Impact of COVID-19 on Mental Health of Patients With Skin Picking

NCT04522492 | Completed DMC

• 1 other identifier: 31520820.1.0000.5327
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Skin Picking Disorder (SPD) affects up to 10% of the general population, causing significant socioeconomic damage in 75% of affected individuals. It is characterized by the repeated habit of touching the skin itself, causing or aggravating wounds, with difficulty in controlling the habit. It is associated with anxiety disorders in about 20% of cases and with depressive disorder in about 50%. Patients with SPD have difficulties in regulating emotions, being more vulnerable to having their mental symptoms aggravated in face of stressful situations, such as the current coronavirus-19 pandemia. Among the treatments available to SPD, cognitive behavioral therapy is the only intervention superior to placebo, and there is still no medication approved by the FDA indicated specifically to SPD. The effectiveness of cognitive behavioral therapy was assessed in a randomized clinical trial with Brazilian patients with SPD, but its long-term benefit has not yet been evaluated. Additionally, telemedicine interventions can be effective and used during pandemia, but the effectiveness of internet delivered cognitive behavioral therapy for SPD is not clear yet.

Conditions

Skin Picking

Outcome Measures

Primary Outcomes (1)

• Change in Global Clinical Impression Scale

  The skin picking improvement after intervention will be assessed by the change in the Global Clinical Impression Scale, applied by blinded evaluators.

  2 weeks

Secondary Outcomes (5)

• Change in Beck Anxiety Inventory

  2 weeks

• Change in Beck Depression Inventory

  2 weeks

• Change of Skin Picking Impact Scale

  2 weeks

• Change of emotional regulation

  2 weeks

• Change in Hamilton Anxiety Scale

  2 weeks

Study Arms (2)

internet CBT

EXPERIMENTAL

Internet delivered cognitive behavioral therapy, thru 2 booster sessions. Each session will last 50 minutes. Fist session will involve: psychoeducation about the symptoms, evaluation of the skin picking habit, reinforcement of the habit reversal strategies. After 1 week, the second session will be applied, consisting of: strategies to cope with anxiety (breathing and muscle relaxation techniques) and to cope with depressive status (cognitive restructuring techniques).

Behavioral: Internet-based Cognitive Behavioral Therapy

Quality of life promotion

ACTIVE COMPARATOR

The therapist will send to the patient 2 videos with strategies to improve quality of life during the pandemia (1 video about social support and one video about sleep hygiene). After 1 week, the therapist will send to the patient another 2 videos with strategies do improve quality of life (dietary guidance and guidance on physical activity)

Other: Quality of life promotion

Interventions

Internet-based Cognitive Behavioral Therapy BEHAVIORAL

2 booster sessions of cognitive behavioral therapy (CBT) delivered thru internet to patients previously treated with CBT. First session focus on understanding the symptoms of skin picking and training techniques to reverse the habit. Second session focus on comorbid symptoms of anxiety and depression, training strategies to improve it.

internet CBT

Quality of life promotion OTHER

2 videos about quality of life promotion will be send to patients in the active control arm. In the first week, the videos will consist in: social support techniques and sleep hygiene. After one week, 2 another videos will be send, consisting in: guide about healthy diet and about physical exercise.

Quality of life promotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Skin picking as a primary diagnosis
• Treatment with cognitive behavioral therapy in the past, received in previous clinical randomized trial conducted by our research group between 2014 and 2018

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (5)

• Tucker BT, Woods DW, Flessner CA, Franklin SA, Franklin ME. The Skin Picking Impact Project: phenomenology, interference, and treatment utilization of pathological skin picking in a population-based sample. J Anxiety Disord. 2011 Jan;25(1):88-95. doi: 10.1016/j.janxdis.2010.08.007. Epub 2010 Aug 13.

  PMID: 20810239 BACKGROUND

• Alexander JR, Houghton DC, Bauer CC, Lench HC, Woods DW. Emotion regulation deficits in persons with body-focused repetitive behavior disorders. J Affect Disord. 2018 Feb;227:463-470. doi: 10.1016/j.jad.2017.11.035. Epub 2017 Nov 10.

  PMID: 29156359 BACKGROUND

• Torales J, O'Higgins M, Castaldelli-Maia JM, Ventriglio A. The outbreak of COVID-19 coronavirus and its impact on global mental health. Int J Soc Psychiatry. 2020 Jun;66(4):317-320. doi: 10.1177/0020764020915212. Epub 2020 Mar 31.

  PMID: 32233719 BACKGROUND

• Xavier ACM, Souza CMB, Flores LHF, Prati C, Cassal C, Dreher CB. Improving skin picking diagnosis among Brazilians: validation of the Skin Picking Impact Scale and development of a photographic instrument. An Bras Dermatol. 2019 Sep-Oct;94(5):553-560. doi: 10.1016/j.abd.2018.10.001. Epub 2019 Sep 30.

  PMID: 31777356 RESULT

• Xavier ACM, de Souza CMB, Flores LHF, Bermudez MB, Silva RMF, de Oliveira AC, Dreher CB. Skin picking treatment with the Rothbaum cognitive behavioral therapy protocol: a randomized clinical trial. Braz J Psychiatry. 2020 Sep-Oct;42(5):510-518. doi: 10.1590/1516-4446-2019-0636.

  PMID: 32401873 RESULT

MeSH Terms

Conditions

Excoriation Disorder

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Study Officials

• Carolina Blaya Dreher, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two assessors will evaluate patients before and after the intervention, thru an online consultation and application of instruments to assess symptoms. The assessors will be blinded about the intervention received by the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized clinical trial with the intervention consisting of cognitive behavioral therapy in an online setting, and the control consisting of an active control group (guidelines about strategies to improve quality of life).

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 21, 2020
• Study Start: August 11, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 17, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)