Digital Strategies for Patients With Chronic Dermatosis With Pruritus / Skin Picking Disorder
Primary Purpose
Skin-Picking, Acne, Dermatosis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
internet-based cognitive-behavioral therapy
Quality of life improving intervention
Sponsored by
About this trial
This is an interventional treatment trial for Skin-Picking focused on measuring skin picking, cognitive-behavioral therapy, internet-based therapy, psychodermatosis, acne
Eligibility 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
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
internet CBT
Quality of life promotion
Arm Description
Intervention with remote and self-applicable cognitive behavioral therapy, during 4 weeks.
Control intervention, during 4 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04731389
First Posted
January 22, 2021
Last Updated
November 28, 2021
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT04731389
Brief Title
Digital Strategies for Patients With Chronic Dermatosis With Pruritus / Skin Picking Disorder
Official Title
Digital Strategies for Patients With Chronic Dermatosis With Pruritus / Skin Picking Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
November 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin-Picking, Acne, Dermatosis
Keywords
skin picking, cognitive-behavioral therapy, internet-based therapy, psychodermatosis, acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
internet CBT
Arm Type
Experimental
Arm Description
Intervention with remote and self-applicable cognitive behavioral therapy, during 4 weeks.
Arm Title
Quality of life promotion
Arm Type
Active Comparator
Arm Description
Control intervention, during 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
internet-based cognitive-behavioral therapy
Other Intervention Name(s)
Active intervention group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Quality of life improving intervention
Other Intervention Name(s)
Active control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Skin Picking Scale Revised
Description
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.
Time Frame
6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in patient health questionnaire (PHQ-9)
Description
Improvement in depression assessed by the PHQ-9 scale. The scale scores vary from 0-27, with higher scores meaning more severe symptoms.
Time Frame
6 months and 12 months
Title
Change in General Anxiety Disorder-7 (GAD-7)
Description
Improvement in anxiety assessed by the GAD-7 scale. The scale scores vary from 0-21, with higher scores meaning more severe symptoms.
Time Frame
6 months and 12 months
Title
Change in Dermatology Life Quality Index (DLQI)
Description
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.
Time Frame
6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90.035-903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Digital Strategies for Patients With Chronic Dermatosis With Pruritus / Skin Picking Disorder
We'll reach out to this number within 24 hrs