xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05991596</url>
    </required_header>
    <id_info>
      <org_study_id>A800</org_study_id>
      <nct_id>NCT05991596</nct_id>
    </id_info>
    <brief_title>Vitiligo and Psychodrama Therapy</brief_title>
    <official_title>Vitiligo and Psychological Distress: Pilot Study for the Experimentation of a Psychodramatic Psychotherapy Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Università degli Studi di Brescia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Scuola Psicoterapia Psicodrammatica Brescia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Università degli Studi di Trento</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this pilot clinical trial is to assess the effectiveness of psychodramatic&#xD;
        psychotherapy in reducing the psychological distress and/or the skin condition in patients&#xD;
        with vitiligo.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          1. Is there any improvement in terms of psychological distress in patients with vitiligo&#xD;
             participating in a psychodramatic psychotherapy, compared to a control group?&#xD;
  &#xD;
          2. Is there any improvement in terms of skin condition in patients with vitiligo&#xD;
             participating in a psychodramatic psychotherapy, compared to a control group?&#xD;
             Participants in the experimental group will receive the dermatological drug treatment&#xD;
             usually recommended for vitiligo, and in addition they will participate in a 6 months&#xD;
             psychodramatic psychotherapy.&#xD;
  &#xD;
        Researchers will compare the results of the experimental group with the results of a control&#xD;
        group including vitiligo patients who will receive the dermatological pharmacological&#xD;
        treatment usually recommended for vitiligo and participate in a 6 months program of self-help&#xD;
        activities.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary aim of this pilot study is to assess any possible improvement in terms of&#xD;
        psychological distress in patients with vitiligo participating in a psychodramatic&#xD;
        psychotherapy (PSD), in addition to the usual pharmacological treatment with hydrocortisone&#xD;
        and heliotherapy.&#xD;
  &#xD;
        The secondary aim is to assess any improvement in terms of vitiligo skin condition and/or&#xD;
        other systemic autoimmune diseases symptoms.&#xD;
  &#xD;
        The study will involve 24 patients with vitiligo aged between 18 and 55 years, attending the&#xD;
        dermatology services of the Azienda Provinciale per i Servizi Sanitari (APSS) of Trento.&#xD;
  &#xD;
        Patients will be randomly assigned to one of the two groups:&#xD;
  &#xD;
          -  12 patients will receive the dermatological pharmacological treatment usually&#xD;
             recommended for vitiligo, and in addition they will participate in a psychodramatic&#xD;
             group psychotherapy for 6 months (PSD experimental group);&#xD;
  &#xD;
          -  12 patients will receive the dermatological pharmacological treatment usually&#xD;
             recommended for vitiligo, and in addition they will receive self-help activities for 6&#xD;
             months (non-PSD control group).&#xD;
  &#xD;
        The experimental group (PSD) will attend the psychodramatic psychotherapy, which will&#xD;
        include:&#xD;
  &#xD;
          -  1 individual motivational interview;&#xD;
  &#xD;
          -  1 weekly group session lasting 2 hours for 1 month (total 4 meetings);&#xD;
  &#xD;
          -  1 group session every 15 days lasting 2 hours, for 5 months (total 10 meetings).&#xD;
  &#xD;
        The control group (non-PSD) will attend self-help activities as follows:&#xD;
  &#xD;
          -  1 individual motivational interview;&#xD;
  &#xD;
          -  1 weekly, 2 hours group meeting, for 1 month (total 4 meetings);&#xD;
  &#xD;
          -  1 group meeting lasting 2 hours every 15 days, for 5 months (total 10 meetings).&#xD;
  &#xD;
        To all patients participating in the study, the following pharmacological treatment will be&#xD;
        administered:&#xD;
  &#xD;
          -  Hydrocortisone acetate with the following dosage: 1 Finger Unit /15 cm2 per day.&#xD;
             Duration: 10 days a month for 6 months.&#xD;
  &#xD;
          -  Free exposure to the sun without photoprotection from 9.00 AM to 11.00 AM.&#xD;
  &#xD;
        A clinical evaluation will be carried out at:&#xD;
