Vitiligo and Psychodrama Therapy

Vitiligo Clinical Trial

Official title: Vitiligo and Psychological Distress: Pilot Study for the Experimentation of a Psychodramatic Psychotherapy Treatment

Status Completed

Clinical Trial 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. 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.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Vitiligo

• NCT number: NCT05991596
• Study type: Interventional
• Source: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento
• Status: Completed
• Phase: N/A
• Start date: November 2, 2023
• Completion date: May 11, 2024