Randomized Controlled Trial of Group Psychodrama for Skin Picking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Skin Picking Scale Change
研究概览
简要总结
This study aims to evaluate the effectiveness of psychodrama group therapy (PGT) compared with supportive group therapy (SGT) for excoriation disorder (ED). Patients will be randomly allocated for either PGT or SGT. The Skin Picking Scale Revised (SPS-R) will be the primary outcome and emotional regulation measured by the Difficulties in Emotion Regulation Scale (DERS) will be evaluated as a potential intermediator. The Clinical Global Impression Scale (CGI); Beck Depression Scale (BDI); Beck Anxiety Scale (BAI), and the Social Adjustment Scale (EAS) will assess secondary outcomes.
详细描述
Excoriation disorder (ED) is a diagnostic characterized by recurrent picking at one´s own skin, resulting in skin lesions, despite repeated attempts to stop the behavior that causes clinically significant distress or impairment in important areas of functioning. The skin picking behavior is better accounted by physiological effects of a substance or better explained by symptoms of another mental disorder.
Objective: This study aims to evaluate the effectiveness of psychodrama group therapy (PGT) compared with supportive group therapy (SGT).
Justification: The scientific studies on treatment for ED are scarce and all associated with behavioral therapy methods, which do not adequately consider underlying factors of ED, such as emotional dysregulation. There are also not reports of group treatment for ED.
Method: patients who meet criteria for ED according to DSM-5 will be selected . Patients in need of treatment for psychiatric comorbidities (such as anxiety and depression) will wait at least 4 weeks until pharmacological prescription is stable. The subjects will be randomly allocated to either PGT or SGT. The Skin Picking Scale Revised (SPS-R) will be the primary outcome and emotional regulation measured by the Difficulties in Emotion Regulation Scale (DERS) will be evaluated as a potential intermediator. The Clinical Global Impression Scale (CGI); Beck Depression Scale (BDI); Beck Anxiety Scale (BAI), and the Social Adjustment Scale (EAS) will assess secondary outcomes.
Hypotheses:
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skin Picking diagnosis
排除标准
- •Illiteracy
- •Other acute psychiatric diagnosis in need of inpatient treatment
- •Mental retardation
- •Prader-Willi syndrome or other medical condition causing recurrent excoriation behavior or intense itching
研究组 & 干预措施
Psychodrama Group Therapy (PGT)
The PGT is a 15-session weekly program. Sessions last one and a half hours, conducted by two psychologists with more than ten years of experience. The process will be divided into three stages: the first (5 sessions) will be focused on the management of the individual's relationship challenges. The second stage (5 sessions) will focus on the association between the subject's management of their relationships and the excoriation disorder (ED) symptoms. The third (5 sessions) will focus on the development of new skills for the management of ED. Psychodramatic methods will be used throughout the process.
干预措施: Psychodrama Group Therapy (PGT) (Behavioral)
Supportive Group Therapy (SGT)
The SGT is a 15-session weekly program. Sessions last one and a half hours, conducted by two psychologists with more than ten years of experience.
干预措施: Supportive Group Therapy (SGT) (Behavioral)
结局指标
主要结局
Skin Picking Scale Change
时间窗: Baseline, week 5, week 10, week 15
Self-report questionnaire
次要结局
- Difficulties in Emotion Regulation Scale Change(Baseline, week 5, week 10, week 15.)
研究者
Hermano Tavares
Associate Professor
University of Sao Paulo