<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/NCT02183844</url>
  </required_header>
  <id_info>
    <org_study_id>R21MH100565</org_study_id>
    <nct_id>NCT02183844</nct_id>
  </id_info>
  <brief_title>A System for Preference Assessment in Mental Health</brief_title>
  <acronym>SPA</acronym>
  <official_title>Implementing Patient-Centered Decision Support for Mental Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Los Angeles County Department of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Los Angeles County Department of Mental Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</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>
      It is important that individuals with serious mental illness make informed choices among&#xD;
      alternative healthcare treatments based on their preferences. However, at present,&#xD;
      individuals' preferences are often not being elicited, nor used to guide which treatments are&#xD;
      made available. In this pilot project, the investigators implement and evaluate a&#xD;
      computerized method for assessing treatment preferences of individuals with schizophrenia.&#xD;
      The investigators use weight management treatments for this initial test of the system. If&#xD;
      this assessment method is found to predict treatment use and satisfaction, it can be used to&#xD;
      guide implementation of treatments that improve outcomes while meeting individuals'&#xD;
      preferences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background/Rationale: It is important that individuals with serious mental illness have&#xD;
      access to treatments that meet their preferences, and that they make informed choices among&#xD;
      alternative treatments. Too often, preferences are not being routinely elicited, nor used to&#xD;
      guide which treatments are made available. Schizophrenia is a serious mental illness that is&#xD;
      common and produces substantial disability when poorly treated. National treatment guidelines&#xD;
      specify that individuals with schizophrenia should receive evidence-based treatments that&#xD;
      improve outcomes. For example, obesity is a pressing problem in this population, a&#xD;
      side-effect of commonly used medications, and a cause of cardiovascular disease and premature&#xD;
      mortality. There are multiple, different psychosocial interventions for weight management&#xD;
      that can lead to reduced weight. None are widely used. If individuals' preferences were&#xD;
      routinely assessed, then clinicians and managers would know when to make alternative&#xD;
      treatments available.&#xD;
&#xD;
      Objectives: This project implements and evaluates a method for routinely assessing the&#xD;
      treatment preferences of individuals with schizophrenia. The objectives are to: 1) develop a&#xD;
      computerized, kiosk-based system that delivers education regarding treatment options for&#xD;
      weight, uses conjoint analysis to elicit preferences, and meets the cognitive needs of&#xD;
      individuals with schizophrenia; 2) study the feasibility and acceptability of implementing&#xD;
      this method at a mental health clinic; and, 3) evaluate the extent to which this method&#xD;
      predicts use of evidence-based weight services, and satisfaction with services at three&#xD;
      months.&#xD;
&#xD;
      Methods: This is a prospective evaluation of preferences, treatment use, and satisfaction in&#xD;
      individuals with schizophrenia. 94 individuals are enrolled who are overweight and receiving&#xD;
      treatment at a busy, urban mental health clinic. These participants use a kiosk system that&#xD;
      provides them with education about treatment options, and assesses their preferences&#xD;
      regarding alternative treatments for weight. They are then offered a weekly, intensive,&#xD;
      evidence-based psychosocial treatment for weight. Research assessments occur at baseline and&#xD;
      3 months. Treatment preferences are analyzed to determine how they relate to use of weight&#xD;
      treatment, and satisfaction with treatment.&#xD;
&#xD;
      Significance: People with serious mental illness could benefit from access to effective&#xD;
      treatments. Implementing these treatments would be facilitated by routinely collecting&#xD;
      information regarding individuals' preferences. If the assessment method in this study is&#xD;
      found to be feasible, acceptable, and accurate, it could be used to support implementation of&#xD;
      improved care at clinics, medical centers, and community-based programs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2014</start_date>
  <completion_date type="Actual">October 31, 2017</completion_date>
  <primary_completion_date type="Actual">October 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Days until using weight services</measure>
    <time_frame>3 months</time_frame>
    <description>Utilization of the weight services offered. This includes the number of days until starting to use weight services. This is assessed using information regarding attendance at weight services, and by survey administered by interview.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant preferences regarding weight services</measure>
    <time_frame>Baseline</time_frame>
    <description>Individuals' preferences are assessed regarding different attributes of weight treatments. These are assessed using computerized conjoint analysis methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with the weight services provided</measure>
    <time_frame>3 months</time_frame>
    <description>Satisfaction with the weight services provided. This is assessed using the Client Satisfaction Questionnaire administered by interview.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of weight services used</measure>
    <time_frame>3 months</time_frame>
    <description>Utilization of the weight services offered. This includes the number of weight service sessions attended. This is assessed using information regarding attendance at weight services, and by survey administered by interview.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility and acceptability of implementing preference assessment</measure>