  &#xD;
        Time 0 (T0): right before the beginning of the intervention Time 1 (T1): after 6 months, at&#xD;
        the end of the intervention For both groups, a follow-up will be performed after 6 months&#xD;
        from the end of the intervention (psychodramatic psychotherapy or self-help activities).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Improvement of the levels of psychological distress of patients with vitiligo</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>The General Health Questionnaire (GHQ-12), a self-administered questionnaire covering several domains associated with a person's psychological well-being, will be administered to all patients. Scoring is along a 4-point scale (total score ranging from 0 to 36) with higher scores suggestive of more distress.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improvement of the levels of psychological distress of patients with vitiligo, in terms of psychological, functional or physical state.</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>The Short-Form Health Survey (SF-36): a health status profile originally designed to measure health status and outcomes, will be administered to all patients. This instrument addresses health concepts from the patient's perspective and its 36 questions are meant to reflect 8 domains of health, evaluating any changes in the psychological, functional or physical state of patients. SF-36 scores range from 0 (worst) to 100 (best).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improvement of the levels of psychological distress of patients with vitiligo, in terms of anxiety symptoms</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>The Beck Anxiety Inventory (B.A.I.), a self-report measure of anxiety, will be administered to all patients. The BAI items are scored on a scale between 0 and 3 and have a maximum score of 63, with higher scores suggestive of higher levels of anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improvement of the levels of psychological distress of patients with vitiligo, in terms of depressive symptoms</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>The Beck Depression Inventory (B.D.I.), a 21-question multiple-choice self-report inventory and one of the most widely used instruments for measuring the severity of depression, will be administered to all patients. A value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. Higher total scores indicate more severe depressive symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improvement of the levels of psychological distress of patients with vitiligo, in terms of spontaneity</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>The Revised Spontaneity Assessment Inventory (SAI-R) will be administered to all patients. The SAI-R is a scale for the assessment of spontaneity, evaluating feelings and thoughts that people experience in different daily situations. It includes 18 items, scored on a 5-point Likert scale. Higher total scores indicate higher levels of spontaneity (score range: 18-90)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of dermatological lesions related to vitiligo and any re-pigmentation</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>The Vitiligo Extent Score (VES) will be administered. The VES will be administered at Time 0 in order to evaluating the extent of vitiligo, and at Time 1 to evaluate any repigmentation. The VES is a template of vitiligo images that measures vitiligo at 19 different areas of the body. The physician has to score these 19 body areas separately by selecting the image that most resembles to patient's clinical in that body area, ranging from no lesion to almost 100% lesion coverage.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of personal perception of the patient</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>The Self Administered version of Vitiligo Extent score (SA-VES) will be administered. The SA-VES is a patient-reported outcome measurement instrument that is similar to the VES (it includes only 12 areas). It will be self- administered at Time 0 in order to evaluating the extent of vitiligo, and at Time 1 to evaluate any repigmentation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of quality of life associated with the skin condition</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>Skindex-29, a three-dimensional, dermatology-specific Health-related quality of life questionnaire, will be administered. Skindex-29 items are combined to form three domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, with higher scores indicating lower levels of quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Multidimensional improvement of vitiligo</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>An adaptation of the Vitiligo Questionnaire ITA 4.0 will be administered. The Vitiligo Questionnaire ITA 4.0 measures several aspects of health status in vitiligo patients. It is self-administered and features thirty questions in five sections. These cover biologic factors, symptom status, functional status, treatment outcome perception, and economic impact.