German Clinical Trials Register

Acronym/abbreviation of the study

STIGDERM

URL of the study

No Entry

Brief summary in lay language

Patients with skin diseases may have substantial psychosocial comorbidity and reduced quality of life. The study aims at exploring further the psychosocial burden of skin disease by assessing stigmatization experience and body image problems in a large sample of dermatological patients across Europe. This study aims at filling the lack of data on the experience of stigmatization in patients with common skin diseases and will expand our knowledge of body dysmorphic disorder in dermatological patients across Europe. Being a multicentre study conducted in 16 countries across Europe, this study will enable to understand cultural aspects of stigmatization and body dysmorphic concern in patients with skin disease. The study is a multicentre study across 16 European countries of prevalent cases of skin disease compared to controls. Consecutive patients will be recruited in dermatological out-patient clinics and complete questionnaires prior to clinical examination by a dermatologist at each recruitment site. The recruitment of 125 controls at each centre will be done by announcement in the hospital institution. Eligible patients and controls must be 18 years old or more and competent to read and write the language of the questionnaire. As for controls, people with a skin condition under treatment will be excluded. Clinical assessment (only for patients) The dermatologist will evaluate and record the diagnose for each condition. The severity will be assessed as “mild”, “moderate” or “severe”. The presence of treated co-morbidities will be recorded. Clinicians will also be required to answer questions on whether signs of psychological burden are present in the patient. Assessment (only for controls) Self-reported statement about presence of treated co-morbidities Self-reported measures (both groups) - demographic and health information (sex, age, marital status and employment status, weight and height, presence of itch and its characteristics, suicidal ideation; Patients only: severity of their skin condition, age of onset and localization of the skin disease. - Mood disorders (anxiety and depression) - Self-reported Health State - Feelings of Stigmatization - Perceived Stress - Body image concern Results will influence support intervention and management of patients with skin disease across Europe.

Brief summary in scientific language

Objectives The primary objective of the present study is to describe the psychosocial burden of skin diseases in different cultures by assessing Stigmatisation of patients with skin disease and secondly by estimating the prevalence of body image disorder in dermatological patients. Study design An observational cross-sectional multi-centre study of prevalent cases of skin diseases and skin healthy controls will be organised and conducted by members of the European Society for Dermatology and Psychiatry (ESDaP). Recruitment Cases: At the dermatological out-patient clinic at each centre in each participating country, consecutive patients will be invited to participate in the study on one or more random days until the required number of 250 respondents is reached. All patients will be fully briefed by a research assistant and will be accepted onto the study by signing a written consent form. Each patient will be examined by a dermatologist who will record the diagnosis; and, if required any secondary diagnosis will be recorded. Control group: A control group of 125 subjects total for each centre will be included , recruited by announcement. Inclusion criteria Eligible patients must meet the following inclusion criteria (both cases and controls): -Over 18 years of age -Competent to read and write the language of the questionnaire Exclusion criteria Controls with a skin condition under treatment Informed consent Informed consent will be obtained from relevant nursing staff or the research assistant from patients and controls. Clinical assessment of patients The dermatologist making the diagnosis will evaluate and record each condition as “mild”, “moderate” or “severe”. The presence of other conditions including the following treated co-morbidities will be recorded (cardio-vascular disease, chronic respiratory disease, diabetes, rheumatologic disease, other diseases). Clinicians will also be required to answer questions on whether signs of depression, anxiety and feelings of dysmorphic concern are present in the patient. Self-reported measures Each patient and control will complete some questionnaires and give it to the physician at the consultation. Background information questionnaire filled in by patients and controls will give information on: Socio demographic background, employment status, weight/height, itch: presence and characteristics, suicidal ideation: presence and frequency, (only controls: comorbidities under treatment, only patients: severity of condition (“mild”, “moderate”, “severe”), age of onset of skin disease, localization of the disease The Patient Health Questionnaire PHQ-2: a validated questionnaire to assess depression The General Anxiety Disorder Assessment GAD-2: a validated instrument to assess anxiety Self-reported Health State: EQ5D-VAS Perceived Stigmatisation Questionnaire PSQ to assess perceived stigmatization Dysmorphic Concern Questionnaire DCQ to assess body image concern Perceived Stress Scale PSS: 10 items assessing stress. With this study we will expand the knowledge on the psychosocial burden of common skin diseases in patients in different countries in Europe and specifically address the burden of stigmatisation and discrimination of patients with dermatological disorders We will expand and enhance our understanding of body dysmorphic disease, its prevalence and its relation to mental health problems. We expect higher values in the PSQ for dermatological patients in comparisson to skin healthy controls We expect higher prevalence of body dysmorphic disorder in dermatological conditions compared to controls We expect high correlations between stigmatisation experience and suicidal ideation in dermatological patients We expect differences in Stigmatisation according to dermatological disorders and severity We want to explore the relationship between mental distress and Stigmatisation experience among dermatological patients and controls