Study Results
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Basic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2023-11-02
2024-05-11
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Psychodramatic Psychotherapy
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.
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.
Self-help activities
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
* Individual and/or group psychotherapy in progress.
* Have previously received other psychotherapy.
* Use of psychiatric drugs in the last 3 months.
18 Years
55 Years
ALL
No
Sponsors
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Università degli Studi di Brescia
OTHER
Scuola Psicoterapia Psicodrammatica Brescia
UNKNOWN
Università degli Studi di Trento
OTHER
Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento
OTHER
Responsible Party
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Gabriella Pravata
Medical Doctor, Dermatologist
Principal Investigators
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Gabriella Pravatà, MD
Role: PRINCIPAL_INVESTIGATOR
APSS Trento
Locations
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APSS Trento
Trento, , Italy
Countries
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References
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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.
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.
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.
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.
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Other Identifiers
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A800
Identifier Type: -
Identifier Source: org_study_id
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