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

F

Federal University of Health Science of Porto Alegre

Status

Completed

Conditions

Skin-Picking

Treatments

Behavioral: Rothbaum protocol in group format
Behavioral: Rothbaum protocol in individual format

Study type

Interventional

Funder types

Other

Identifiers

NCT03182478
U1111-1185-5527

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Skin Picking diagnosis according to DSM 5 criteria

Exclusion criteria

  • Current psychotic disorder
  • Current suicide risk
  • Intellectual disability

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

55 participants in 2 patient groups

Individual Treatment
Active Comparator group
Description:
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
Treatment:
Behavioral: Rothbaum protocol in individual format
Group Treatment
Active Comparator group
Description:
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
Treatment:
Behavioral: Rothbaum protocol in group format

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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