Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Digital Strategies for Patients With Chronic Dermatosis With Pruritus / Skin Picking Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04731389
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Carolina Blaya Dreher, Hospital de Clinicas de Porto Alegre

Brief 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.

Condition or disease Intervention/treatment Phase
Skin-Picking Acne Dermatosis Behavioral: internet-based cognitive-behavioral therapy Behavioral: Quality of life improving intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Digital Strategies for Patients With Chronic Dermatosis With Pruritus / Skin Picking Disorder
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: internet CBT
Intervention with remote and self-applicable cognitive behavioral therapy, during 4 weeks.
Behavioral: internet-based cognitive-behavioral therapy
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.
Other Name: Active intervention group

Active Comparator: Quality of life promotion
Control intervention, during 4 weeks.
Behavioral: Quality of life improving intervention
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.
Other Name: Active control group




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in patient health questionnaire (PHQ-9) [ Time Frame: 6 months and 12 months ]
    Improvement in depression assessed by the PHQ-9 scale. The scale scores vary from 0-27, with higher scores meaning more severe symptoms.

  2. Change in General Anxiety Disorder-7 (GAD-7) [ Time Frame: 6 months and 12 months ]
    Improvement in anxiety assessed by the GAD-7 scale. The scale scores vary from 0-21, with higher scores meaning more severe symptoms.

  3. Change in Dermatology Life Quality Index (DLQI) [ Time Frame: 6 months and 12 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Dementias
  • Acute psychotic disorder, bipolar disorder in acute episode, psychoactive substance use disorder (except tobacco), severe depressive episode or suicidal ideation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04731389


Contacts
Layout table for location contacts
Contact: carolina Blaya Dreher, MD MSc PhD +555133598294 cdreher@hcpa.edu.br
Contact: Alice C. M. Xavier, MD MSc +5551992664409 acmxavier@hcpa.edu.br

Locations
Layout table for location information
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90.035-903
Contact: Carolina Blaya Dreher, MD MSc PhD    +55 51 33334078    cdreher@hcpa.edu.br   
Contact: Alice C. M. Xavier, MD MSc    +5551992664409    acmxavier@hcpa.edu.br   
Sub-Investigator: Clarissa Prati, MD MSc PhD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Layout table for additonal information
Responsible Party: Carolina Blaya Dreher, Professor, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT04731389    
Other Study ID Numbers: 37827820.6.0000.5327
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolina Blaya Dreher, Hospital de Clinicas de Porto Alegre:
skin picking
cognitive-behavioral therapy
internet-based therapy
psychodermatosis
acne
Additional relevant MeSH terms:
Layout table for MeSH terms
Pruritus
Skin Diseases
Skin Manifestations