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

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ClinicalTrials.gov Identifier: NCT04522492
Recruitment Status : Active, not recruiting
First Posted : August 21, 2020
Last Update Posted : August 25, 2021
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Skin Picking Behavioral: Internet-based Cognitive Behavioral Therapy Other: Quality of life promotion Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 11, 2020
Actual Primary Completion Date : March 1, 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: internet CBT
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
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.

Active Comparator: Quality of life promotion
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
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522492


Locations
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Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Investigators
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Principal Investigator: Carolina Blaya Dreher, PhD Federal University of Rio Grande do Sul
Publications of Results:
Other Publications:
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT04522492    
Other Study ID Numbers: 31520820.1.0000.5327
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No