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
|Condition or disease||Intervention/treatment||Phase|
|Skin Picking||Behavioral: Internet-based Cognitive Behavioral Therapy Other: Quality of life promotion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|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.|
|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|
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.
- 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.
- Change in Beck Anxiety Inventory [ Time Frame: 2 weeks ]Anxiety severity improvement after the intervention, assessed thru the Beck Anxiety Inventory
- Change in Beck Depression Inventory [ Time Frame: 2 weeks ]Depression severity improvement after the intervention, assessed thru the Beck Depression Inventory
- 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
- 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.
- Change in Hamilton Anxiety Scale [ Time Frame: 2 weeks ]Evaluate change in anxiety symptoms thru the Hamilton anxiety scale applied by blinded evaluators
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
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|
|Principal Investigator:||Carolina Blaya Dreher, PhD||Federal University of Rio Grande do Sul|