Digital Strategies for Patients With Chronic Dermatosis With Pruritus / Skin Picking Disorder
1 other identifier
interventional
163
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2021
CompletedNovember 30, 2021
November 1, 2021
6 months
January 22, 2021
November 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
6 months and 12 months
Secondary Outcomes (3)
Change in patient health questionnaire (PHQ-9)
6 months and 12 months
Change in General Anxiety Disorder-7 (GAD-7)
6 months and 12 months
Change in Dermatology Life Quality Index (DLQI)
6 months and 12 months
Study Arms (2)
internet CBT
EXPERIMENTALIntervention with remote and self-applicable cognitive behavioral therapy, during 4 weeks.
Quality of life promotion
ACTIVE COMPARATORControl intervention, during 4 weeks.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Dementias
- Acute psychotic disorder, bipolar disorder in acute episode, psychoactive substance use disorder (except tobacco), severe depressive episode or suicidal ideation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.035-903, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 22, 2021
First Posted
February 1, 2021
Study Start
February 1, 2021
Primary Completion
August 1, 2021
Study Completion
November 28, 2021
Last Updated
November 30, 2021
Record last verified: 2021-11