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Psoriasis is a chronic inflammatory disease that is often associated with a number of somatic and mental comorbidity. Patients with psoriasis show an increased risk of depression and (social) anxiety.
The aims of this study are 1) to explore the psychosocial distress of patients with psoriasis and to assess their care needs; and 2) to develop a supportive intervention based on the prior results.
A multi-stage design with four phases combining quantitative and qualitative methodology will be used and conducted in two centers. 1) A scoping review and focus groups will be used to design a questionnaire to assess the psychosocial distress and care needs of the patients. 2) The questionnaire developed in phase 1 will be used in a cross-sectional survey to assess the extent of psychosocial distress and supportive care needs in 400 patients with psoriasis. 3) A systematic review and meta-analysis will be conducted to identify psychosocial and psychoeducational interventions for patients with psoriasis and to describe their effectiveness. 4) Based on the results of the phases 2 and 3 a manualized supportive intervention will be developed and the feasibility and acceptance of the intervention will be assessed.
Currently, phase 1 of the project has been completed and the recruitment for phase 2 has been started. The systematic review and meta-analysis of phase 3 are conducted simultaneously to phase 2 and results are expected soon. Phase 4 has not been started yet.
The expected results of this study will show the extent of psychosocial distress of patients with psoriasis in Germany and supplement previous research with findings about the supportive care needs of this patient group. Moreover, the developed intervention will help to address the psychosocial support needs of patients with psoriasis. Research shows that psychosocial support is strongly needed.
Psoriasis is one of the most common chronic inflammatory skin diseases with a prevalence of 1 to 3 % in western industrial countries. In Germany about 2 million patients are affected [
Reasons for the psychosocial burden of patients with psoriasis are experienced stigmatization in social situations, the workplace, difficulties with body image, self-esteem, and self-concept [
Research suggests that psychosocial stress is not just a consequence of psoriasis but can also be involved in the exacerbation of the symptoms [
For these reasons, current concepts of psoriasis management include screening for mental comorbidity and recommend interdisciplinary teamwork and psychosocial support if applicable [
Until now, different reviews subsumed studies on the effects of psychosocial interventions on psoriasis patients. Larsen et al [
To assess the psychosocial distress of patients with psoriasis
To investigate their needs for information and psychosocial support
To develop a psychosocial intervention to educate and support psoriasis patients
To test the feasibility, acceptance and effectiveness of this intervention
A multi-stage design with four phases combining quantitative and qualitative methodology will be conducted. It is displayed in
The project will be carried out at Department of Medical Psychology in cooperation with the Institute for Health Services Research in Dermatology and Nursing at the University Medical Center Hamburg-Eppendorf and the Psoriasis Center at the Department of Dermatology of the University Medical Center Schleswig-Holstein Campus Kiel in Germany.
Flow-chart of study phases.
A scoping review [
Based on the results of the scoping review a complete questionnaire will be developed to assess the psychosocial burden of psoriasis patients. Following, two focus groups with n=10 patients with psoriasis in each focus group will be conducted to validate and complement the results of the scoping review.
The patients will be consecutively recruited during consultations at the Psoriasis Centers of University Medical Center Schleswig-Holstein Campus Kiel and Institute for Health Services Research in Dermatology and Nursing of the University Medical Center Hamburg.
Adult patients (age ≥ 18) will be included. Patients need to be diagnosed with a mild, moderate, or severe psoriasis and need to agree by signing informed consent. Inclusion criteria will be checked from the treating physician, who will also fulfill a short questionnaire on the patients’ clinical data (severity of the psoriasis, presence of psoriasis arthritis or other comorbidity).
One focus group will be conducted at the Psoriasis Center in Kiel and the second at the Department of Medical Psychology in Hamburg. Each focus group is planned to take 120 minutes and patients will receive 50€ for their participation. The main issue of the discussion will be to critically review the developed questionnaire in terms of feasibility and understanding with the patients and to add missing topics regarding information and supportive care needs.
The focus groups will be recorded and transcribed. The results will show if any adaption of the questionnaire will be necessary or if further items should be developed and included based on the feedback of the patients. The final questionnaire will then be used in a quantitative survey in phase 2.
The questionnaire developed in phase 1 will be used in a cross-sectional survey to assess the extent of psychosocial distress and supportive care needs in patients with psoriasis.
Participants for phase 2 will be recruited again through consecutive consultations in the two cooperating dermatology centers.
Survey flow-chart for the questionnaire. Calculated with an expected return rate of 40%.
The inclusion criteria are the same as for phase 1.
A sample size of N=400 is projected (
Based on the results of the scoping review in phase 1 we expect to include measures on mental disorders, quality of life, psychosocial distress, health and risk behaviors, information needs and utilization of supportive interventions, needs for supportive care, empowerment, and resources of psoriasis patients. Moreover, sociodemographic data will be assessed. The health status in terms of psoriasis severity and comorbidity will be rated by the treating physician.
The primary analyses for phase 2 will be descriptive (percentages, means, and standard deviations). The results of this phase will inform the focus of the treatment elements contained within the intervention.
