NCT04415437

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
823

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

May 6, 2020

Last Update Submit

September 14, 2021

Conditions

Keywords

Self-StigmaMental HealthPhysical HealthQuestionnaire

Outcome Measures

Primary Outcomes (4)

  • 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).

    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 \[higher correlations indicate better criterion validity\].

    Baseline

  • Universal Self-Stigma Scale (USSS): Internal consistency

    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

    Test-Retest Reliability (Pearson Correlation, 0-1; higher scores indicate better reliability)

    Baseline and 4 weeks

Secondary Outcomes (7)

  • Intention to Seek Help

    Baseline

  • Actual Help Seeking Behavior

    Baseline and 4 weeks

  • 12-Item Short-Form Health Survey (SF-12)

    Baseline

  • Patient Health Questionnaire (PHQ)

    Baseline

  • Beck Depression Inventory-II (BDI-II)

    Baseline

  • +2 more secondary outcomes

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Random sample including students, outpatients, inpatients

You may qualify if:

  • Minimum Age: 18
  • Fluent in German Language

You may not qualify if:

  • Acute psychosis
  • Suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

Marburg, 35032, Germany

Location

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

June 4, 2020

Study Start

November 4, 2019

Primary Completion

June 30, 2020

Study Completion

July 30, 2020

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations