Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-01 @ 6:22 PM
Study NCT ID:
NCT04522492
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2020-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of COVID-19 on Mental Health of Patients With Skin Picking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096705', 'term': 'Excoriation Disorder'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007174', 'term': 'Disruptive, Impulse Control, and Conduct Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Global Clinical Impression Scale', 'timeFrame': '2 weeks', 'description': 'The skin picking improvement after intervention will be assessed by the change in the Global Clinical Impression Scale, applied by blinded evaluators.'}], 'secondaryOutcomes': [{'measure': 'Change in Beck Anxiety Inventory', 'timeFrame': '2 weeks', 'description': 'Anxiety severity improvement after the intervention, assessed thru the Beck Anxiety Inventory'}, {'measure': 'Change in Beck Depression Inventory', 'timeFrame': '2 weeks', 'description': 'Depression severity improvement after the intervention, assessed thru the Beck Depression Inventory'}, {'measure': 'Change of Skin Picking Impact Scale', 'timeFrame': '2 weeks', 'description': 'Impact of Skin Picking in the life of the patient, assessed thru the Skin Picking Impact Scale'}, {'measure': 'Change of emotional regulation', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Change in Hamilton Anxiety Scale', 'timeFrame': '2 weeks', 'description': 'Evaluate change in anxiety symptoms thru the Hamilton anxiety scale applied by blinded evaluators'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Picking']}, 'referencesModule': {'references': [{'pmid': '20810239', 'type': 'BACKGROUND', 'citation': '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': '29156359', 'type': 'BACKGROUND', 'citation': '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': '32233719', 'type': 'BACKGROUND', 'citation': "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': '31777356', 'type': 'RESULT', 'citation': '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': '32401873', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Skin picking as a primary diagnosis\n* Treatment with cognitive behavioral therapy in the past, received in previous clinical randomized trial conducted by our research group between 2014 and 2018\n\nExclusion Criteria:\n\n* Acute psychotic disorder, bipolar affective disorder in an acute episode, substance use disorder (except tobacco), severe depressive episode or suicidal ideation, dementia'}, 'identificationModule': {'nctId': 'NCT04522492', 'briefTitle': 'Impact of COVID-19 on Mental Health of Patients With Skin Picking', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '31520820.1.0000.5327'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'internet CBT', 'description': '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).', 'interventionNames': ['Behavioral: Internet-based Cognitive Behavioral Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Quality of life promotion', 'description': '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)', 'interventionNames': ['Other: Quality of life promotion']}], 'interventions': [{'name': 'Internet-based Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['internet CBT']}, {'name': 'Quality of life promotion', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Quality of life promotion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Carolina Blaya Dreher, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Rio Grande do Sul'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal University of Rio Grande do Sul', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}