To identify which psychosocial and psychoeducational interventions for patients with psoriasis already exist and which are effective, a systematic review will be conducted. The methods and results will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [
Data will be systematically extracted from the included references on the study population, details of the intervention and the outcomes. Furthermore, the risk of bias will be rated for all controlled trials by two independent reviewers according to the Cochrane Handbook for Systematic Reviews of Interventions [
For the most relevant patient-reported outcomes a meta-analysis will be performed on all controlled trials that assessed these outcomes. Primary outcome will be HrQoL. Additional outcomes will be chosen depending on whether there will be enough data for a meta-analysis. Furthermore, if the data allows it, subgroup analysis on HrQoL will be performed to compare different aspects of the interventions in their effectiveness.
Based on the results of the phases 2 and 3 a supportive intervention will be developed.
Based on the needs assessment and the meta-analyses an intervention will be developed addressing the needs of the patients with the most promising intervention type, which can be face-to-face in a group or single setting or an internet-based approach. Internet-based interventions may reach larger parts of the patient population and allow a high degree of flexibility. Existing Internet-based programs (eg, for depression, alcohol consumption, or stress reduction) could be adapted for these patients or certain modules could be tailored [
We plan to use qualitative methods to explore how professionals and people with psoriasis view the draft of the intervention. In the first step, a focus group with 6 health care professionals (four dermatologists and two psychologists) and 2 patient representatives (eg, of the “Deutscher Psoriasis Bund e.V.” [
In the second step, n=8 patients with psoriasis will be sought using convenience sampling recruited from the participating clinics. Think aloud methodology [
When the manual for the intervention is finally developed, the feasibility of the intervention will be assessed. The primary aim of this feasibility assessment will be to examine the potential of the intervention to cause clinical relevant changes on the patient’s side and to identify the methodological requirements for a future trial.
Therefore, if it suits the intervention type, the study aims to recruit a sample of approximately 30 participants. These participants will be randomized into an intervention group and a control group (
The group means and standard deviations for the intervention group and control group before and after the intervention will be presented. In addition, inferential comparisons between both groups will be calculated. Yet due to the small population of the pilot study we do not expect to have enough power to reliably detect meaningful differences.
Survey flow-chart for the intervention.
At the current state of the project the questionnaire development of phase 1 has been completed. The recruitment for the quantitative survey of phase 2 has been started and to date (19 of September 2017) n=185 patients have been included. The systematic review and meta-analysis of phase 3 are conducted simultaneously to phase 2 and results are expected to be completed soon. Phase 4 has not been started yet.
Previous research showed that patients with psoriasis are likely to suffer from psychosocial distress and various somatic and mental comorbidities [
The described study will respond to the necessity of focusing on the psychosocial burden of this patient group in a multi-center project combining qualitative and quantitative methodologies. In four phases, relevant research questions will be addressed to close current research gaps. In the first phase an extensive questionnaire development will be conducted. This includes a scoping review on measures on psychosocial distress and information and supportive care needs as well as discussions on the questionnaire with patients in focus groups that will result in a comprehensive and validated questionnaire. In the second phase with the quantitative survey using the questionnaire developed in the prior phase data on the psychosocial distress and information and supportive care needs of patients from two psoriasis centers in Germany will be gained. Moreover, the pre-test of a screening measure will help to develop an instrument to screen for patients with support needs in future consultations.
In the third phase, a meta-analysis will be conducted that adds on prior systematic reviews by summarizing the effectiveness of previous studies on psychosocial/psychoeducative interventions for psoriasis patients. Up-to date, to our knowledge no systematic review including all psychosocial/psychoeducative interventions on psoriasis exists. Effects of these interventions have not been shown in a meta-analysis yet.
In the final phase, the results of the prior phases will be used for the development of psychosocial interventions that is tailored to the specific needs of this patient group. It is hoped that due to the comprehensive knowledge gained from the survey and the expert and patient focus groups the intervention will be found as effective.
The expected benefits from this study are to find out about the psychosocial support needs of patients with psoriasis and to add on previous research on patients’ goals in psoriasis treatment. Blome et al found that besides skin treatment related goals of psoriasis patients, like “to be healed of all skin defects,“ goals like “to be comfortable showing yourself more in public,” “to be able to have more contact with other people” or “to be more productive in everyday life,” are from high relevance for the patients [
Alcohol Use Disorders Identification Test
Cochrane Central Register of Controlled Trials
Generalized Anxiety Disorder 7
health-related quality of life
Patient Health Questionnaire
Preferred Reporting Items for Systematic Reviews and Meta-Analyses
psoriatic arthritis
randomized controlled trials
Somatic Symptom Disorder
This project was funded by Lilly Deutschland GmbH, Germany by an unrestricted educational grant. Lilly Deutschland GmbH played no role in the execution of this study or in data collection, data management, and data analysis, interpretation of the data, decision to publish, manuscript preparation, manuscript review, or manuscript approval.
The study is being conducted in compliance with the Declaration of Helsinki [
We would like to thank Janine Topp, and Sarah Fabel for their work on the project as student research assistants.
UM, MA and MH declare financial interests with the project funder Lilly Deutschland GmbH. Lilly Deutschland GmbH provided support in the form of salaries for authors JZ, JD, and EC. The other authors do not declare any competing interests.
JD, SD, UM, MH and MA are responsible for the overall design of the study. JZ has drafted the manuscript. MH and JD are the principal investigators of the study. UM and MA are the responsible investigators at the cooperating institutes: the Institute for Health Services Research in Dermatology and Nursing at the University Medical Center Hamburg-Eppendorf and the Psoriasis Center at the Department of Dermatology of the University Medical Center Schleswig-Holstein Campus Kiel in Germany. EC supported with the methods and design of the study. All authors have read and approved the final manuscript.