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of other autoimmune diseases, in terms of levels of levels of Thyroid Stimulating Hormone</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>Blood chemistry tests will be conducted to assess levels of Thyroid Stimulating Hormone (TSH), a pituitary thyroid-stimulating hormone that regulates thyroid activity. Reference values are 0.2-4.5 mU/L. Higher values may indicate thyroid hormone deficiency, lower levels may indicate thyroid hormone excess.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of other autoimmune diseases, in terms of levels of S-Free T4-Thyroxine</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>Blood chemistry tests will be conducted to assess levels of S-Free T4-Thyroxine (FT4), a thyroid hormone that regulates the body's metabolism, secretion of which is controlled by thyroid-stimulating hormone (TSH) produced by the pituitary gland. Reference values are 12.0 - 22.0 pmol/L. Higher values may indicate hyperthyroidism, lower levels may indicate hypothyroidism.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of other autoimmune diseases, in terms of levels of Anti Thyroglobulin</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>Blood chemistry tests will be conducted to assess levels of Anti Thyroglobulin (HTG), antibodies produced against thyroglobulin, a precursor protein of thyroid hormones triiodothyronine (FT3) and free thyroxine (FT4), indicating autoimmune pathology. Threshold value is 115 IU/ml; higher values may indicate possible development of hypothyroidism.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of other autoimmune diseases, in terms of levels of Anti Thyroperoxidase</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>Blood chemistry tests will be conducted to assess levels of Anti Thyroperoxidase (TPO), an antibody which, attacking the enzyme peroxidase, identifying autoimmune thyroid disease.&#xD;
  Threshold value is 34 IU/ml; higher values may be associated with either hyperthyroidism or hypothyroidism (depending on whether it's Graves' disease or Hashimoto's thyroiditis).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of other autoimmune diseases, in terms of levels of Antinuclear Antibodies</measure>
      <time_frame>Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention</time_frame>
      <description>Blood chemistry tests will be conducted to assess levels of Antinuclear Antibodies (ANA), antibodies produced by the body's immune system, indicating the presence of autoantibodies in circulating blood.&#xD;
  Threshold value is 1:160.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Vitiligo</condition>
    <arm_group>
      <arm_group_label>Psychodramatic Psychotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This experimental arm will include 12 patients with vitiligo (randomly assigned to this arm), attending the dermatology services of APSS Trento.&#xD;
  This experimental group will receive the drug treatment usually recommended for vitiligo, in addition to 6 months of psychodramatic psychotherapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Self-help activities</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This is a control arm which will include 12 patients with vitiligo (randomly assigned to this arm), attending the dermatology services of APSS Trento. This control group will receive the drug treatment usually recommended for vitiligo, in addition to 6 months of self-help activities.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Psychodramatic psychotherapy</intervention_name>
      <description>The psychodramatic psychotherapy will include a total of 14 meetings during a 6 months period and they will be held in presence (or remotely in case of COVID-19 government restrictions) as follows:&#xD;
  1 individual motivational interview;&#xD;
  1 weekly group session lasting 2 hours for 1 month (total 4 meetings);&#xD;
