Skin-PickingNCT04731389
Digital Strategies for Patients With Chronic Dermatosis With Pruritus / Skin Picking Disorder
A study testing internet-based cognitive-behavioral therapy and Quality of life improving intervention in people with Skin-Picking and Acne, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Almost 35% of patients treated to dermatosis have some psychiatric disorder. The aim of this study is to evaluate the prevalence and severity of skin picking disorder and other dermatosis, and also test the efficacy of an online-delivered cognitive-behavioral therapy to improve skin picking disorder severity. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Skin-Picking, Acne, Dermatosis
- What is being tested?
- internet-based cognitive-behavioral therapy and Quality of life improving intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2021to 28 Nov 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 years
- Internet access
- Diagnosis of Skin Picking (dermatillomania)
- Patients may be diagnosed or not with primary dermatoses, such as acne, atopic dermatitis, psoriasis and rosacea
Who cannot join
- Dementias
- Acute psychotic disorder, bipolar disorder in acute episode, psychoactive substance use disorder (except tobacco), severe depressive episode or suicidal ideation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.035-903
About this study
Almost 35% of patients treated to dermatosis have some psychiatric disorder. The aim of this study is to evaluate the prevalence and severity of skin picking disorder and other dermatosis, and also test the efficacy of an online-delivered cognitive-behavioral therapy to improve skin picking disorder severity.
Read the detailed description
The interface between dermatology and psychiatry represents a major challenge for the management of chronic itchy pathologies. Dermatology requires adherence to chronic treatments that must be incorporated as changes in habit. In addition, patients with chronic pruritic dermatoses often develop a scratching habit that often leads to the development of dermatillomania, requiring psychiatric intervention. In general, among the patients who seek the dermatologist, 33% complain of psychiatric symptoms. On the other hand, patients with psychiatric conditions have a higher prevalence of dermatoses when compared to the healthy population, with anxiety, depression and psychosis being situations that can induce or worsen dermatological conditions. Despite the important interface between dermatology and psychiatry, there is still a gap in the literature about the best way to diagnose and treat these patients affected by psychodermatosis, and also a lack of professionals' knowledge about this theme. One study addressed the quality of the treatments currently offered for skin picking, also known as dermatillomania, finding that only 53% of patients report having received the correct diagnosis of their pathology, and after the treatment offered, 54.7% of individuals reported that their clinical condition was unchanged or worse, and only 11% of patients reported feeling better with the treatment performed. When asked about the training of professionals, 85% of patients reported that the professional did not seem to have knowledge about his clinical condition.
The current world moment, in the face of the Covid-19 pandemic, keeps these patients away from possible interventions that could bring relief to the situation, either for fear of contamination, difficulties in displacement or even a temporary reduction in vacancies for care. The great and just effort of the Health Systems to face the pandemic can, on the other hand, impact the offer of assistance to chronic dermatological diseases. Around the world, telemedicine and other distance health care protocols have been used in an attempt to assist patients. But not all carriers of these chronic diseases are part of health systems. It is also known that during the COVID pandemic19, dermatoses frequently associated with dermatillomania are still the most common causes of consultations with dermatologists, such as acne and eczema. Changes in routine, especially food and physical activity, but also in certain habits, such as frequent hand hygiene and the use of astringent substances, such as alcohol gel, worsen or trigger inflammatory conditions. Still, the frequent use of masks induces the appearance of pruritus, which can increase the severity of already existing dermatoses and, also, lead to the misuse of props.
Thus, the investigators propose the development of an electronic website with educational strategies and self-applicable tools for cognitive behavioral therapy to patients with dermatoses who have pruritus or symptoms on the skin with the potential to develop or even with the diagnosis of skin picking. The website proposed here aims to help patients with chronic dermatoses seeking both the prevention and treatment of possible complications. This set of Internet pages aims to provide educational material, strategies to increase adherence to treatment and interventions with cognitive-behavioral therapy techniques, facilitating patients' autonomy in caring for their skin disorders, especially in times as troubled as the current one.
