Vitiligo and Psychodrama Therapy

Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento

Status: Completed

Conditions: Vitiligo

Treatments: Behavioral: Psychodramatic psychotherapy; Behavioral: Self-help activities

Study type: Interventional

Funder types: Other

Identifiers

NCT05991596

A800

Details and patient eligibility

About

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.

Full 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).

Enrollment: 7 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Psychodramatic Psychotherapy

Experimental group

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.

Treatment:

Behavioral: Psychodramatic psychotherapy

Self-help activities

Active Comparator group

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.

Treatment:

Behavioral: Self-help activities