<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/NCT04415437</url>
  </required_header>
  <id_info>
    <org_study_id>2019-53k</org_study_id>
    <nct_id>NCT04415437</nct_id>
  </id_info>
  <brief_title>Self-Stigma of Mental and Physical Health</brief_title>
  <official_title>Self-Stigma of Mental and Physical Health: Developing and Validation of a Universal Self-Stigma Scale (USSS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philipps University Marburg Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philipps University Marburg Medical Center</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>
      People with mental disorders often suffer from self-stigmatization. Self-stigma is associated&#xD;
      with several negative outcomes such as low quality of life, lower rates of help-seeking as&#xD;
      well as poorer treatment adherence. However, a lot of questionnaires only focus on specific&#xD;
      mental disorders. There is no valid measurement which can be used for all kinds of mental&#xD;
      disorders.&#xD;
&#xD;
      Furthermore, much less is known about self-stigma in people with organic diseases. Only&#xD;
      little attention has been given to those who may experience self-stigma because of their&#xD;
      physical condition. A main reason for this may be the lack of a valid measurement of&#xD;
      self-stigma among people with physical health issues.&#xD;
&#xD;
      Therefore, the aim of this study is to develop and validate a self-report scale which is&#xD;
      capable to do both - measuring self-stigma among people with all mental disorders and among&#xD;
      people with physical health issues.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Items are derived from the Stereotype Content Model (SCM) and the Behaviors from Intergroup&#xD;
      Affect and Stereotypes (BIAS) Map. Psychometric evaluation includes testing the reliability&#xD;
      (intern consistency, test-retest reliability) and validity (exploratory and confirmatory&#xD;
      factor analysis, construct validity incl. convergent and discriminant validity,&#xD;
      criterion-related validity).&#xD;
&#xD;
      Participants take part in an online survey. They answer general questions about their mental&#xD;
      and physical health condition and complete measurements of quality of life, mental health,&#xD;
      depression, public stigma, expected stigma, self-stigma, intention to seek help and actual&#xD;
      help seeking (behavior).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 4, 2019</start_date>
  <completion_date type="Actual">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Development of the Universal Self-Stigma Scale (USSS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Questionnaire is based on the Stereotype Content Model (Fiske et al., 2002) and BIAS-Map (Cuddy et al., 2007) and includes three components: stereotype (warmth, competence [lower scores indicate higher self-stigma]), prejudice (emotions, e.g. contempt, pity, anger, shame [higher scores indicate higher self-stigma]), discrimination (active/passive self-harm [higher scores indicate higher self-stigma]). Each item is rated on a 7-point Likert scale.&#xD;
Item selection via qualitative and statistical methods, e.g. item difficulty index, item discrimination index, exploratory factor analysis (EFA).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Universal Self-Stigma Scale (USSS): Validity</measure>
    <time_frame>Baseline</time_frame>
    <description>Validation process includes confirmatory factor analysis (CFA) to test the statistical model fit with goodness of fit indices. Convergent validity is tested with another measurement for self-stigma (ISMI) using Pearson correlations [higher correlations indicate better convergent validity]. Discriminant validity is tested with Beck Depression Inventory-II (BDI-II) and public stigma [lower correlations indicate better discriminant validity], criterion validity with actual help seeking behavior and health related quality of life (12-Item Short-Form Health Survey, SF-12) using Pearson correlations as well [higher correlations indicate better criterion validity].</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Universal Self-Stigma Scale (USSS): Internal consistency</measure>
    <time_frame>Baseline</time_frame>
    <description>Internal consistency is tested with Cronbach's Alpha (0-1; higher scores indicate better internal consistency)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change on Universal Self-Stigma Scale (USSS): Test-Retest Reliability</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Test-Retest Reliability (Pearson Correlation, 0-1; higher scores indicate better reliability)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intention to Seek Help</measure>
    <time_frame>Baseline</time_frame>
    <description>Questionaire (e.g. Yu et al., 2015) to describe the intention to seek help because of severe psychological or mental health problems as well as physical health problems (e.g. &quot;If you had severe mental health problems, would you seek help from professional sources for them?&quot;, scores from 1 [definitely yes] to 4 [definitely no]; lower scores indicate higher intentions to seek help). Reasons for not seeking help because of psychological health problems (e.g. &quot;I want to solve problems by myself.