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

Study Overview
=================
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.

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

Conditions
-----------------
Skin-Picking

Intervention / Treatment
-----------------
* Behavioral: Rothbaum protocol in individual format
* Behavioral: Rothbaum protocol in group format


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Skin Picking diagnosis according to DSM 5 criteria Exclusion Criteria: Current psychotic disorder Current suicide risk Intellectual disability

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Individual Treatment<br>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<br>* 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.<br>* Other names: Cognitive-Behavioral Protocol;|
| Active Comparator: Group Treatment<br>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<br>* 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.<br>* Other names: Cognitive-behavioral protocol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in anxious symptoms | Mean Change From BaselineI in anxious symptoms assessed by the Hamilton Anxiety Scale | baseline, 8 weeks, 6 months | 
| Improvement in depressive symptoms | Mean Change From Baseline, assessed by the Beck Depression Inventory | baseline, 8 weeks, 6 months | 
| Improvement in Skin Picking lesions | Mean Change From Baseline, assessed by the photographic measurement | baseline, 8 weeks, 6 months | 
| Improvement in Skin Picking life impact | Mean Change From Baseline, assessed by the Skin Picking Impact Scale. | baseline, 8 weeks, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin picking, SPD, Cognitive-Behavioral Therapy, CBT, Group treatment, Rothbaum protocol