    <time_frame>Baseline</time_frame>
    <description>Feasibility and acceptability of implementing kiosk-based preference assessment at a mental health clinic. This is assessed using project records, surveys, and semi-structured interview questions assessing whether participants and staff find the program and its components to be advantageous, relevant, simple, easy to use, and beneficial.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Aspects of the Theory of Planned Behavior</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Attitudes, subjective norms, perceived control, and behavioral intentions regarding weight loss. These are assessed by interview, using scales from the Theory of Planned Behavior.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Mental Disorders</condition>
  <condition>Schizophrenia</condition>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Psychosocial Weight Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychosocial Weight Intervention</intervention_name>
    <description>Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses</description>
    <arm_group_label>Psychosocial Weight Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. diagnosis of schizophrenia&#xD;
&#xD;
          2. age 18 or older&#xD;
&#xD;
          3. Body Mass Index (BMI) of either 28.0-29.9 and gained 10 pounds in the last 3 months;&#xD;
             OR, BMI of 30 or above&#xD;
&#xD;
          4. able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. a medical condition for which a weight program is contraindicated&#xD;
&#xD;
          2. pregnant and nursing mothers&#xD;
&#xD;
          3. attendance at a psychosocial intervention for weight management in the past month&#xD;
&#xD;
          4. individuals with legal conservators who manage informed consent&#xD;
&#xD;
          5. can not speak English&#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>Alexander S Young, MD, MSHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Center for Health Services and Society</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Young AS, Niv N, Chinman M, Dixon L, Eisen SV, Fischer EP, Smith J, Valenstein M, Marder SR, Owen RR. Routine outcomes monitoring to support improving care for schizophrenia: report from the VA Mental Health QUERI. Community Ment Health J. 2011 Apr;47(2):123-35. doi: 10.1007/s10597-010-9328-y. Epub 2010 Jul 25.</citation>
    <PMID>20658320</PMID>
  </reference>
  <reference>
    <citation>Cohen AN, Chinman MJ, Hamilton AB, Whelan F, Young AS. Using patient-facing kiosks to support quality improvement at mental health clinics. Med Care. 2013 Mar;51(3 Suppl 1):S13-20. doi: 10.1097/MLR.0b013e31827da859.</citation>
    <PMID>23407006</PMID>
  </reference>
  <reference>
    <citation>Brown AH, Cohen AN, Chinman MJ, Kessler C, Young AS. EQUIP: implementing chronic care principles and applying formative evaluation methods to improve care for schizophrenia: QUERI Series. Implement Sci. 2008 Feb 15;3:9. doi: 10.1186/1748-5908-3-9.</citation>
    <PMID>18279505</PMID>
  </reference>
  <reference>
    <citation>Chinman M, Young AS, Schell T, Hassell J, Mintz J. Computer-assisted self-assessment in persons with severe mental illness. J Clin Psychiatry. 2004 Oct;65(10):1343-51. doi: 10.4088/jcp.v65n1008.</citation>
    <PMID>15491237</PMID>
  </reference>
  <reference>
    <citation>Young AS. The client, the clinician, and the computer. Psychiatr Serv. 2010 Jul;61(7):643. doi: 10.1176/ps.2010.61.7.643. No abstract available.</citation>
    <PMID>20591993</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>November 2, 2017</last_update_submitted>
  <last_update_submitted_qc>November 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Alexander S. Young, MD MSHS</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Medical Informatics</keyword>
  <keyword>Patient-Centered</keyword>
  <keyword>Healthcare Preferences</keyword>
  <keyword>Health Education</keyword>
  <keyword>Quality Improvement</keyword>
  <keyword>Weight Loss</keyword>
  <keyword>Personal Satisfaction</keyword>
  <keyword>Humans</keyword>
  <keyword>Cognition</keyword>
  <keyword>Body Weight</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Mental Disorders</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/NCT02183844
org study id: R21MH100565
nct id: NCT02183844
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is important that individuals with serious mental illness make informed choices among
      alternative healthcare treatments based on their preferences. However, at present,
      individuals' preferences are often not being elicited, nor used to guide which treatments are
      made available. In this pilot project, the investigators implement and evaluate a
      computerized method for assessing treatment preferences of individuals with schizophrenia.
      The investigators use weight management treatments for this initial test of the system. If
      this assessment method is found to predict treatment use and satisfaction, it can be used to
      guide implementation of treatments that improve outcomes while meeting individuals'
      preferences.
Background/Rationale: It is important that individuals with serious mental illness have
      access to treatments that meet their preferences, and that they make informed choices among
      alternative treatments. Too often, preferences are not being routinely elicited, nor used to
      guide which treatments are made available. Schizophrenia is a serious mental illness that is
      common and produces substantial disability when poorly treated. National treatment guidelines
      specify that individuals with schizophrenia should receive evidence-based treatments that
      improve outcomes. For example, obesity is a pressing problem in this population, a
      side-effect of commonly used medications, and a cause of cardiovascular disease and premature
      mortality. There are multiple, different psychosocial interventions for weight management
      that can lead to reduced weight. None are widely used. If individuals' preferences were
      routinely assessed, then clinicians and managers would know when to make alternative
      treatments available.

