DermatosesNCT05805696
Treatment and Mapping of Impostor Phenomenon
A study testing Impostor tasks in people with Dermatoses and Vestibulodynia, run by Umeå University at 2 sites in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatoses, Vestibulodynia, Hyperhidrosis
- What is being tested?
- Impostor tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSweden
- Study dates
- 15 May 2024to 31 Dec 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients attending the Dept of Dermatology and Venereology
- Diagnosed with a dermatological disease
Who cannot join
- Age under 18
- Not able to read/speak Swedish
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 1 recruiting
- Recruiting
Umea University
Umeå, 90185
Elisabet Nylander, MD, PhD, 702668528, elisabet.nylander@umu.se
Jens Boman, MD,PhD, 767772650
- Active, not recruiting
Dept of Public Health and Clinical Medicine, Umeå University
Umeå, 90186
About this study
Official title: Treatment and Mapping of Self-compassion, Perfectionism, Stress, Anxiety and Impostor Phenomenon in Patients With Different Dermatological Diseases and Pain
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.
Read the detailed 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 patients´ 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 investigators´ 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.
- Conditions
- Dermatoses, Vestibulodynia, Hyperhidrosis, Pain Syndrome
- Being tested
- Impostor tasks
- Medical subject headings
- Skin Diseases, Vulvodynia, Hyperhidrosis, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impostor tasksBehavioural
Tasks to do every week
| Study group | Role | What they receive |
|---|---|---|
| Treatment for five weeks | Experimental | The patients will get questionnaires before and 12 weeks and 24 weeks after intervention. The intervention will last for 5 weeks. Receives: Behavioral: Impostor tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs of impostor
Questionnaire regarding impostor
Measured: At the beginning, after 12 and 24 weeks
Signs of disease/pain
Questionnaire regarding symptoms
Measured: At the beginning, after 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start15 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatosesStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will get the same questionnaires and the same intervention
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabet Nylander, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805696
- Sponsor's protocol ID
- 2022-01511-01
- Status last verified
- May 2024
- First submitted
- 9 Mar 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Mapping of Self-compassion, Perfectionism, Stress, Anxiety and Impostor Phenomenon in Patients With Different Dermatological Diseases and Pain
- ClinicalTrials.gov ID
- NCT05805696
- Acronym / sponsor ID
- 2022-01511-01
- Conditions
- Dermatoses, Vestibulodynia, Hyperhidrosis, Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Apr 2023 (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.
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.
Detailed 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 patients´ 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 investigators´ 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will get the same questionnaires and the same intervention
| Arm | Type | Receives |
|---|---|---|
| Treatment for five weeks | Experimental | Behavioral: Impostor tasksThe patients will get questionnaires before and 12 weeks and 24 weeks after intervention. The intervention will last for 5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients attending the Dept of Dermatology and Venereology
- Diagnosed with a dermatological disease
Key exclusion criteria (2 listed)
- Age under 18
- Not able to read/speak Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impostor tasksTasks to do every week | Behavioural | Treatment for five weeks |
Primary outcome
Signs of impostor
Time frame: At the beginning, after 12 and 24 weeks
Questionnaire regarding impostor
Signs of disease/pain
Time frame: At the beginning, after 12 and 24 weeks
Questionnaire regarding symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impostor tasks in people with Dermatoses and Vestibulodynia, run by Umeå University at 2 sites in Sweden.
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: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabet Nylander, MD, PhD (+46907859191, elisabet.nylander@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signs of impostor (time frame: At the beginning, after 12 and 24 weeks). The study lists 2 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 10 May 2024.