Clinical trial NCT05991596: Vitiligo and Psychodrama Therapy
Official title: Vitiligo and Psychological Distress: Pilot Study for the Experimentation of a Psychodramatic Psychotherapy Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Lead sponsor: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Brescia
name: Scuola Psicoterapia Psicodrammatica Brescia
name: Università degli Studi di Trento
First posted: 2023-08-14
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of the levels of psychological distress of patients with vitiligo
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
measure: Improvement of the levels of psychological distress of patients with vitiligo, in terms of psychological, functional or physical state.
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
measure: Improvement of the levels of psychological distress of patients with vitiligo, in terms of anxiety symptoms
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
measure: Improvement of the levels of psychological distress of patients with vitiligo, in terms of depressive symptoms
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
measure: Improvement of the levels of psychological distress of patients with vitiligo, in terms of spontaneity
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Secondary outcomes:
measure: Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of dermatological lesions related to vitiligo and any re-pigmentation
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
measure: Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of personal perception of the patient
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
measure: Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of quality of life associated with the skin condition
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
measure: Multidimensional improvement of vitiligo
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
measure: Improvement of other autoimmune diseases, in terms of levels of levels of Thyroid Stimulating Hormone
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
measure: Improvement of other autoimmune diseases, in terms of levels of S-Free T4-Thyroxine
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
measure: Improvement of other autoimmune diseases, in terms of levels of Anti Thyroglobulin
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
measure: Improvement of other autoimmune diseases, in terms of levels of Anti Thyroperoxidase
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
measure: Improvement of other autoimmune diseases, in terms of levels of Antinuclear Antibodies
timeFrame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Other outcomes:
Locations:
city: Trento
country: Italy
facility: APSS Trento
Study officials:
affiliation: APSS Trento
name: Gabriella Pravatà, MD
role: PRINCIPAL_INVESTIGATOR
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