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Completed

NCT Number: NCT03073135

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.

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Key information

Conditions

Excoriation of Skin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas da faculdade de medicina da Universidade de São Paulo

São Paulo, 05403-000, Brazil

About this study

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:

  • The PGT is more effective than SGT for the ED patient regarding the reduction of skin excoriation behavior.
  • PGT is more effective than SGT for the ED patient regarding the improvement of the symptoms of anxiety, depression and trichotillomania (when present).
  • The therapeutic effects of PGT is intermediated by emotional regulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychodrama Group Therapy (PGT)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Skin Picking Scale Change

    Time frame: Baseline, week 5, week 10, week 15

    Self-report questionnaire

Secondary outcomes

  1. Difficulties in Emotion Regulation Scale Change

    Time frame: Baseline, week 5, week 10, week 15.

    Self-report questionnaire

Other outcomes

  1. The Clinical Global Impression Scale Change

    Time frame: Baseline, week 15 (end of treatment.).

    semi structured interview with psychiatrist

  2. Beck Depression Scale Change

    Time frame: Baseline, week 15 (end of treatment.).

    Self-report questionnaire

  3. Beck Anxiety Scale Change

    Time frame: Baseline, week 15 (end of treatment.).

    Self-report questionnaire

  4. Social Adjustment Scale Change

    Time frame: Baseline, week 15 (end of treatment.).

    Self-report questionnaire

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Randomized Controlled Trial of Group Psychodrama for Skin Picking

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 8, 2017
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.