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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Brazil

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.

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 groups in NCT04731389
Study groupRoleWhat they receive
internet CBTExperimentalIntervention with remote and self-applicable cognitive behavioral therapy, during 4 weeks.
Receives: Behavioral: internet-based cognitive-behavioral therapy
Quality of life promotionActive comparatorControl 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted1 Feb 2021
  2. Study start1 Feb 2021
  3. Primary completion1 Aug 2021
  4. Study completion28 Nov 2021

Resources

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)
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

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.

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