  1 group session every 15 days lasting 2 hours, for 5 months (total 10 meetings).&#xD;
  Patients will also receive the pharmacological treatment usually recommended for vitiligo.</description>
      <arm_group_label>Psychodramatic Psychotherapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Self-help activities</intervention_name>
      <description>The self-help activities will include:&#xD;
  1 individual motivational interview;&#xD;
  1 weekly, 2 hours group meeting, for 1 month (total 4 meetings);&#xD;
  1 group meeting lasting 2 hours every 15 days, for 5 months (total 10 meetings).&#xD;
  Patients will also receive pharmacological treatment usually recommended for vitiligo.</description>
      <arm_group_label>Self-help activities</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Segmental vitiligo with unilateral localization.&#xD;
  &#xD;
            2. Non-segmental vitiligo (acrofacial; mucosal with more than one side affected;&#xD;
               generalized universal; mixed associated with segmental vitiligo).&#xD;
  &#xD;
            3. Vitiligo-associated autoimmune comorbidity referred to in points 1-2: Thyroiditis.&#xD;
  &#xD;
            4. Symptoms of depression and/or anxiety and/or low self-esteem associated with Vitiligo&#xD;
               mentioned in points 1-2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cognitive impairment/dementia (clinically diagnosed).&#xD;
  &#xD;
            -  Individual and/or group psychotherapy in progress.&#xD;
  &#xD;
            -  Have previously received other psychotherapy.&#xD;
  &#xD;
            -  Use of psychiatric drugs in the last 3 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gabriella Pravatà, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>APSS Trento</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gabriella Pravatà, MD</last_name>
      <phone>+393396749999</phone>
      <email>gabriella.pravata@apss.tn.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>APSS Trento</name>
        <address>
          <city>Trento</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Gabriella Pravatà, MD</last_name>
        <phone>+393396749999</phone>
        <email>gabriella.pravata@apss.tn.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
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    <reference>
      <citation>Ron Y. Psychodrama's Role in Alleviating Acute Distress: A Case Study of an Open Therapy Group in a Psychiatric Inpatient Ward. Front Psychol. 2018 Oct 30;9:2075. doi: 10.3389/fpsyg.2018.02075. eCollection 2018.</citation>
      <PMID>30425674</PMID>
    </reference>
    <reference>
      <citation>Croce EB. La realtà in gioco. Reale e realtà in psicodramma analitico. 2001; Rome, Italy: Borla.</citation>
    </reference>
    <reference>
      <citation>Kipper DA, Ritchie TD. The effectiveness of psychodramatic techniques: a meta-analysis. Group Dynamics: Theory, Research and Practice 2003; 7(1): 13-25.</citation>
    </reference>
    <reference>
      <citation>Qureshi AA, Awosika O, Baruffi F, Rengifo-Pardo M, Ehrlich A. Psychological Therapies in Management of Psoriatic Skin Disease: A Systematic Review. Am J Clin Dermatol. 2019 Oct;20(5):607-624. doi: 10.1007/s40257-019-00437-7.</citation>
      <PMID>30937679</PMID>
    </reference>
    <reference>
      <citation>Erbay LG, Reyhani I, Unal S, Ozcan C, Ozgocer T, Ucar C, Yildiz S. Does Psychodrama Affect Perceived Stress, Anxiety-Depression Scores and Saliva Cortisol in Patients with Depression? Psychiatry Investig. 2018 Oct;15(10):970-975. doi: 10.30773/pi.2018.08.11.2. Epub 2018 Oct 11.</citation>
      <PMID>30301307</PMID>
    </reference>
    <reference>
      <citation>Gulassa D, Amaral R, Oliveira E, Tavares H. Group therapy for excoriation disorder: Psychodrama versus support therapy. Ann Clin Psychiatry. 2019 May;31(2):84-94.</citation>
      <PMID>31046029</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento</investigator_affiliation>
      <investigator_full_name>Gabriella Pravata</investigator_full_name>
      <investigator_title>Medical Doctor, Dermatologist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitiligo</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05991596
  org study id: A800
  nct id: NCT05991596
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this pilot clinical trial is to assess the effectiveness of psychodramatic
        psychotherapy in reducing the psychological distress and/or the skin condition in patients
        with vitiligo.
  
