Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT03073135
Status:
COMPLETED
Last Update Posted:
2018-12-12
First Post:
2016-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Group Psychodrama for Skin Picking
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
Randomized Controlled Trial of Group Psychodrama for Skin Picking
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: