NCT04731389

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2021

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

January 22, 2021

Last Update Submit

November 28, 2021

Conditions

Keywords

skin pickingcognitive-behavioral therapyinternet-based therapypsychodermatosisacne

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

EXPERIMENTAL

Intervention with remote and self-applicable cognitive behavioral therapy, during 4 weeks.

Behavioral: internet-based cognitive-behavioral therapy

Quality of life promotion

ACTIVE COMPARATOR

Control intervention, during 4 weeks.

Behavioral: Quality of life improving intervention

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.

Also known as: Active intervention group
internet CBT

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.

Also known as: Active control group
Quality of life promotion

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Excoriation DisorderAcne VulgarisSkin Diseases

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorObsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct DisordersAcneiform EruptionsSkin and Connective Tissue DiseasesSebaceous Gland Diseases

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

Locations