- Conditions
- Skin-Picking, Acne, Dermatosis
- Being tested
- internet-based cognitive-behavioral therapy, Quality of life improving intervention
- Keywords
- skin picking, cognitive-behavioral therapy, internet-based therapy, psychodermatosis, acne
- Medical subject headings
- Excoriation Disorder, Acne Vulgaris, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-based cognitive-behavioral therapyBehavioural
Also called Active intervention group
Composed of 4 modules: the first module will address psychoeducation on dermatillomania, self-monitoring of symptoms and habit reversal techniques; the second module works with anxiety coping techniques (diaphragmatic breathing and muscle relaxation); module 3 addresses cognitive correction techniques, such as stopping thinking, analyzing evidence, reassigning severity and responsibilities; the last module reviews the techniques learned and addresses techniques for preventing symptom relapse. The modules will be applied by the patient in an online format, each module lasts an average of 30 minutes. The platform will send notice by email through automation tools, SMS or message by application to patients to remind them to complete 1 module per week.
Quality of life improving interventionBehavioural
Also called Active control group
consisting of videos with guidance on quality of life, with a total of 4 videos of 2 minutes, each being made available in 1 week, consisting of: guidance on sleep hygiene; guidance on healthy eating; guidelines on the practice of physical activity and guidelines on the excessive use of social networks.
| Study group | Role | What they receive |
|---|---|---|
| internet CBT | Experimental | Intervention with remote and self-applicable cognitive behavioral therapy, during 4 weeks. Receives: Behavioral: internet-based cognitive-behavioral therapy |
| Quality of life promotion | Active comparator | Control intervention, during 4 weeks. Receives: Behavioral: Quality of life improving intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Picking Scale Revised
Improvement in the severity of dermatillomania assessed by the Skin Picking Scale Revised, adapted to the Brazilian population.The scale scores vary from 0-32, with higher scores meaning more severe symptoms.
Measured: 6 months and 12 months
Secondary outcomes (3)
Change in patient health questionnaire (PHQ-9)
Improvement in depression assessed by the PHQ-9 scale. The scale scores vary from 0-27, with higher scores meaning more severe symptoms.
Measured: 6 months and 12 months
Change in General Anxiety Disorder-7 (GAD-7)
Improvement in anxiety assessed by the GAD-7 scale. The scale scores vary from 0-21, with higher scores meaning more severe symptoms.
Measured: 6 months and 12 months
Change in Dermatology Life Quality Index (DLQI)
Improvement in quality of life related to skin assessed by DLQI scale. The scale scoring vary from 0-30, with higher scoring meaning more severe life impact.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Aug 2021
- Study completion28 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin-PickingStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Blaya Dreher, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731389
- Sponsor's protocol ID
- 37827820.6.0000.5327
- Status last verified
- Nov 2021
- First submitted
- 22 Jan 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Strategies for Patients With Chronic Dermatosis With Pruritus / Skin Picking Disorder
- ClinicalTrials.gov ID
- NCT04731389
- Acronym / sponsor ID
- 37827820.6.0000.5327
- Conditions
- Skin-Picking, Acne, Dermatosis
- Keywords
- skin picking, cognitive-behavioral therapy, internet-based therapy, psychodermatosis, acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 28 Nov 2021 (actual)
- First posted
- 1 Feb 2021 (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.
Almost 35% of patients treated to dermatosis have some psychiatric disorder. The aim of this study is to evaluate the prevalence and severity of skin picking disorder and other dermatosis, and also test the efficacy of an online-delivered cognitive-behavioral therapy to improve skin picking disorder severity.
Detailed description
The interface between dermatology and psychiatry represents a major challenge for the management of chronic itchy pathologies. Dermatology requires adherence to chronic treatments that must be incorporated as changes in habit. In addition, patients with chronic pruritic dermatoses often develop a scratching habit that often leads to the development of dermatillomania, requiring psychiatric intervention. In general, among the patients who seek the dermatologist, 33% complain of psychiatric symptoms. On the other hand, patients with psychiatric conditions have a higher prevalence of dermatoses when compared to the healthy population, with anxiety, depression and psychosis being situations that can induce or worsen dermatological conditions. Despite the important interface between dermatology and psychiatry, there is still a gap in the literature about the best way to diagnose and treat these patients affected by psychodermatosis, and also a lack of professionals' knowledge about this theme. One study addressed the quality of the treatments currently offered for skin picking, also known as dermatillomania, finding that only 53% of patients report having received the correct diagnosis of their pathology, and after the treatment offered, 54.7% of individuals reported that their clinical condition was unchanged or worse, and only 11% of patients reported feeling better with the treatment performed. When asked about the training of professionals, 85% of patients reported that the professional did not seem to have knowledge about his clinical condition.
