Mental DisorderNCT04415437
Self-Stigma of Mental and Physical Health
An observational study of Mental Disorder and Organic Disease, run by Philipps University Marburg at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Organic Disease
- How many people
- 823 participants
- Where
- 1 siteGermany
- Study dates
- 4 Nov 2019to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Random sample including students, outpatients, inpatients
Who may be able to join
- Minimum Age: 18
- Fluent in German Language
Who cannot join
- Acute psychosis
- Suicidal ideation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
Marburg, 35032
About this study
Official title: 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.
Read the 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).
- Conditions
- Mental Disorder, Organic Disease
- Keywords
- Self-Stigma, Mental Health, Physical Health, Questionnaire
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Development of the Universal Self-Stigma Scale (USSS)
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).
Measured: Baseline
Universal Self-Stigma Scale (USSS): Validity
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].
Measured: Baseline
Universal Self-Stigma Scale (USSS): Internal consistency
Internal consistency is tested with Cronbach's Alpha (0-1; higher scores indicate better internal consistency)
Measured: Baseline
Change on Universal Self-Stigma Scale (USSS): Test-Retest Reliability
Test-Retest Reliability (Pearson Correlation, 0-1; higher scores indicate better reliability)
Measured: Baseline and 4 weeks
Secondary outcomes (7)
Intention to Seek Help
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).
Measured: Baseline
Actual Help Seeking Behavior
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).
Measured: Baseline and 4 weeks
12-Item Short-Form Health Survey (SF-12)
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
Measured: Baseline
Patient Health Questionnaire (PHQ)
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
Measured: Baseline
Beck Depression Inventory-II (BDI-II)
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)
Measured: Baseline
Public Stigma
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]")
Measured: Baseline
Expected Stigma
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?")
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start4 Nov 2019
- Primary completion30 Jun 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 823 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415437
- Sponsor's protocol ID
- 2019-53k
- Status last verified
- Sep 2021
- First submitted
- 6 May 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Stigma of Mental and Physical Health: Developing and Validation of a Universal Self-Stigma Scale (USSS)
- ClinicalTrials.gov ID
- NCT04415437
- Acronym / sponsor ID
- 2019-53k
- Conditions
- Mental Disorder, Organic Disease
- Keywords
- Self-Stigma, Mental Health, Physical Health, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 823 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Random sample including students, outpatients, inpatients
Key inclusion criteria (2 listed)
- Minimum Age: 18
- Fluent in German Language
Key exclusion criteria (2 listed)
- Acute psychosis
- Suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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].
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)
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)
7 secondary outcomes
Intention to Seek Help
Time frame: Baseline
Actual Help Seeking Behavior
Time frame: Baseline and 4 weeks
12-Item Short-Form Health Survey (SF-12)
Time frame: Baseline
Patient Health Questionnaire (PHQ)
Time frame: Baseline
Beck Depression Inventory-II (BDI-II)
Time frame: Baseline
Public Stigma
Time frame: Baseline
Expected Stigma
Time frame: Baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Mental Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorder and Organic Disease, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of the Universal Self-Stigma Scale (USSS) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.