Group Psychodrama for Skin Picking

Not Applicable

Completed

• Conditions: Excoriation of Skin
• Interventions: Behavioral: Psychodrama Group Therapy (PGT); Behavioral: Supportive Group Therapy (SGT)

• Registration Number: NCT03073135
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

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:

1. The PGT is more effective than SGT for the ED patient regarding the reduction of skin excoriation behavior.

2. PGT is more effective than SGT for the ED patient regarding the improvement of the symptoms of anxiety, depression and trichotillomania (when present).

3. The therapeutic effects of PGT is intermediated by emotional regulation.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-08
• Study Start: 2017-05-01
• Primary Completion: 2017-10-01
• Study Completion: 2018-07-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Skin Picking diagnosis

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychodrama Group Therapy (PGT)	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.
Supportive Group Therapy (SGT)	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.

Primary Outcome Measures

Name	Time	Method
Skin Picking Scale Change	Baseline, week 5, week 10, week 15	Self-report questionnaire

Secondary Outcome Measures

Name	Time	Method
Difficulties in Emotion Regulation Scale Change	Baseline, week 5, week 10, week 15.	Self-report questionnaire

Trial Locations

Locations (1)

Hospital das Clínicas da faculdade de medicina da Universidade de São Paulo; 🇧🇷 São Paulo, Brazil