Group Psychodrama for Skin Picking

Excoriation of Skin Clinical Trial

Official title:

Randomized Controlled Trial of Group Psychodrama for Skin Picking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073135
• Other study ID #: #14760
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: December 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2018
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Skin Picking diagnosis

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

Related Conditions & MeSH terms

• Excoriation of Skin

Intervention

Behavioral:
• Psychodrama Group Therapy (PGT)
The psychotherapeutic focus is on the "here and now" aspect of the patient's relationships. Conflicts are acted out during the sessions, yielding intense emotional re-experience in a safe environment, which will bring further cognitive understanding of past distressful life experiences and hopefully new adaptive ways of expressing and dealing with the problem.
• Supportive Group Therapy (SGT)
SGT is a form of treatment in which the therapist maintains a therapeutic relationship and a working alliance based on reality, support, clarification, assistance in troubleshooting, strong leadership, partial gratification of dependency needs, legitimating independence, development of pleasurable activities and adequate rest, guidance and advice to deal with current problems. This approach uses techniques to help patients feel safe, accepted, protected, encouraged and not anxious.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da faculdade de medicina da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Clinical Global Impression Scale Change	semi structured interview with psychiatrist	Baseline, week 15 (end of treatment.).
Other	Beck Depression Scale Change	Self-report questionnaire	Baseline, week 15 (end of treatment.).
Other	Beck Anxiety Scale Change	Self-report questionnaire	Baseline, week 15 (end of treatment.).
Other	Social Adjustment Scale Change	Self-report questionnaire	Baseline, week 15 (end of treatment.).
Primary	Skin Picking Scale Change	Self-report questionnaire	Baseline, week 5, week 10, week 15
Secondary	Difficulties in Emotion Regulation Scale Change	Self-report questionnaire	Baseline, week 5, week 10, week 15.