Group Psychodrama for Skin Picking

Randomized Controlled Trial of Group Psychodrama for Skin Picking

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.

Study Overview

• Status: Completed
• Conditions: Excoriation of Skin
• Intervention / Treatment: Behavioral: Psychodrama Group Therapy (PGT); Behavioral: Supportive Group Therapy (SGT)

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-000
    • Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Picking Scale Change	Self-report questionnaire	Baseline, week 5, week 10, week 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulties in Emotion Regulation Scale Change	Self-report questionnaire	Baseline, week 5, week 10, week 15.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Clinical Global Impression Scale Change	semi structured interview with psychiatrist	Baseline, week 15 (end of treatment.).
Beck Depression Scale Change	Self-report questionnaire	Baseline, week 15 (end of treatment.).
Beck Anxiety Scale Change	Self-report questionnaire	Baseline, week 15 (end of treatment.).
Social Adjustment Scale Change	Self-report questionnaire	Baseline, week 15 (end of treatment.).

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: #14760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No