The current world moment, in the face of the Covid-19 pandemic, keeps these patients away from possible interventions that could bring relief to the situation, either for fear of contamination, difficulties in displacement or even a temporary reduction in vacancies for care. The great and just effort of the Health Systems to face the pandemic can, on the other hand, impact the offer of assistance to chronic dermatological diseases. Around the world, telemedicine and other distance health care protocols have been used in an attempt to assist patients. But not all carriers of these chronic diseases are part of health systems. It is also known that during the COVID pandemic19, dermatoses frequently associated with dermatillomania are still the most common causes of consultations with dermatologists, such as acne and eczema. Changes in routine, especially food and physical activity, but also in certain habits, such as frequent hand hygiene and the use of astringent substances, such as alcohol gel, worsen or trigger inflammatory conditions. Still, the frequent use of masks induces the appearance of pruritus, which can increase the severity of already existing dermatoses and, also, lead to the misuse of props.
Thus, the investigators propose the development of an electronic website with educational strategies and self-applicable tools for cognitive behavioral therapy to patients with dermatoses who have pruritus or symptoms on the skin with the potential to develop or even with the diagnosis of skin picking. The website proposed here aims to help patients with chronic dermatoses seeking both the prevention and treatment of possible complications. This set of Internet pages aims to provide educational material, strategies to increase adherence to treatment and interventions with cognitive-behavioral therapy techniques, facilitating patients' autonomy in caring for their skin disorders, especially in times as troubled as the current one.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| internet CBT | Experimental | Behavioral: internet-based cognitive-behavioral therapyIntervention with remote and self-applicable cognitive behavioral therapy, during 4 weeks. |
| Quality of life promotion | Active comparator | Behavioral: Quality of life improving interventionControl intervention, during 4 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 years
- Internet access
- Diagnosis of Skin Picking (dermatillomania)
- Patients may be diagnosed or not with primary dermatoses, such as acne, atopic dermatitis, psoriasis and rosacea
Key exclusion criteria (2 listed)
- Dementias
- Acute psychotic disorder, bipolar disorder in acute episode, psychoactive substance use disorder (except tobacco), severe depressive episode or suicidal ideation
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 |
|---|---|---|
| internet-based cognitive-behavioral therapyAlso: Active intervention groupComposed of 4 modules: the first module will address psychoeducation on dermatillomania, self-monitoring of symptoms and habit reversal techniques; the second module works with anxiety coping techniques (diaphragmatic breathing and muscle relaxation); module 3 addresses cognitive correction techniques, such as stopping thinking, analyzing evidence, reassigning severity and responsibilities; the last module reviews the techniques learned and addresses techniques for preventing symptom relapse. The modules will be applied by the patient in an online format, each module lasts an average of 30 minutes. The platform will send notice by email through automation tools, SMS or message by application to patients to remind them to complete 1 module per week. | Behavioural | internet CBT |
| Quality of life improving interventionAlso: Active control groupconsisting of videos with guidance on quality of life, with a total of 4 videos of 2 minutes, each being made available in 1 week, consisting of: guidance on sleep hygiene; guidance on healthy eating; guidelines on the practice of physical activity and guidelines on the excessive use of social networks. | Behavioural | Quality of life promotion |
Primary outcome
Change in Skin Picking Scale Revised
Time frame: 6 months and 12 months
Improvement in the severity of dermatillomania assessed by the Skin Picking Scale Revised, adapted to the Brazilian population.The scale scores vary from 0-32, with higher scores meaning more severe symptoms.
3 secondary outcomes
Change in patient health questionnaire (PHQ-9)
Time frame: 6 months and 12 months
Change in General Anxiety Disorder-7 (GAD-7)
Time frame: 6 months and 12 months
Change in Dermatology Life Quality Index (DLQI)
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internet-based cognitive-behavioral therapy and Quality of life improving intervention in people with Skin-Picking and Acne, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 4 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: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Picking Scale Revised (time frame: 6 months and 12 months). 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 30 Nov 2021.