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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05805696
Other study ID # 2022-01511-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 15, 2024
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Umeå University
Contact Elisabet Nylander, MD, PhD
Phone +46907859191
Email elisabet.nylander@umu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate persons/patients with different skin diseases or pain to evaluate whether unhealthy perfectionism, stress, anxiety, impostor phenomenon (inability to realistically assess your competence and skills) and lack of self-compassion (a positive attitude towards ourselves), have impact on symptoms, handling, and treatment regarding some dermatological diseases/pain.


Description:

The investigators have noticed that these conditions are common among patients attending the clinic. The investigators therefore want to do mapping of the occurrence and make an intervention to be able to change and evaluate handling of these patients. The hypothesis is that there is a connection between these conditions and that they are all part of the patientsĀ“ disease. The study will be done by using validated questionnaires which are answered anonymously using a code, that is known only by the participant, and with exercises/interventions for five or ten weeks. The questionnaires and interventions are formerly used in several international studies and by the investigators in populations of healthy persons with different professions. Examples of diseases is localised provoked vulvodynia (former vulvar vestibulitis) a state of pain that mainly affects young women. The symptoms are localized to the vulvar vestibulum and provoked by touch and experienced by the patient as pain or burning. The aetiology is not clearly known but probably due to both physical and psychological factors. Treatment is due to several strategies like treating the pain, rehabilitation of the perineum, and psychosocial support. Persons with this type of pain will also answer a short questionnaire regarding their symptoms. Another example is hyperhidrosis is excessive sweating without known cause. Hyperhidrosis may be primary focal or multifocal with debut in childhood. Secondary hyperhidrosis is often due to another disease. Hyperhidrosis often means big stress on mental health but may also affect physical functions. Persons with hyperhidrosis estimate their quality of life equal with those affected by severe acne or psoriasis. The investigatorsĀ“ ongoing research with mapping of these different traits of character shows that the occurrence is increasing, but no treatment has so far been available in Sweden. The investigators therefore want to evaluate whether treatment by intervention with one or two exercises each week may diminish the occurrence of impostor phenomenon and to be able to influence the disease. The questionnaires that will be used are "Self-Compassion scale short version" (SCS-SF), "Clance Impostor Phenomenon scale" (CIPS), "Perceived Stress scale 4" (PSS-4), "Generalized Anxiety Disorder-2" (GAD-2), and "Clinical Perfectionism Questionnaire short form" (CPQ-SF). These questionnaires are validated by other investigators and used in several international research studies. The questionnaires have already been translated from English to Swedish, except CIPS that has been translated and back-translated. There will also be questions on gender, age, and term. The software for statistical analyses is Statistical Package for the Social Sciences (SPSS) version 27 from International Business Machines Corporation (IBM). Before starting treatment, the participants will get a web-based survey including twenty questions about impostor phenomenon (CIPS), six questions about stress and anxiety (PSS-4 and GAD-2), twelve questions about self-compassion (SCS-SF) and six questions about perfectionism (CPQ-SF). The questionnaires are repeated week twelve and 24 after intervention. After inclusion and answering the first questionnaire the persons are asked to participate in a series of one or two interventions, 30 minutes each, every week for ten or five weeks respectively.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria - Patients attending the Dept of Dermatology and Venereology - Diagnosed with a dermatological disease Exclusion criteria - Age under 18 - Not able to read/speak Swedish

Study Design


Intervention

Behavioral:
Impostor tasks
Tasks to do every week

Locations

Country Name City State
Sweden Umea University Umea
Sweden Dept of Public Health and Clinical Medicine, Umeå University Umeå

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Signs of impostor Questionnaire regarding impostor At the beginning, after 12 and 24 weeks
Primary Signs of disease/pain Questionnaire regarding symptoms At the beginning, after 12 and 24 weeks
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