low probability condition. Higher scores indicate more frequent choices of hard tasks at the high versus low probability level. individuals who answer the same way on all tasks are eliminated (estimate 1%)
measure: Change in global score of Brief Assessment of Cognition (BACS) App
time frame: baseline, 6 months, 12 months
description: Ipad delivered version of BACS assessing memory, attention, executive function and psychomotor speed. Standard scores are generated and summed to create a global cognition score with higher scores indicating better levels of cognitive function.
arm group label: Cognitive Adaptation Training
arm group type: Experimental
description: Psychosocial treatment using environmental supports such as signs, alarms, pill containers, checklists, technology and the organization of belongings established in a person's home or work environment to bypass the cognitive and motivational difficulties associated with schizophrenia, and support habits for functional behavior to promote recovery.
arm group label: Community Treatment
arm group type: Active Comparator
description: Medication follow-up and case management as provided by the community mental health center according to usual care.
intervention type: Behavioral
intervention name: Cognitive Adaptation Training
description: Psychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior
arm group label: Cognitive Adaptation Training
other name: CAT
intervention type: Behavioral
intervention name: Community Treatment
description: Medication follow-up and case management as provided in usual community care in the setting
arm group label: Community Treatment
other name: CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dawn Velligan, PhD
role: Principal Investigator
affiliation: University of Texas
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center at San Antonio
investigator full name: Dawn Velligan
investigator title: Henry B. Dielmann Chair of Psychiatry and Behavioral Sciences
mesh term: Schizophrenia
mesh term: Psychotic Disorders
sharing ipd: Yes
ipd description: The investigators will be fully compliant with the NIMH Data Archive Data Sharing Terms and Conditions, including submitting and harmonizing all descriptive/raw data and analyzed data generated by the grant at the item and subject-level to the National Database for Clinical Trials (NDCT). All submitted data will include a Global Unique Identifier (GUID) and will not include personally identifiable information (PII).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: 6 mos following publication of the primary outcomes of the study and extending for a period of 2 years
ipd access criteria: deidentified data only upon email request to PI with specific research questions and analysis plan.
provided document: 