<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/NCT02254733</url>
  </required_header>
  <id_info>
    <org_study_id>5R01MH091057</org_study_id>
    <secondary_id>5R01MH091057</secondary_id>
    <nct_id>NCT02254733</nct_id>
  </id_info>
  <brief_title>Assertive Community Treatment With CBT and SST for Schizophrenia</brief_title>
  <official_title>Enhancing Assertive Community Treatment With Cognitive Behavioral Therapy and Social Skills Training for Schizophrenia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Veterans Medical Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Veterans Medical Research Foundation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is an effectiveness trial comparing two psychosocial treatments for&#xD;
      schizophrenia: Assertive Community Treatment (ACT) + Cognitive Behavioral Social Skills&#xD;
      Training (CBSST) v. ACT, alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assertive community treatment (ACT) is one of the most well-validated treatment models for&#xD;
      people with severe mental illness, and ACT is one of the few evidence-based practices that is&#xD;
      widely implemented in community mental health programs; however, existing ACT approaches have&#xD;
      little impact on functioning. The ACT model provides a unique opportunity for implementation&#xD;
      of recovery-oriented EBPs throughout community mental health programs in the US. This project&#xD;
      will examine the incremental effectiveness of implementing cognitive-behavioral strategies&#xD;
      and social skills training in ACT relative to ACT, alone. The investigators will begin to&#xD;
      examine a potential mechanism of change involving defeatist performance beliefs that can&#xD;
      interfere with performance of community functioning behaviors, and will use qualitative&#xD;
      methods to identify barriers and factors that contribute to successful implementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Independent Living Skills Survey (ILSS)</measure>
    <time_frame>Baseline, 18 mos.</time_frame>
    <description>The ILSS is 70 item self-report measure in an interview format to assess everyday functioning. Each item is rated from 0 (No) to 1 (Yes). Scales are summed to yield a total score. Higher scores represent a higher level of functioning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Expanded Brief Psychiatric Rating Scale (BPRS) - Positive symptom factor structure</measure>
    <time_frame>Baseline, 18 mos.</time_frame>
    <description>The expanded BPRS is a 24-item scale that measures psychiatric symptom severity. Each item is rated from 1 (not reported) to 7 (very severe). Items are summed to yield a total factor score. Higher scores represent higher positive symptom severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scale for Assessment of Negative Symptoms (SANS)</measure>
    <time_frame>Baseline, 18 mos.</time_frame>
    <description>The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. The first 13 items measure diminished expression which consists of two domains: Affective flattening and Alogia. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #8 and #13)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Defeatist Performance Attitude Scale (DPAS)</measure>
    <time_frame>Baseline, 18 mos.</time_frame>
    <description>The DPAS is a 15-item self-report subscale of the commonly-used 40-item Dysfunctional Attitude Scale (DAS) used to measure generalized defeatist beliefs about one's ability to perform tasks and effectiveness of social behaviors. Each item is rated from 1 (agree completely) to 7 (disagree completely). Higher total scores (range = 15-105) indicate more severe defeatist performance attitudes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maryland Assessment of Social Competence (MASC)</measure>
    <time_frame>Baseline, 18 mos.</time_frame>
    <description>The MASC is a structured behavioral role play assessment that measures the ability to resolve interpersonal problems through conversation in three role play scenarios. Videotaped role plays are rated by blinded raters on three dimensions; verbal content, nonverbal communication behavior, and overall effectiveness, which will be the primary MASC variable. Each item is rated from 1 (very poor) to 5 (very good). A higher score for that dimension reflects higher ability and skills to solve problems in an interpersonal context.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comprehensive Modules Test (CMT)</measure>
    <time_frame>Baseline, 18 mos.</time_frame>
    <description>The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition. Scores are summed to yield a total CMT score range from 0-33. Higher total scores represent higher level of CBSST skills acquisition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Therapy Scale for Psychosis (CTS-Psy)</measure>
    <time_frame>Baseline, 18 mos</time_frame>
    <description>The Cognitive Therapy Scale for Psychosis (CTS-Psy) is 10 item scale for assessing the quality of cognitive behavior therapy. Items are scored on a scale from 0 to 6, where the total maximum achievable is 60. Higher scores indicate greater level of competency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dartmouth Assertive Community Treatment Scale (DACTS)</measure>
    <time_frame>Baseline, 18 mos</time_frame>
