Excoriation of SkinNCT03073135
Group Psychodrama for Skin Picking
A study testing Psychodrama Group Therapy (PGT) and Supportive Group Therapy (SGT) in people with Excoriation of Skin, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Excoriation of Skin
- What is being tested?
- Psychodrama Group Therapy (PGT) and Supportive Group Therapy (SGT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2017to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skin Picking diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da faculdade de medicina da Universidade de São Paulo
São Paulo, 05403-000
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Excoriation of Skin
- Being tested
- Psychodrama Group Therapy (PGT), Supportive Group Therapy (SGT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychodrama Group Therapy (PGT)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychodrama Group Therapy (PGT) | Experimental | 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. Receives: Behavioral: Psychodrama Group Therapy (PGT) |
| Supportive Group Therapy (SGT) | Active comparator | 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. Receives: Behavioral: Supportive Group Therapy (SGT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Picking Scale Change
Self-report questionnaire
Measured: Baseline, week 5, week 10, week 15
Secondary outcomes (1)
Difficulties in Emotion Regulation Scale Change
Self-report questionnaire
Measured: Baseline, week 5, week 10, week 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 May 2017
- Primary completion1 Oct 2017
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Excoriation of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hermano Tavares, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073135
- Sponsor's protocol ID
- #14760
- Status last verified
- Dec 2018
- First submitted
- 29 Apr 2016
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gulassa DCR, Amaral RS, Lopes Angelo D, Oliveira EC, de Abreu CN, Tavares H. Psychodrama Group Therapy for Excoriation Disorder: A Randomized Controlled Trial with a Bayesian Analysis. Int J Group Psychother. 2026 Apr;76(2):279-310. doi: 10.1080/00207284.2025.2551504. Epub 2025 Sep 30.
PubMed 41026622
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Group Psychodrama for Skin Picking
- ClinicalTrials.gov ID
- NCT03073135
- Acronym / sponsor ID
- #14760
- Conditions
- Excoriation of Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychodrama Group Therapy (PGT) | Experimental | Behavioral: 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. |
| Supportive Group Therapy (SGT) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Skin Picking diagnosis
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Psychodrama Group Therapy (PGT) |
| 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. | Behavioural | Supportive Group Therapy (SGT) |
Primary outcome
Skin Picking Scale Change
Time frame: Baseline, week 5, week 10, week 15
Self-report questionnaire
1 secondary outcome
Difficulties in Emotion Regulation Scale Change
Time frame: Baseline, week 5, week 10, week 15.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Derived from this study: PubMed 41026622Gulassa DCR, Amaral RS, Lopes Angelo D, Oliveira EC, de Abreu CN, Tavares H. Psychodrama Group Therapy for Excoriation Disorder: A Randomized Controlled Trial with a Bayesian Analysis. Int J Group Psychother. 2026 Apr;76(2):279-310. doi: 10.1080/00207284.2025.2551504. Epub 2025 Sep 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychodrama Group Therapy (PGT) and Supportive Group Therapy (SGT) in people with Excoriation of Skin, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Picking Scale Change (time frame: Baseline, week 5, week 10, week 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03073135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.