&quot;) are assessed by binary items (yes, no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actual Help Seeking Behavior</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>8 Items to assess actual help seeking behavior. It is asked if participants have ever sought services from any professional and if they have been in therapy or received medical treatment because of psychological or physical health problems. As well as if they are using any of these services currently. Items are binary (yes, no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-Item Short-Form Health Survey (SF-12)</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-report measure of health related quality of life; norm-based scores (M=50, SD=10) for Physical Component Summary (PCS) and Mental Component Summary (MCS), higher score indicates better health state</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ)</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-report inventory used to screen for mental health disorders (depression, anxiety, alcohol, eating, somatoform disorders), including severity scores for depressive symptoms (0-29), anxiety symptoms (0-21) and somatic symptoms (0-30), where higher scores indicate more serve symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory-II (BDI-II)</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-report measure of depressed mood; higher total scores indicate more servere symptoms; total score (0-63); cut-offs for interpretation 0-13 (minimal depression), 14-19 (mild depression), 20-28 (moderate depression), 29-63 (severe depression)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Public Stigma</measure>
    <time_frame>Baseline</time_frame>
    <description>Measuring public stigma including stereotype (cognition - warmth, competence), prejudice (emotions - pity, envy, contempt, admiration) and discrimination (behavior - active/passive harm) with 19 items based on Stereotype Content Model (Fiske et al., 2002) and BIAS Map (Cuddy et al., 2007) toward people with mental or physical health problems.&#xD;
(e.g. &quot;How often do you think people in general tend to feel the following emotions toward people with a mental disorder? [pity, contempt, envy, admiration]&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expected Stigma</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Expectation to be stigmatized because of one's own mental and physical health condition.&#xD;
(e.g. &quot;Do you expect that other people think badly of you because of your health condition?&quot;)</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">823</enrollment>
  <condition>Mental Disorder</condition>
  <condition>Organic Disease</condition>
  <arm_group>
    <arm_group_label>healthy</arm_group_label>
    <description>Healthy participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mentally ill</arm_group_label>
    <description>Participants with mental disorders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>physically ill</arm_group_label>
    <description>Participants with organic disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mentally and physically ill</arm_group_label>
    <description>Participants with mental disorders and organic disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Random sample including students, outpatients, inpatients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum Age: 18&#xD;
&#xD;
          -  Fluent in German Language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute psychosis&#xD;
&#xD;
          -  Suicidal ideation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg</name>
      <address>
        <city>Marburg</city>
        <zip>35032</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>September 14, 2021</last_update_submitted>
  <last_update_submitted_qc>September 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Self-Stigma</keyword>
  <keyword>Mental Health</keyword>
  <keyword>Physical Health</keyword>
  <keyword>Questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04415437
org study id: 2019-53k
nct id: NCT04415437
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
People with mental disorders often suffer from self-stigmatization. Self-stigma is associated
      with several negative outcomes such as low quality of life, lower rates of help-seeking as
      well as poorer treatment adherence. However, a lot of questionnaires only focus on specific
      mental disorders. There is no valid measurement which can be used for all kinds of mental
      disorders.

      Furthermore, much less is known about self-stigma in people with organic diseases. Only
      little attention has been given to those who may experience self-stigma because of their
      physical condition. A main reason for this may be the lack of a valid measurement of
      self-stigma among people with physical health issues.

      Therefore, the aim of this study is to develop and validate a self-report scale which is
      capable to do both - measuring self-stigma among people with all mental disorders and among
      people with physical health issues.
Items are derived from the Stereotype Content Model (SCM) and the Behaviors from Intergroup
      Affect and Stereotypes (BIAS) Map. Psychometric evaluation includes testing the reliability
      (intern consistency, test-retest reliability) and validity (exploratory and confirmatory
      factor analysis, construct validity incl. convergent and discriminant validity,
      criterion-related validity).

      Participants take part in an online survey. They answer general questions about their mental
      and physical health condition and complete measurements of quality of life, mental health,
      depression, public stigma, expected stigma, self-stigma, intention to seek help and actual
      help seeking (behavior).
observational model: Case-Control
time perspective: Prospective
measure: Development of the Universal Self-Stigma Scale (USSS)
time frame: Baseline
description: Questionnaire is based on the Stereotype Content Model (Fiske et al., 2002) and BIAS-Map (Cuddy et al., 2007) and includes three components: stereotype (warmth, competence [lower scores indicate higher self-stigma]), prejudice (emotions, e.g. contempt, pity, anger, shame [higher scores indicate higher self-stigma]), discrimination (active/passive self-harm [higher scores indicate higher self-stigma]). Each item is rated on a 7-point Likert scale.
