CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Rothbaum protocol in individual format +1 morebehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03182478
NCT03182478N/ACompleted

Improving Skin Picking Treatment Using a Cognitive-Behavioral Protocol in Individual and Group Format: a Randomized Clinical Trial

Federal University of Health Science of Porto Alegre·interventional·Posted Jun 9, 2017·Updated Apr 29, 2020

In Brief

A clinical study evaluating Rothbaum protocol in individual format and Rothbaum protocol in group format for Skin-Picking. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin-Picking
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 9, 2017
Enrollment StartJul 1, 2016
Primary CompletionApr 1, 2018
Study CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.1 years ago

Interventions

Rothbaum protocol in individual formatbehavioral

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.

Rothbaum protocol in group formatbehavioral

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.