- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03182478
Treating Skin Picking With Cognitive-Behavioral Protocol in Individual and Group Format.
Improving Skin Picking Treatment Using a Cognitive-Behavioral Protocol in Individual and Group Format: a Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Skin Picking Disorder (SPD) is a new diagnosis in the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 and affects about 1.4% to 5.4% of the general population, increasing this prevalence to 7% to 30% in psychiatric patients. Despite the importance of this pathology, less than half of the patients with SPD seek treatment, only 53% receive the correct diagnosis and more than 57% are not satisfied with the treatment received. About 85% of patients think that professionals are not trained to treat SPD. Skin Picking Disorder occurs frequently with other mental disorders, with 13-48% of patients having major depressive disorder and 5-23% having anxiety disorders. The literature suggests that neither Selective Serotonin Reuptake Inhibitors (SSRIs) nor Lamotrigine are effective when compared to placebo in treating SPD, and only treatment with behavioral techniques are effective. However, studies using behavioral techniques do not address associated symptoms, as anxiety and depression.
Some studies found that the rate of co-occurrence of dermatillomania and trichotillomania is higher than expected, so it has been hypothesized that these disorders are part of the spectrum of a single pathology. It is known that the Rothbaum Protocol, a standardized treatment for Trichotillomania, is effective in treating this disorder, addressing also the management of anxiety and depressive symptoms, besides working with relapse prevention.
Thus, our study works with the hypothesis that the Rothbaum CBT Protocol can be effective in the treatment of dermatillomania, in both individual or group format. Having the same protocol to treat SPD and Trichotillomania might facilitate the patient access to treatment and the therapist training, and also might improve the SPD treatment in a long-term, by managing the relapse prevention.
Methods: this study is a thwo armed randomized controlled and single masked clinical trial. Participants with SPD according to DSM 5 will be included and randomly allocated in individual or group format of treatment with the Rothbaum CBT Protocol. The protocol will be adapted to SPD, changing the habit of pulling the hair to the habit of picking the skin. Symptoms of anxiety, depression and the SPD severity will be evaluated by specific instruments and by a photographic measurement before the intervention, after and in a 6 moths follow-up. The motivation of patient to the CBT will be measured at the baseline. Will be excluded patients with current psychotic disorder, suicide risk or mental disability.
The CBT protocol will consist of 8 weekly sessions, during 45 minutes in individual format and 90 minutes in group format, always applied by a trained therapist. This protocol includes psychoeducation, habit reversal techniques, anxiety management, change of disfunctional cognitive schemes and relapse prevention.
The primary outcome will be the remission of symptoms of SPD, assessed by the Clinical Global Impression scale. The secondary outcomes will be the improvement of depressive symptoms, anxiety and SPD symptoms assessed by the others instruments.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Rio Grande Do Sul
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Pôrto Alegre, Rio Grande Do Sul, Brazil, 90050-170
- Universidade Federal de Ciências da Saúde de Porto Alegre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Skin Picking diagnosis according to DSM 5 criteria
Exclusion Criteria:
- Current psychotic disorder
- Current suicide risk
- Intellectual disability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Individual Treatment
Intervention with the Rothbaum Protocol in individual format, with eight weekly sessions each one of 45 minutes, applied by a trained investigator.
Session 1: Psychoeducation and self-monitoring.
Session 2: habit reversal techniques.
Session 3: muscle relaxation and diaphragmatic breathing.
Session 4: stop the thought.
Session 5: oriented internal dialogue.
Session 6: cognitive techniques.
Session 7: role-play.
Session 8: relapse prevention
|
8-week 45 minute session Rothbaum CBT protocol adapted to Skin Picking, changing the focus on pulling hair to picking skin.
Session 1: psychoeducation of the skin picking habit and how CBT works, patients initiate the self-monitoring of the habit.
Session 2: techniques of habit reverse, adapted by having the skin as a target instead of the hair.
The session 3: anxiety management using diaphragmatic breathing and muscle relaxation.
Sessions 4 to 6: management of dysfunctional thoughts, using cognitive tools as the evidence analysis, reattribution of roles and gravity scale.
Session 7: change of roles and role-playing, with patient playing the role of therapist, applying the Rothbaum Protocol to treat Skin Picking, so reviewing all the protocol techniques.
Session 8: relapse prevention.
Other Names:
|
Active Comparator: Group Treatment
Intervention with the Rothbaum Protocol in group format up to 10 patients, with eight weekly sessions each one of 90 minutes, applied by a trained investigator.