    <description>The DACTS is an assessment of assertive community treatment service fidelity. It consists of 28 items, each rated on a behaviorally-anchored scale from 1(not implemented) to 5 (fully implemented). The mean score for the total scale will be used as the measure of ACT team fidelity. A DACTS score of &gt;4.0 is considered moderately high fidelity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">178</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>ACT + CBSST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implementing Cognitive Behavioral Social Skills Training in an Assertive Community Treatment model</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACT only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Assertive Community Treatment only</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Social Skills Training (CBSST)</intervention_name>
    <description>CBSST integrates CBT and SST techniques and neurocognitive compensatory aids. The treatment manual includes a patient workbook that describes the skills and includes homework assignment forms. Cognitive therapy is combined with role play practice of communication skills and problem-solving training. The ACT-adapted, team-delivered individual CBSST intervention will be delivered in 3 6-session modules (Cognitive Skills, Social Skills, and Problem Solving Skills) for a total of 18 weekly individual therapy sessions, but with participants completing the sequence of 3 modules twice, for a total of 36 sessions (9 months).</description>
    <arm_group_label>ACT + CBSST</arm_group_label>
    <other_name>CBT</other_name>
    <other_name>SST</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assertive Community Treatment (ACT)</intervention_name>
    <description>Assertive Community Treatment model is a evidence based practice model. ACT teams are multi-disciplinary and provide comprehensive services to individuals in their natural setting with small staff to recipient ratio. ACT teams use assertive engagement to proactively engage individuals in treatment providing services and support directly to individuals that are tailored to meet their specific goals and needs.</description>
    <arm_group_label>ACT only</arm_group_label>
    <other_name>ACT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DSM-IV-diagnosis of schizophrenia or schizoaffective disorder at any stage of illness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable assignment (at least 3 months) to an ACT team;&#xD;
&#xD;
          -  Prior exposure to SST or CBT in the past 5 years&#xD;
&#xD;
          -  Level of care required interferes with outpatient therapy (e.g., current&#xD;
             hospitalization for psychiatric, substance use or physical illness).&#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_official>
    <last_name>Eric Granholm, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Diego Veterans Healthcare System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA San Diego Healthcare System</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wykes T, Steel C, Everitt B, Tarrier N. Cognitive behavior therapy for schizophrenia: effect sizes, clinical models, and methodological rigor. Schizophr Bull. 2008 May;34(3):523-37. doi: 10.1093/schbul/sbm114. Epub 2007 Oct 25.</citation>
    <PMID>17962231</PMID>
  </reference>
  <reference>
    <citation>Kurtz MM, Mueser KT. A meta-analysis of controlled research on social skills training for schizophrenia. J Consult Clin Psychol. 2008 Jun;76(3):491-504. doi: 10.1037/0022-006X.76.3.491.</citation>
    <PMID>18540742</PMID>
  </reference>
  <reference>
    <citation>Granholm E, McQuaid JR, McClure FS, Auslander LA, Perivoliotis D, Pedrelli P, Patterson T, Jeste DV. A randomized, controlled trial of cognitive behavioral social skills training for middle-aged and older outpatients with chronic schizophrenia. Am J Psychiatry. 2005 Mar;162(3):520-9. doi: 10.1176/appi.ajp.162.3.520.</citation>
    <PMID>15741469</PMID>
  </reference>
  <reference>
    <citation>Granholm E, McQuaid JR, McClure FS, Link PC, Perivoliotis D, Gottlieb JD, Patterson TL, Jeste DV. Randomized controlled trial of cognitive behavioral social skills training for older people with schizophrenia: 12-month follow-up. J Clin Psychiatry. 2007 May;68(5):730-7. doi: 10.4088/jcp.v68n0510.</citation>
    <PMID>17503982</PMID>
  </reference>
  <reference>
    <citation>Aarons GA, Wells RS, Zagursky K, Fettes DL, Palinkas LA. Implementing evidence-based practice in community mental health agencies: a multiple stakeholder analysis. Am J Public Health. 2009 Nov;99(11):2087-95. doi: 10.2105/AJPH.2009.161711. Epub 2009 Sep 17.</citation>
    <PMID>19762654</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>April 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CBSST</keyword>
  <keyword>Schizoaffective Disorder</keyword>
  <keyword>Psychotic Disorder</keyword>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <keyword>Social Skills Training</keyword>
  <keyword>Assertive Community Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02254733
org study id: 5R01MH091057
secondary id: 5R01MH091057
nct id: NCT02254733
lead sponsor: 
collaborator: 
has dmc: Yes
This project is an effectiveness trial comparing two psychosocial treatments for
      schizophrenia: Assertive Community Treatment (ACT) + Cognitive Behavioral Social Skills
      Training (CBSST) v. ACT, alone.