        The main questions it aims to answer are:
  
          1. Is there any improvement in terms of psychological distress in patients with vitiligo
             participating in a psychodramatic psychotherapy, compared to a control group?
  
          2. Is there any improvement in terms of skin condition in patients with vitiligo
             participating in a psychodramatic psychotherapy, compared to a control group?
             Participants in the experimental group will receive the dermatological drug treatment
             usually recommended for vitiligo, and in addition they will participate in a 6 months
             psychodramatic psychotherapy.
  
        Researchers will compare the results of the experimental group with the results of a control
        group including vitiligo patients who will receive the dermatological pharmacological
        treatment usually recommended for vitiligo and participate in a 6 months program of self-help
        activities.
  The primary aim of this pilot study is to assess any possible improvement in terms of
        psychological distress in patients with vitiligo participating in a psychodramatic
        psychotherapy (PSD), in addition to the usual pharmacological treatment with hydrocortisone
        and heliotherapy.
  
        The secondary aim is to assess any improvement in terms of vitiligo skin condition and/or
        other systemic autoimmune diseases symptoms.
  
        The study will involve 24 patients with vitiligo aged between 18 and 55 years, attending the
        dermatology services of the Azienda Provinciale per i Servizi Sanitari (APSS) of Trento.
  
        Patients will be randomly assigned to one of the two groups:
  
          -  12 patients will receive the dermatological pharmacological treatment usually
             recommended for vitiligo, and in addition they will participate in a psychodramatic
             group psychotherapy for 6 months (PSD experimental group);
  
          -  12 patients will receive the dermatological pharmacological treatment usually
             recommended for vitiligo, and in addition they will receive self-help activities for 6
             months (non-PSD control group).
  
        The experimental group (PSD) will attend the psychodramatic psychotherapy, which will
        include:
  
          -  1 individual motivational interview;
  
          -  1 weekly group session lasting 2 hours for 1 month (total 4 meetings);
  
          -  1 group session every 15 days lasting 2 hours, for 5 months (total 10 meetings).
  
        The control group (non-PSD) will attend self-help activities as follows:
  
          -  1 individual motivational interview;
  
          -  1 weekly, 2 hours group meeting, for 1 month (total 4 meetings);
  
          -  1 group meeting lasting 2 hours every 15 days, for 5 months (total 10 meetings).
  
        To all patients participating in the study, the following pharmacological treatment will be
        administered:
  
          -  Hydrocortisone acetate with the following dosage: 1 Finger Unit /15 cm2 per day.
             Duration: 10 days a month for 6 months.
  
          -  Free exposure to the sun without photoprotection from 9.00 AM to 11.00 AM.
  
        A clinical evaluation will be carried out at:
  
