NCT05991596

Vitiligo and Psychodrama Therapy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Azienda Sanitaria Universitaria Integrata del Trentino · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Vitiligo

Interventions

Type	Name	Description
BEHAVIORAL	Psychodramatic psychotherapy	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.
BEHAVIORAL	Self-help activities	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.

Timeline

• Start date: 2023-11-02
• Primary completion: 2024-05-11
• Completion: 2024-05-11
• First posted: 2023-08-14
• Last updated: 2024-06-20

Locations

1 site across 1 country: Italy