Assertive community treatment (ACT) is one of the most well-validated treatment models for
      people with severe mental illness, and ACT is one of the few evidence-based practices that is
      widely implemented in community mental health programs; however, existing ACT approaches have
      little impact on functioning. The ACT model provides a unique opportunity for implementation
      of recovery-oriented EBPs throughout community mental health programs in the US. This project
      will examine the incremental effectiveness of implementing cognitive-behavioral strategies
      and social skills training in ACT relative to ACT, alone. The investigators will begin to
      examine a potential mechanism of change involving defeatist performance beliefs that can
      interfere with performance of community functioning behaviors, and will use qualitative
      methods to identify barriers and factors that contribute to successful implementation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Independent Living Skills Survey (ILSS)
time frame: Baseline, 18 mos.
description: The ILSS is 70 item self-report measure in an interview format to assess everyday functioning. Each item is rated from 0 (No) to 1 (Yes). Scales are summed to yield a total score. Higher scores represent a higher level of functioning.
measure: Expanded Brief Psychiatric Rating Scale (BPRS) - Positive symptom factor structure
time frame: Baseline, 18 mos.
description: The expanded BPRS is a 24-item scale that measures psychiatric symptom severity. Each item is rated from 1 (not reported) to 7 (very severe). Items are summed to yield a total factor score. Higher scores represent higher positive symptom severity.
measure: Scale for Assessment of Negative Symptoms (SANS)
time frame: Baseline, 18 mos.
description: The SANS is a 25 item semi-structured clinical interview designed to assess negative symptoms. The first 13 items measure diminished expression which consists of two domains: Affective flattening and Alogia. Each item is rated from 0 (Absent) to 5 (Severe). The total score is derived from the average of the Affective Flattening and Alogia global ratings (items #8 and #13)
measure: Defeatist Performance Attitude Scale (DPAS)
time frame: Baseline, 18 mos.
description: The DPAS is a 15-item self-report subscale of the commonly-used 40-item Dysfunctional Attitude Scale (DAS) used to measure generalized defeatist beliefs about one's ability to perform tasks and effectiveness of social behaviors. Each item is rated from 1 (agree completely) to 7 (disagree completely). Higher total scores (range = 15-105) indicate more severe defeatist performance attitudes.
measure: Maryland Assessment of Social Competence (MASC)
time frame: Baseline, 18 mos.
description: The MASC is a structured behavioral role play assessment that measures the ability to resolve interpersonal problems through conversation in three role play scenarios. Videotaped role plays are rated by blinded raters on three dimensions; verbal content, nonverbal communication behavior, and overall effectiveness, which will be the primary MASC variable. Each item is rated from 1 (very poor) to 5 (very good). A higher score for that dimension reflects higher ability and skills to solve problems in an interpersonal context.
measure: Comprehensive Modules Test (CMT)
time frame: Baseline, 18 mos.
description: The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition. Scores are summed to yield a total CMT score range from 0-33. Higher total scores represent higher level of CBSST skills acquisition.
