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临床试验/NCT03182478
NCT03182478已完成不适用

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 Alegre2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
2
主要终点
Remission of symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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)

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Skin Picking diagnosis according to DSM 5 criteria

排除标准

  • Current psychotic disorder
  • Current suicide risk
  • Intellectual disability

结局指标

主要结局

Remission of symptoms

时间窗: baseline, 8 weeks, 6 months

Remission of Skin Picking symptoms, evaluated by the Clinical Global Impression Scale, with a score under or equal 2 considered remission.

次要结局

  • Improvement in Skin Picking lesions(baseline, 8 weeks, 6 months)
  • Improvement in depressive symptoms(baseline, 8 weeks, 6 months)
  • Improvement in Skin Picking life impact(baseline, 8 weeks, 6 months)
  • Improvement in anxious symptoms(baseline, 8 weeks, 6 months)

研究者

发起方
Federal University of Health Science of Porto Alegre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolina Blaya Dreher

Carolina Blaya Dreher

Federal University of Health Science of Porto Alegre

研究点 (2)

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