        Time 0 (T0): right before the beginning of the intervention Time 1 (T1): after 6 months, at
        the end of the intervention For both groups, a follow-up will be performed after 6 months
        from the end of the intervention (psychodramatic psychotherapy or self-help activities).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Improvement of the levels of psychological distress of patients with vitiligo
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: The General Health Questionnaire (GHQ-12), a self-administered questionnaire covering several domains associated with a person's psychological well-being, will be administered to all patients. Scoring is along a 4-point scale (total score ranging from 0 to 36) with higher scores suggestive of more distress.
  measure: Improvement of the levels of psychological distress of patients with vitiligo, in terms of psychological, functional or physical state.
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: The Short-Form Health Survey (SF-36): a health status profile originally designed to measure health status and outcomes, will be administered to all patients. This instrument addresses health concepts from the patient's perspective and its 36 questions are meant to reflect 8 domains of health, evaluating any changes in the psychological, functional or physical state of patients. SF-36 scores range from 0 (worst) to 100 (best).
  measure: Improvement of the levels of psychological distress of patients with vitiligo, in terms of anxiety symptoms
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: The Beck Anxiety Inventory (B.A.I.), a self-report measure of anxiety, will be administered to all patients. The BAI items are scored on a scale between 0 and 3 and have a maximum score of 63, with higher scores suggestive of higher levels of anxiety.
  measure: Improvement of the levels of psychological distress of patients with vitiligo, in terms of depressive symptoms
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: The Beck Depression Inventory (B.D.I.), a 21-question multiple-choice self-report inventory and one of the most widely used instruments for measuring the severity of depression, will be administered to all patients. A value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. Higher total scores indicate more severe depressive symptoms.
  measure: Improvement of the levels of psychological distress of patients with vitiligo, in terms of spontaneity
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: The Revised Spontaneity Assessment Inventory (SAI-R) will be administered to all patients. The SAI-R is a scale for the assessment of spontaneity, evaluating feelings and thoughts that people experience in different daily situations. It includes 18 items, scored on a 5-point Likert scale. Higher total scores indicate higher levels of spontaneity (score range: 18-90)
  measure: Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of dermatological lesions related to vitiligo and any re-pigmentation
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: The Vitiligo Extent Score (VES) will be administered. The VES will be administered at Time 0 in order to evaluating the extent of vitiligo, and at Time 1 to evaluate any repigmentation. The VES is a template of vitiligo images that measures vitiligo at 19 different areas of the body. The physician has to score these 19 body areas separately by selecting the image that most resembles to patient's clinical in that body area, ranging from no lesion to almost 100% lesion coverage.
  measure: Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of personal perception of the patient
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: The Self Administered version of Vitiligo Extent score (SA-VES) will be administered. The SA-VES is a patient-reported outcome measurement instrument that is similar to the VES (it includes only 12 areas). It will be self- administered at Time 0 in order to evaluating the extent of vitiligo, and at Time 1 to evaluate any repigmentation.
  measure: Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of quality of life associated with the skin condition
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: Skindex-29, a three-dimensional, dermatology-specific Health-related quality of life questionnaire, will be administered. Skindex-29 items are combined to form three domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, with higher scores indicating lower levels of quality of life.
  measure: Multidimensional improvement of vitiligo
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: An adaptation of the Vitiligo Questionnaire ITA 4.0 will be administered. The Vitiligo Questionnaire ITA 4.0 measures several aspects of health status in vitiligo patients. It is self-administered and features thirty questions in five sections. These cover biologic factors, symptom status, functional status, treatment outcome perception, and economic impact.