measure: Cognitive Therapy Scale for Psychosis (CTS-Psy)
time frame: Baseline, 18 mos
description: The Cognitive Therapy Scale for Psychosis (CTS-Psy) is 10 item scale for assessing the quality of cognitive behavior therapy. Items are scored on a scale from 0 to 6, where the total maximum achievable is 60. Higher scores indicate greater level of competency.
measure: Dartmouth Assertive Community Treatment Scale (DACTS)
time frame: Baseline, 18 mos
description: The DACTS is an assessment of assertive community treatment service fidelity. It consists of 28 items, each rated on a behaviorally-anchored scale from 1(not implemented) to 5 (fully implemented). The mean score for the total scale will be used as the measure of ACT team fidelity. A DACTS score of >4.0 is considered moderately high fidelity.
arm group label: ACT + CBSST
arm group type: Experimental
description: Implementing Cognitive Behavioral Social Skills Training in an Assertive Community Treatment model
arm group label: ACT only
arm group type: Active Comparator
description: Assertive Community Treatment only
intervention type: Behavioral
intervention name: Cognitive Behavioral Social Skills Training (CBSST)
description: CBSST integrates CBT and SST techniques and neurocognitive compensatory aids. The treatment manual includes a patient workbook that describes the skills and includes homework assignment forms. Cognitive therapy is combined with role play practice of communication skills and problem-solving training. The ACT-adapted, team-delivered individual CBSST intervention will be delivered in 3 6-session modules (Cognitive Skills, Social Skills, and Problem Solving Skills) for a total of 18 weekly individual therapy sessions, but with participants completing the sequence of 3 modules twice, for a total of 36 sessions (9 months).
arm group label: ACT + CBSST
other name: CBT
other name: SST
intervention type: Other
intervention name: Assertive Community Treatment (ACT)
description: Assertive Community Treatment model is a evidence based practice model. ACT teams are multi-disciplinary and provide comprehensive services to individuals in their natural setting with small staff to recipient ratio. ACT teams use assertive engagement to proactively engage individuals in treatment providing services and support directly to individuals that are tailored to meet their specific goals and needs.
arm group label: ACT only
other name: ACT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Granholm, PhD
role: Principal Investigator
affiliation: San Diego Veterans Healthcare System
facility: 
country: United States
citation: Wykes T, Steel C, Everitt B, Tarrier N. Cognitive behavior therapy for schizophrenia: effect sizes, clinical models, and methodological rigor. Schizophr Bull. 2008 May;34(3):523-37. doi: 10.1093/schbul/sbm114. Epub 2007 Oct 25.
PMID: 17962231
citation: Kurtz MM, Mueser KT. A meta-analysis of controlled research on social skills training for schizophrenia. J Consult Clin Psychol. 2008 Jun;76(3):491-504. doi: 10.1037/0022-006X.76.3.491.
PMID: 18540742
citation: Granholm E, McQuaid JR, McClure FS, Auslander LA, Perivoliotis D, Pedrelli P, Patterson T, Jeste DV. A randomized, controlled trial of cognitive behavioral social skills training for middle-aged and older outpatients with chronic schizophrenia. Am J Psychiatry. 2005 Mar;162(3):520-9. doi: 10.1176/appi.ajp.162.3.520.
PMID: 15741469
citation: Granholm E, McQuaid JR, McClure FS, Link PC, Perivoliotis D, Gottlieb JD, Patterson TL, Jeste DV. Randomized controlled trial of cognitive behavioral social skills training for older people with schizophrenia: 12-month follow-up. J Clin Psychiatry. 2007 May;68(5):730-7. doi: 10.4088/jcp.v68n0510.
PMID: 17503982
citation: Aarons GA, Wells RS, Zagursky K, Fettes DL, Palinkas LA. Implementing evidence-based practice in community mental health agencies: a multiple stakeholder analysis. Am J Public Health. 2009 Nov;99(11):2087-95. doi: 10.2105/AJPH.2009.161711. Epub 2009 Sep 17.
PMID: 19762654
responsible party type: Sponsor
mesh term: Schizophrenia
sharing ipd: No