      Objectives: This project implements and evaluates a method for routinely assessing the
      treatment preferences of individuals with schizophrenia. The objectives are to: 1) develop a
      computerized, kiosk-based system that delivers education regarding treatment options for
      weight, uses conjoint analysis to elicit preferences, and meets the cognitive needs of
      individuals with schizophrenia; 2) study the feasibility and acceptability of implementing
      this method at a mental health clinic; and, 3) evaluate the extent to which this method
      predicts use of evidence-based weight services, and satisfaction with services at three
      months.

      Methods: This is a prospective evaluation of preferences, treatment use, and satisfaction in
      individuals with schizophrenia. 94 individuals are enrolled who are overweight and receiving
      treatment at a busy, urban mental health clinic. These participants use a kiosk system that
      provides them with education about treatment options, and assesses their preferences
      regarding alternative treatments for weight. They are then offered a weekly, intensive,
      evidence-based psychosocial treatment for weight. Research assessments occur at baseline and
      3 months. Treatment preferences are analyzed to determine how they relate to use of weight
      treatment, and satisfaction with treatment.

      Significance: People with serious mental illness could benefit from access to effective
      treatments. Implementing these treatments would be facilitated by routinely collecting
      information regarding individuals' preferences. If the assessment method in this study is
      found to be feasible, acceptable, and accurate, it could be used to support implementation of
      improved care at clinics, medical centers, and community-based programs.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Days until using weight services
time frame: 3 months
description: Utilization of the weight services offered. This includes the number of days until starting to use weight services. This is assessed using information regarding attendance at weight services, and by survey administered by interview.
measure: Participant preferences regarding weight services
time frame: Baseline
description: Individuals' preferences are assessed regarding different attributes of weight treatments. These are assessed using computerized conjoint analysis methods.
measure: Satisfaction with the weight services provided
time frame: 3 months
description: Satisfaction with the weight services provided. This is assessed using the Client Satisfaction Questionnaire administered by interview.
measure: Number of weight services used
time frame: 3 months
description: Utilization of the weight services offered. This includes the number of weight service sessions attended. This is assessed using information regarding attendance at weight services, and by survey administered by interview.
measure: Feasibility and acceptability of implementing preference assessment
time frame: Baseline
description: Feasibility and acceptability of implementing kiosk-based preference assessment at a mental health clinic. This is assessed using project records, surveys, and semi-structured interview questions assessing whether participants and staff find the program and its components to be advantageous, relevant, simple, easy to use, and beneficial.
measure: Aspects of the Theory of Planned Behavior
time frame: Baseline and 3 months
description: Attitudes, subjective norms, perceived control, and behavioral intentions regarding weight loss. These are assessed by interview, using scales from the Theory of Planned Behavior.
arm group label: Psychosocial Weight Intervention
arm group type: Experimental
description: Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses
intervention type: Behavioral
intervention name: Psychosocial Weight Intervention
description: Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses
arm group label: Psychosocial Weight Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander S Young, MD, MSHS
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
citation: Young AS, Niv N, Chinman M, Dixon L, Eisen SV, Fischer EP, Smith J, Valenstein M, Marder SR, Owen RR. Routine outcomes monitoring to support improving care for schizophrenia: report from the VA Mental Health QUERI. Community Ment Health J. 2011 Apr;47(2):123-35. doi: 10.1007/s10597-010-9328-y. Epub 2010 Jul 25.
PMID: 20658320
citation: Cohen AN, Chinman MJ, Hamilton AB, Whelan F, Young AS. Using patient-facing kiosks to support quality improvement at mental health clinics. Med Care. 2013 Mar;51(3 Suppl 1):S13-20. doi: 10.1097/MLR.0b013e31827da859.
PMID: 23407006
citation: Brown AH, Cohen AN, Chinman MJ, Kessler C, Young AS. EQUIP: implementing chronic care principles and applying formative evaluation methods to improve care for schizophrenia: QUERI Series. Implement Sci. 2008 Feb 15;3:9. doi: 10.1186/1748-5908-3-9.
PMID: 18279505
citation: Chinman M, Young AS, Schell T, Hassell J, Mintz J. Computer-assisted self-assessment in persons with severe mental illness. J Clin Psychiatry. 2004 Oct;65(10):1343-51. doi: 10.4088/jcp.v65n1008.
PMID: 15491237
citation: Young AS. The client, the clinician, and the computer. Psychiatr Serv. 2010 Jul;61(7):643. doi: 10.1176/ps.2010.61.7.643. No abstract available.
PMID: 20591993
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Alexander S. Young, MD MSHS
investigator title: Professor
mesh term: Overweight
mesh term: Schizophrenia
mesh term: Mental Disorders
sharing ipd: No