  measure: Improvement of other autoimmune diseases, in terms of levels of levels of Thyroid Stimulating Hormone
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: Blood chemistry tests will be conducted to assess levels of Thyroid Stimulating Hormone (TSH), a pituitary thyroid-stimulating hormone that regulates thyroid activity. Reference values are 0.2-4.5 mU/L. Higher values may indicate thyroid hormone deficiency, lower levels may indicate thyroid hormone excess.
  measure: Improvement of other autoimmune diseases, in terms of levels of S-Free T4-Thyroxine
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: Blood chemistry tests will be conducted to assess levels of S-Free T4-Thyroxine (FT4), a thyroid hormone that regulates the body's metabolism, secretion of which is controlled by thyroid-stimulating hormone (TSH) produced by the pituitary gland. Reference values are 12.0 - 22.0 pmol/L. Higher values may indicate hyperthyroidism, lower levels may indicate hypothyroidism.
  measure: Improvement of other autoimmune diseases, in terms of levels of Anti Thyroglobulin
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: Blood chemistry tests will be conducted to assess levels of Anti Thyroglobulin (HTG), antibodies produced against thyroglobulin, a precursor protein of thyroid hormones triiodothyronine (FT3) and free thyroxine (FT4), indicating autoimmune pathology. Threshold value is 115 IU/ml; higher values may indicate possible development of hypothyroidism.
  measure: Improvement of other autoimmune diseases, in terms of levels of Anti Thyroperoxidase
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: Blood chemistry tests will be conducted to assess levels of Anti Thyroperoxidase (TPO), an antibody which, attacking the enzyme peroxidase, identifying autoimmune thyroid disease.
  Threshold value is 34 IU/ml; higher values may be associated with either hyperthyroidism or hypothyroidism (depending on whether it's Graves' disease or Hashimoto's thyroiditis).
  measure: Improvement of other autoimmune diseases, in terms of levels of Antinuclear Antibodies
  time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
  description: Blood chemistry tests will be conducted to assess levels of Antinuclear Antibodies (ANA), antibodies produced by the body's immune system, indicating the presence of autoantibodies in circulating blood.
  Threshold value is 1:160.
  arm group label: Psychodramatic Psychotherapy
  arm group type: Experimental
  description: This experimental arm will include 12 patients with vitiligo (randomly assigned to this arm), attending the dermatology services of APSS Trento.
  This experimental group will receive the drug treatment usually recommended for vitiligo, in addition to 6 months of psychodramatic psychotherapy.
  arm group label: Self-help activities
  arm group type: Active Comparator
  description: This is a control arm which will include 12 patients with vitiligo (randomly assigned to this arm), attending the dermatology services of APSS Trento. This control group will receive the drug treatment usually recommended for vitiligo, in addition to 6 months of self-help activities.
  intervention type: Behavioral
  intervention name: Psychodramatic psychotherapy
  description: The psychodramatic psychotherapy will include a total of 14 meetings during a 6 months period and they will be held in presence (or remotely in case of COVID-19 government restrictions) as follows:
  1 individual motivational interview;
  1 weekly group session lasting 2 hours for 1 month (total 4 meetings);
  1 group session every 15 days lasting 2 hours, for 5 months (total 10 meetings).
  Patients will also receive the pharmacological treatment usually recommended for vitiligo.
  arm group label: Psychodramatic Psychotherapy
  intervention type: Behavioral
  intervention name: Self-help activities
  description: The self-help activities will include:
  1 individual motivational interview;
  1 weekly, 2 hours group meeting, for 1 month (total 4 meetings);
  1 group meeting lasting 2 hours every 15 days, for 5 months (total 10 meetings).
  Patients will also receive pharmacological treatment usually recommended for vitiligo.
  arm group label: Self-help activities
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: No
  last name: Gabriella Pravatà, MD
  role: Principal Investigator
  affiliation: APSS Trento
  last name: Gabriella Pravatà, MD
  phone: +393396749999
  email: gabriella.pravata@apss.tn.it
  facility: 
  contact: 
  country: Italy
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  citation: Taneja K, Taneja J, Kaur C, Patel S, Haldar D. Lipid Risk Factors in Vitiligo: Homocysteine the Connecting Link? Clin Lab. 2020 Oct 1;66(10). doi: 10.7754/Clin.Lab.2020.200120.
