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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03182478
Enrollment
55
Registered
2017-06-09
Start date
2016-07-31
Completion date
2019-06-30
Last updated
2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin-Picking

Keywords

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

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.

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.

Interventions

BEHAVIORALRothbaum protocol in individual format

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.

BEHAVIORALRothbaum protocol in group format

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.

Sponsors

Federal University of Health Science of Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Skin Picking diagnosis according to DSM 5 criteria

Exclusion criteria

* Current psychotic disorder * Current suicide risk * Intellectual disability

Design outcomes

Primary

MeasureTime frameDescription
Remission of symptomsbaseline, 8 weeks, 6 monthsRemission of Skin Picking symptoms, evaluated by the Clinical Global Impression Scale, with a score under or equal 2 considered remission.

Secondary

MeasureTime frameDescription
Improvement in anxious symptomsbaseline, 8 weeks, 6 monthsMean Change From BaselineI in anxious symptoms assessed by the Hamilton Anxiety Scale
Improvement in depressive symptomsbaseline, 8 weeks, 6 monthsMean Change From Baseline, assessed by the Beck Depression Inventory
Improvement in Skin Picking lesionsbaseline, 8 weeks, 6 monthsMean Change From Baseline, assessed by the photographic measurement
Improvement in Skin Picking life impactbaseline, 8 weeks, 6 monthsMean Change From Baseline, assessed by the Skin Picking Impact Scale.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026