Self-Stigma of Mental and Physical Health

September 14, 2021 updated by: Philipps University Marburg Medical Center

Self-Stigma of Mental and Physical Health: Developing and Validation of a Universal Self-Stigma Scale (USSS)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
823

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Marburg, Germany, 35032
        • Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Random sample including students, outpatients, inpatients

Description

Inclusion Criteria:

  • Minimum Age: 18
  • Fluent in German Language

Exclusion Criteria:

  • Acute psychosis
  • Suicidal ideation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
healthy
Healthy participants
mentally ill
Participants with mental disorders
physically ill
Participants with organic disease
mentally and physically ill
Participants with mental disorders and organic disease

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Development of the Universal Self-Stigma Scale (USSS)
Time Frame: Baseline

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).
Baseline
Universal Self-Stigma Scale (USSS): Validity
Time Frame: Baseline
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].
Baseline
Universal Self-Stigma Scale (USSS): Internal consistency
Time Frame: Baseline
Internal consistency is tested with Cronbach's Alpha (0-1; higher scores indicate better internal consistency)
Baseline
Change on Universal Self-Stigma Scale (USSS): Test-Retest Reliability
Time Frame: Baseline and 4 weeks
Test-Retest Reliability (Pearson Correlation, 0-1; higher scores indicate better reliability)
Baseline and 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intention to Seek Help
Time Frame: Baseline
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).
Baseline
Actual Help Seeking Behavior
Time Frame: Baseline and 4 weeks
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).
Baseline and 4 weeks
12-Item Short-Form Health Survey (SF-12)
Time Frame: Baseline
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
Baseline
Patient Health Questionnaire (PHQ)
Time Frame: Baseline
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
Baseline
Beck Depression Inventory-II (BDI-II)
Time Frame: Baseline
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)
Baseline
Public Stigma
Time Frame: Baseline

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]")
Baseline
Expected Stigma
Time Frame: Baseline and 4 weeks

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?")
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philipps University Marburg Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-53k

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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