Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2017-05-01
2018-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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)
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Hermano Tavares
Associate Professor
Locations
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Hospital das Clínicas da faculdade de medicina da Universidade de São Paulo
São Paulo, , Brazil
Countries
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Other Identifiers
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#14760
Identifier Type: -
Identifier Source: org_study_id