  PMID: 33073941
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  PMID: 15210457
  citation: Papadopoulos L, Bor R, Legg C, Hawk JL. Impact of life events on the onset of vitiligo in adults: preliminary evidence for a psychological dimension in aetiology. Clin Exp Dermatol. 1998 Nov;23(6):243-8. doi: 10.1046/j.1365-2230.1998.00384.x.
  PMID: 10233617
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  PMID: 12707482
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  PMID: 16405601
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  PMID: 686757
  citation: Porter J, Beuf AH, Nordlund JJ, Lerner AB. Psychological reaction to chronic skin disorders: a study of patients with vitiligo. Gen Hosp Psychiatry. 1979 Apr;1(1):73-7. doi: 10.1016/0163-8343(79)90081-1.
  PMID: 499777
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  PMID: 27328922
  citation: Shenefelt PD. Mindfulness-Based Cognitive Hypnotherapy and Skin Disorders. Am J Clin Hypn. 2018 Jul;61(1):34-44. doi: 10.1080/00029157.2017.1419457.
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  citation: Shah R, Hunt J, Webb TL, Thompson AR. Starting to develop self-help for social anxiety associated with vitiligo: using clinical significance to measure the potential effectiveness of enhanced psychological self-help. Br J Dermatol. 2014 Aug;171(2):332-7. doi: 10.1111/bjd.12990. Epub 2014 Aug 4.
  PMID: 24665869
  citation: Papadopoulos L, Bor R, Legg C. Coping with the disfiguring effects of vitiligo: a preliminary investigation into the effects of cognitive-behavioural therapy. Br J Med Psychol. 1999 Sep;72 ( Pt 3):385-96. doi: 10.1348/000711299160077.
  PMID: 10524722
  citation: Picardi A, Abeni D, Melchi CF, Puddu P, Pasquini P. Psychiatric morbidity in dermatological outpatients: an issue to be recognized. Br J Dermatol. 2000 Nov;143(5):983-91. doi: 10.1046/j.1365-2133.2000.03831.x.
  PMID: 11069507
  citation: Osinubi O, Grainge MJ, Hong L, Ahmed A, Batchelor JM, Grindlay D, Thompson AR, Ratib S. The prevalence of psychological comorbidity in people with vitiligo: a systematic review and meta-analysis. Br J Dermatol. 2018 Apr;178(4):863-878. doi: 10.1111/bjd.16049. Epub 2018 Feb 7.
  PMID: 28991357
  citation: Ramakrishna P, Rajni T. Psychiatric morbidity and quality of life in vitiligo patients. Indian J Psychol Med. 2014 Jul;36(3):302-3. doi: 10.4103/0253-7176.135385. Erratum In: Indian J Psychol Med. 2015 Jan-Mar;37(1):111.
  PMID: 25035556
  citation: Simons RE, Zevy DL, Jafferany M. Psychodermatology of vitiligo: Psychological impact and consequences. Dermatol Ther. 2020 May;33(3):e13418. doi: 10.1111/dth.13418. Epub 2020 May 4.
  PMID: 32297399
  citation: Cupertino F, Niemeyer-Corbellini JP, Ramos-E-Silva M. Psychosomatic aspects of vitiligo. Clin Dermatol. 2017 May-Jun;35(3):292-297. doi: 10.1016/j.clindermatol.2017.01.001. Epub 2017 Jan 21.
  PMID: 28511827
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  citation: Orkibi H, Feniger-Schaal R. Integrative systematic review of psychodrama psychotherapy research: Trends and methodological implications. PLoS One. 2019 Feb 19;14(2):e0212575. doi: 10.1371/journal.pone.0212575. eCollection 2019.
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  citation: Moreno TZ. To dream again (p.257). 2012; Ed.Mental Health Resources
  citation: Ron Y. Psychodrama's Role in Alleviating Acute Distress: A Case Study of an Open Therapy Group in a Psychiatric Inpatient Ward. Front Psychol. 2018 Oct 30;9:2075. doi: 10.3389/fpsyg.2018.02075. eCollection 2018.
  PMID: 30425674
  citation: Croce EB. La realtà in gioco. Reale e realtà in psicodramma analitico. 2001; Rome, Italy: Borla.
  citation: Kipper DA, Ritchie TD. The effectiveness of psychodramatic techniques: a meta-analysis. Group Dynamics: Theory, Research and Practice 2003; 7(1): 13-25.
  citation: Qureshi AA, Awosika O, Baruffi F, Rengifo-Pardo M, Ehrlich A. Psychological Therapies in Management of Psoriatic Skin Disease: A Systematic Review. Am J Clin Dermatol. 2019 Oct;20(5):607-624. doi: 10.1007/s40257-019-00437-7.
  PMID: 30937679
  citation: Erbay LG, Reyhani I, Unal S, Ozcan C, Ozgocer T, Ucar C, Yildiz S. Does Psychodrama Affect Perceived Stress, Anxiety-Depression Scores and Saliva Cortisol in Patients with Depression? Psychiatry Investig. 2018 Oct;15(10):970-975. doi: 10.30773/pi.2018.08.11.2. Epub 2018 Oct 11.
  PMID: 30301307
  citation: Gulassa D, Amaral R, Oliveira E, Tavares H. Group therapy for excoriation disorder: Psychodrama versus support therapy. Ann Clin Psychiatry. 2019 May;31(2):84-94.
  PMID: 31046029
  responsible party type: Principal Investigator
  investigator affiliation: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento
  investigator full name: Gabriella Pravata
  investigator title: Medical Doctor, Dermatologist
  mesh term: Vitiligo
  sharing ipd: No