Session 1: Psychoeducation and self-monitoring.
Session 2: habit reversal techniques.
Session 3: muscle relaxation and diaphragmatic breathing.
Session 4: stop the thought.
Session 5: oriented internal dialogue.
Session 6: cognitive techniques.
Session 7: role-play.
Session 8: relapse prevention
|
8-week 90 minute session of Rothbaum CBT protocol adapted to Skin Picking, changing the focus on pulling hair to picking skin.
Session 1: psychoeducation of the skin picking habit and how CBT works, patients initiate the self-monitoring of the habit.
Session 2: techniques of habit reverse, adapted by having the skin as a target instead of the hair.
The session 3: anxiety management using diaphragmatic breathing and muscle relaxation.
Sessions 4 to 6: management of dysfunctional thoughts, using cognitive tools as the evidence analysis, reattribution of roles and gravity scale.
Session 7: change of roles and role-playing, with patient playing the role of therapist, applying the Rothbaum Protocol to treat Skin Picking, so reviewing all the protocol techniques.
Session 8: relapse prevention.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remission of symptoms
Time Frame: baseline, 8 weeks, 6 months
|
Remission of Skin Picking symptoms, evaluated by the Clinical Global Impression Scale, with a score under or equal 2 considered remission.
|
baseline, 8 weeks, 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in anxious symptoms
Time Frame: baseline, 8 weeks, 6 months
|
Mean Change From BaselineI in anxious symptoms assessed by the Hamilton Anxiety Scale
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baseline, 8 weeks, 6 months
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Improvement in depressive symptoms
Time Frame: baseline, 8 weeks, 6 months
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Mean Change From Baseline, assessed by the Beck Depression Inventory
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baseline, 8 weeks, 6 months
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Improvement in Skin Picking lesions
Time Frame: baseline, 8 weeks, 6 months
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Mean Change From Baseline, assessed by the photographic measurement
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baseline, 8 weeks, 6 months
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Improvement in Skin Picking life impact
Time Frame: baseline, 8 weeks, 6 months
|
Mean Change From Baseline, assessed by the Skin Picking Impact Scale.
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baseline, 8 weeks, 6 months
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Collaborators and Investigators
Investigators
- Study Director: Carolina Blaya Dreher, PhD, Federal University of Health Science of Porto Alegre
Publications and helpful links
General Publications
- Grant JE, Odlaug BL, Chamberlain SR, Keuthen NJ, Lochner C, Stein DJ. Skin picking disorder. Am J Psychiatry. 2012 Nov;169(11):1143-9. doi: 10.1176/appi.ajp.2012.12040508.
- Snorrason I, Belleau EL, Woods DW. How related are hair pulling disorder (trichotillomania) and skin picking disorder? A review of evidence for comorbidity, similarities and shared etiology. Clin Psychol Rev. 2012 Nov;32(7):618-29. doi: 10.1016/j.cpr.2012.05.008. Epub 2012 Jul 20.
- Hayes SL, Storch EA, Berlanga L. Skin picking behaviors: An examination of the prevalence and severity in a community sample. J Anxiety Disord. 2009 Apr;23(3):314-9. doi: 10.1016/j.janxdis.2009.01.008. Epub 2009 Jan 23.
- Gupta MA, Gupta AK. Current concepts in psychodermatology. Curr Psychiatry Rep. 2014 Jun;16(6):449. doi: 10.1007/s11920-014-0449-9.
- 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.
- Keuthen NJ, Tung ES, Reese HE, Raikes J, Lee L, Mansueto CS. Getting the word out: cognitive-behavioral therapy for trichotillomania (hair-pulling disorder) and excoriation (skin-picking) disorder. Ann Clin Psychiatry. 2015 Feb;27(1):10-5.
- Schuck K, Keijsers GP, Rinck M. The effects of brief cognitive-behaviour therapy for pathological skin picking: A randomized comparison to wait-list control. Behav Res Ther. 2011 Jan;49(1):11-7. doi: 10.1016/j.brat.2010.09.005. Epub 2010 Sep 22.
- Selles RR, McGuire JF, Small BJ, Storch EA. A systematic review and meta-analysis of psychiatric treatments for excoriation (skin-picking) disorder. Gen Hosp Psychiatry. 2016 Jul-Aug;41:29-37. doi: 10.1016/j.genhosppsych.2016.04.001. Epub 2016 Apr 13.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- U1111-1185-5527
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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