Item selection via qualitative and statistical methods, e.g. item difficulty index, item discrimination index, exploratory factor analysis (EFA).
measure: Universal Self-Stigma Scale (USSS): Validity
time frame: Baseline
description: Validation process includes confirmatory factor analysis (CFA) to test the statistical model fit with goodness of fit indices. Convergent validity is tested with another measurement for self-stigma (ISMI) using Pearson correlations [higher correlations indicate better convergent validity]. Discriminant validity is tested with Beck Depression Inventory-II (BDI-II) and public stigma [lower correlations indicate better discriminant validity], criterion validity with actual help seeking behavior and health related quality of life (12-Item Short-Form Health Survey, SF-12) using Pearson correlations as well [higher correlations indicate better criterion validity].
measure: Universal Self-Stigma Scale (USSS): Internal consistency
time frame: Baseline
description: Internal consistency is tested with Cronbach's Alpha (0-1; higher scores indicate better internal consistency)
measure: Change on Universal Self-Stigma Scale (USSS): Test-Retest Reliability
time frame: Baseline and 4 weeks
description: Test-Retest Reliability (Pearson Correlation, 0-1; higher scores indicate better reliability)
measure: Intention to Seek Help
time frame: Baseline
description: Questionaire (e.g. Yu et al., 2015) to describe the intention to seek help because of severe psychological or mental health problems as well as physical health problems (e.g. "If you had severe mental health problems, would you seek help from professional sources for them?", scores from 1 [definitely yes] to 4 [definitely no]; lower scores indicate higher intentions to seek help). Reasons for not seeking help because of psychological health problems (e.g. "I want to solve problems by myself.") are assessed by binary items (yes, no).
measure: Actual Help Seeking Behavior
time frame: Baseline and 4 weeks
description: 8 Items to assess actual help seeking behavior. It is asked if participants have ever sought services from any professional and if they have been in therapy or received medical treatment because of psychological or physical health problems. As well as if they are using any of these services currently. Items are binary (yes, no).
measure: 12-Item Short-Form Health Survey (SF-12)
time frame: Baseline
description: Self-report measure of health related quality of life; norm-based scores (M=50, SD=10) for Physical Component Summary (PCS) and Mental Component Summary (MCS), higher score indicates better health state
measure: Patient Health Questionnaire (PHQ)
time frame: Baseline
description: Self-report inventory used to screen for mental health disorders (depression, anxiety, alcohol, eating, somatoform disorders), including severity scores for depressive symptoms (0-29), anxiety symptoms (0-21) and somatic symptoms (0-30), where higher scores indicate more serve symptoms
measure: Beck Depression Inventory-II (BDI-II)
time frame: Baseline
description: Self-report measure of depressed mood; higher total scores indicate more servere symptoms; total score (0-63); cut-offs for interpretation 0-13 (minimal depression), 14-19 (mild depression), 20-28 (moderate depression), 29-63 (severe depression)
measure: Public Stigma
time frame: Baseline
description: Measuring public stigma including stereotype (cognition - warmth, competence), prejudice (emotions - pity, envy, contempt, admiration) and discrimination (behavior - active/passive harm) with 19 items based on Stereotype Content Model (Fiske et al., 2002) and BIAS Map (Cuddy et al., 2007) toward people with mental or physical health problems.
(e.g. "How often do you think people in general tend to feel the following emotions toward people with a mental disorder? [pity, contempt, envy, admiration]")
measure: Expected Stigma
time frame: Baseline and 4 weeks
description: Expectation to be stigmatized because of one's own mental and physical health condition.
(e.g. "Do you expect that other people think badly of you because of your health condition?")
arm group label: healthy
description: Healthy participants
arm group label: mentally ill
description: Participants with mental disorders
arm group label: physically ill
description: Participants with organic disease
arm group label: mentally and physically ill
description: Participants with mental disorders and organic disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Mental Disorders
sharing ipd: Undecided