Clinical trial NCT03073135: Group Psychodrama for Skin Picking
Official title: Randomized Controlled Trial of Group Psychodrama for Skin Picking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excoriation of Skin
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Skin Picking Scale Change
timeFrame: Baseline, week 5, week 10, week 15
Secondary outcomes:
measure: Difficulties in Emotion Regulation Scale Change
timeFrame: Baseline, week 5, week 10, week 15.
Other outcomes:
measure: The Clinical Global Impression Scale Change
timeFrame: Baseline, week 15 (end of treatment.).
measure: Beck Depression Scale Change
timeFrame: Baseline, week 15 (end of treatment.).
measure: Beck Anxiety Scale Change
timeFrame: Baseline, week 15 (end of treatment.).
measure: Social Adjustment Scale Change
timeFrame: Baseline, week 15 (end of treatment.).
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da faculdade de medicina da Universidade de São Paulo
Study officials:
References: