Vitiligo and Psychodrama Therapy

NCT05991596 | Completed

• 1 other identifier: A800
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (5)

• Improvement of the levels of psychological distress of patients with vitiligo

  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.

  Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention

• Improvement of the levels of psychological distress of patients with vitiligo, in terms of psychological, functional or physical state.

  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).

  Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention

• Improvement of the levels of psychological distress of patients with vitiligo, in terms of anxiety symptoms

  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.

  Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention

• Improvement of the levels of psychological distress of patients with vitiligo, in terms of depressive symptoms

  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.

  Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention

• Improvement of the levels of psychological distress of patients with vitiligo, in terms of spontaneity

  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)

  Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention

Secondary Outcomes (9)

• Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of dermatological lesions related to vitiligo and any re-pigmentation

  Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention

• Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of personal perception of the patient

  Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention

• Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of quality of life associated with the skin condition

  Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention

• Multidimensional improvement of vitiligo

  Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention

• Improvement of other autoimmune diseases, in terms of levels of levels of Thyroid Stimulating Hormone

  Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention

Study Arms (2)

Psychodramatic Psychotherapy

EXPERIMENTAL

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.

Behavioral: Psychodramatic psychotherapy

Self-help activities

ACTIVE COMPARATOR

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.

Behavioral: Self-help activities

Interventions

Psychodramatic psychotherapy BEHAVIORAL

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.

Psychodramatic Psychotherapy

Self-help activities BEHAVIORAL

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.

Self-help activities

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Segmental vitiligo with unilateral localization.
• Non-segmental vitiligo (acrofacial; mucosal with more than one side affected; generalized universal; mixed associated with segmental vitiligo).
• Vitiligo-associated autoimmune comorbidity referred to in points 1-2: Thyroiditis.
• Symptoms of depression and/or anxiety and/or low self-esteem associated with Vitiligo mentioned in points 1-2.

You may not qualify if:

• Cognitive impairment/dementia (clinically diagnosed).
• Individual and/or group psychotherapy in progress.
• Have previously received other psychotherapy.
• Use of psychiatric drugs in the last 3 months.

Sponsors & Collaborators

• Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento: lead
• Università degli Studi di Brescia: collaborator
• Scuola Psicoterapia Psicodrammatica Brescia: collaborator
• Università degli Studi di Trento: collaborator

Study Sites (1)

APSS Trento

Trento, Italy

Location

Related Publications (32)

• Bassi R. Psiche e pelle. Introduzione alla dermatologia psicosomatica. 2006; Ed. Bollati Boringheri, Torino.

  BACKGROUND

• Bottaccioli F, Bottaccioli MG. Psiconeuroendocrinoimmunologia e scienza della cura integrata (pp 197-203; 203-210). 2017; Ed. Edra.

  BACKGROUND

• Bottaccioli F. Epigenetica e PNEI. 2016; Ed. Edra.

  BACKGROUND

• Arck PC, Slominski A, Theoharides TC, Peters EM, Paus R. Neuroimmunology of stress: skin takes center stage. J Invest Dermatol. 2006 Aug;126(8):1697-704. doi: 10.1038/sj.jid.5700104.

  PMID: 16845409 BACKGROUND

• Chapman BP, Moynihan J. The brain-skin connection: role of psychosocial factors and neuropeptides in psoriasis. Expert Rev Clin Immunol. 2009 Nov;5(6):623-7. doi: 10.1586/eci.09.56. No abstract available.

  PMID: 20477685 BACKGROUND

• Alhetheli GI. The Impact of Vitiligo on Patients' Psychological Status and Sexual Function: Cross-Sectional Questionnaire-Based Study. The Open Dermatology Journal. 2021; 15: 23-30.

  BACKGROUND

• 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 BACKGROUND

• Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677.

  PMID: 15210457 BACKGROUND

• 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 BACKGROUND

• Picardi A, Pasquini P, Cattaruzza MS, Gaetano P, Melchi CF, Baliva G, Camaioni D, Tiago A, Abeni D, Biondi M. Stressful life events, social support, attachment security and alexithymia in vitiligo. A case-control study. Psychother Psychosom. 2003 May-Jun;72(3):150-8. doi: 10.1159/000069731.

  PMID: 12707482 BACKGROUND

• Ongenae K, Beelaert L, van Geel N, Naeyaert JM. Psychosocial effects of vitiligo. J Eur Acad Dermatol Venereol. 2006 Jan;20(1):1-8. doi: 10.1111/j.1468-3083.2005.01369.x.

  PMID: 16405601 BACKGROUND

• Porter J, Beuf A, Nordlund JJ, Lerner AB. Personal responses of patients to vitiligo: the importance of the patient-physician interaction. Arch Dermatol. 1978 Sep;114(9):1384-5. No abstract available.

  PMID: 686757 BACKGROUND

• 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 BACKGROUND

• Ezzedine K, Silverberg N. A Practical Approach to the Diagnosis and Treatment of Vitiligo in Children. Pediatrics. 2016 Jul;138(1):e20154126. doi: 10.1542/peds.2015-4126. Epub 2016 Jun 21.

  PMID: 27328922 BACKGROUND

• 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.

  PMID: 29771216 BACKGROUND

• 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 BACKGROUND

• 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(3):385-96. doi: 10.1348/000711299160077.

  PMID: 10524722 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 25035556 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Moreno JL. Manuale di Psicodramma Vol. I e Vol. II. 1987; Ed. Astrolabio

  BACKGROUND

• 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.

  PMID: 30779787 BACKGROUND

• Akinsola EF, Udoka PA. Parental influence on social anxiety in children and adolescents: Its assessment and management using psychodrama. Psychology. 2013; 4(3):246-53.

  BACKGROUND

• Moreno TZ. To dream again (p.257). 2012; Ed.Mental Health Resources

  BACKGROUND

• 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 BACKGROUND

• Croce EB. La realtà in gioco. Reale e realtà in psicodramma analitico. 2001; Rome, Italy: Borla.

  BACKGROUND

• Kipper DA, Ritchie TD. The effectiveness of psychodramatic techniques: a meta-analysis. Group Dynamics: Theory, Research and Practice 2003; 7(1): 13-25.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gabriella Pravatà, MD

  APSS Trento

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Dermatologist

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: November 2, 2023
• Primary Completion: May 11, 2024
• Study Completion: May 11, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)