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Completed

NCT Number: NCT04522492

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

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

About this study

This study is a randomized clinical trial, in which patients diagnosed with skin picking disorder (SPD) will be evaluated and, if symptomatic for the disease, will be randomized to one of the arms: intervention arm with 2 booster sessions of cognitive behavioral therapy in online format; active control arm, in which individuals will watch videos with quality of life orientation. Patients included in this study are coming from a brazilian clinical trial conducted between the years of 2014 and 2018, in wich patients with SPD were treated with a cognitive behavioral treatment protocol in individual or group formats, resulting in improvement of SPD symptoms and comorbid anxiety and depression. Before the intervention, individuals will be evaluated by a psychiatrist, to assess SPD and comorbid symptoms severity, thru the application of some instruments to assess SPD, anxiety, depression and emotional regulation. Also, the CRISIS questionnaire, about the impact of COVID-19 in mental health, will be applied. After the interventions, the instruments will be applied again, by the same evaluator, wich is blinded to the type of intervention that the patient received.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Global Clinical Impression Scale

    Time frame: 2 weeks

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

Secondary outcomes

  1. Change in Beck Anxiety Inventory

    Time frame: 2 weeks

    Anxiety severity improvement after the intervention, assessed thru the Beck Anxiety Inventory

  2. Change in Beck Depression Inventory

    Time frame: 2 weeks

    Depression severity improvement after the intervention, assessed thru the Beck Depression Inventory

  3. Change of Skin Picking Impact Scale

    Time frame: 2 weeks

    Impact of Skin Picking in the life of the patient, assessed thru the Skin Picking Impact Scale

  4. Change of emotional regulation

    Time frame: 2 weeks

    Assess the correlation of emotional regulation, thru the DERS-36 (difficulties in emotional regulation scale), with the different skin picking subtypes (focused or automatic), thru the Milwaukee scale of dermatillomania subtypes.

  5. Change in Hamilton Anxiety Scale

    Time frame: 2 weeks

    Evaluate change in anxiety symptoms thru the Hamilton anxiety scale applied by blinded evaluators

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Federal University of Rio Grande do Sul

Registry information

Official study title

Impact of COVID-19 Pandemia on the Mental Health of Patients With Skin Picking Disorder and Their Treatment With Remote Cognitive Behavioral Therapy: Controlled Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 21, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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