Treating Skin Picking With Cognitive-Behavioral Protocol in Individual and Group Format.

NCT03182478 | Completed DMC

• 1 other identifier: U1111-1185-5527
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Skin Picking Disorder (SPD) affects 1.4-5.4% of the general population. It has a high association with anxiety and depressive symptoms. Only behavioral treatments demonstrated significant benefits compared with inactive control conditions, but with poor accessibility of this treatment to patients. Besides this, behavioral treatment does not address the associated anxious and depressive symptoms. Trichotillomania and SPD have co-occurrence rate greater than expected, indicating that can be part of the same disease spectrum. The Rothbaum Cognitive Behavioral Therapy(CBT) protocol is effective in treating trichotillomania. Based on the similarity of these diseases, this study uses the Rothbaum Protocol to treat SPD in individual and group format. We hypothesize that this protocol will be effective in treating SPD, anxiety and depression symptoms associated and also facilitate therapist training. Methods: A community sample of 40 participants with SPD will be randomly allocated to receive treatment with the Rothbaum Protocol individually or in group format. Patients with current psychotic disorder, suicide risk or mental disability will be excluded. Instruments measuring anxiety, depression and SPD severity will be applied in the baseline, after the intervention and after a 6 months follow-up. Motivation of patients to therapy will be evaluated at the baseline. The primary outcome will be the remission of symptoms evaluated by the overall clinical impression. The secondary outcomes will be the degree of improvement in anxiety, depression and SPD severity.

Conditions

Skin-Picking

Keywords

skin picking; SPD; Cognitive-Behavioral Therapy; CBT; Group treatment; Rothbaum protocol

Outcome Measures

Primary Outcomes (1)

• Remission of symptoms

  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

Secondary Outcomes (4)

• Improvement in anxious symptoms

  baseline, 8 weeks, 6 months

• Improvement in depressive symptoms

  baseline, 8 weeks, 6 months

• Improvement in Skin Picking lesions

  baseline, 8 weeks, 6 months

• Improvement in Skin Picking life impact

  baseline, 8 weeks, 6 months

Study Arms (2)

Individual Treatment

ACTIVE COMPARATOR

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

Behavioral: Rothbaum protocol in individual format

Group Treatment

ACTIVE COMPARATOR

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

Behavioral: Rothbaum protocol in group format

Interventions

Rothbaum protocol in individual format BEHAVIORAL

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.

Also known as: Cognitive-Behavioral Protocol

Individual Treatment

Rothbaum protocol in group format BEHAVIORAL

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.

Also known as: Cognitive-behavioral protocol

Group Treatment

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Skin Picking diagnosis according to DSM 5 criteria

You may not qualify if:

• Current psychotic disorder
• Current suicide risk
• Intellectual disability

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre

Pôrto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Related Publications (9)

• 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.

  PMID: 23128921 BACKGROUND

• 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.

  PMID: 22917741 BACKGROUND

• 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.

  PMID: 19223150 BACKGROUND

• Gupta MA, Gupta AK. Current concepts in psychodermatology. Curr Psychiatry Rep. 2014 Jun;16(6):449. doi: 10.1007/s11920-014-0449-9.

  PMID: 24740235 BACKGROUND

• 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: 20810239 BACKGROUND

• 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.

  PMID: 25696776 BACKGROUND

• 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.

  PMID: 20934685 BACKGROUND

• 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.

  PMID: 27143352 BACKGROUND

• 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.

  PMID: 32401873 DERIVED

MeSH Terms

Conditions

Excoriation Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

• Carolina Blaya Dreher, PhD

  Federal University of Health Science of Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients will be evaluated through scales applied before and after intervention by investigators that will be blinded about the intervention arm of the patient (individual or group format)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Carolina Blaya Dreher

Model Details: Intervention with Rothbaum protocol adapted to skin picking disorder, in individual or group format, consisting of eight weekly sessions, each session during 45 minutes in individual format and 90 minutes in group format

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 9, 2017
• Study Start: July 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2019
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)