VitiligoNCT05991596
Vitiligo and Psychodrama Therapy
A study testing Psychodramatic psychotherapy and Self-help activities in people with Vitiligo, run by Azienda Sanitaria Universitaria Integrata del Trentino at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Psychodramatic psychotherapy and Self-help activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteItaly
- Study dates
- 2 Nov 2023to 11 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Segmental vitiligo with unilateral localization.
- Non-segmental vitiligo (acrofacial; mucosal with more than one side affected; generalized universal; mixed associated with segmental vitiligo).
- Vitiligo-associated autoimmune comorbidity referred to in points 1-2: Thyroiditis.
- Symptoms of depression and/or anxiety and/or low self-esteem associated with Vitiligo mentioned in points 1-2.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Vitiligo and Psychological Distress: Pilot Study for the Experimentation of a Psychodramatic Psychotherapy Treatment
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:
Read more
- Is there any improvement in terms of psychological distress in patients with vitiligo participating in a psychodramatic psychotherapy, compared to a control group?
- 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.
Read the 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
- Being tested
- Psychodramatic psychotherapy, Self-help activities
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychodramatic psychotherapyBehavioural
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 activitiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychodramatic Psychotherapy | Experimental | 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. Receives: Behavioral: Psychodramatic psychotherapy |
| Self-help activities | Active comparator | 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. Receives: Behavioral: Self-help activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the levels of psychological distress of patients with vitiligo
The General Health Questionnaire (GHQ-12), a self-administered questionnaire covering several domains associated with a person's psychological well-being, will be administered to all patients. Scoring is along a 4-point scale (total score ranging from 0 to 36) with higher scores suggestive of more distress.
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of the levels of psychological distress of patients with vitiligo, in terms of psychological, functional or physical state.
The Short-Form Health Survey (SF-36): a health status profile originally designed to measure health status and outcomes, will be administered to all patients. This instrument addresses health concepts from the patient's perspective and its 36 questions are meant to reflect 8 domains of health, evaluating any changes in the psychological, functional or physical state of patients. SF-36 scores range from 0 (worst) to 100 (best).
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of the levels of psychological distress of patients with vitiligo, in terms of anxiety symptoms
The Beck Anxiety Inventory (B.A.I.), a self-report measure of anxiety, will be administered to all patients. The BAI items are scored on a scale between 0 and 3 and have a maximum score of 63, with higher scores suggestive of higher levels of anxiety.
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of the levels of psychological distress of patients with vitiligo, in terms of depressive symptoms
The Beck Depression Inventory (B.D.I.), a 21-question multiple-choice self-report inventory and one of the most widely used instruments for measuring the severity of depression, will be administered to all patients. A value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. Higher total scores indicate more severe depressive symptoms.
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of the levels of psychological distress of patients with vitiligo, in terms of spontaneity
The Revised Spontaneity Assessment Inventory (SAI-R) will be administered to all patients. The SAI-R is a scale for the assessment of spontaneity, evaluating feelings and thoughts that people experience in different daily situations. It includes 18 items, scored on a 5-point Likert scale. Higher total scores indicate higher levels of spontaneity (score range: 18-90)
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Secondary outcomes (9)
Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of dermatological lesions related to vitiligo and any re-pigmentation
The Vitiligo Extent Score (VES) will be administered. The VES will be administered at Time 0 in order to evaluating the extent of vitiligo, and at Time 1 to evaluate any repigmentation. The VES is a template of vitiligo images that measures vitiligo at 19 different areas of the body. The physician has to score these 19 body areas separately by selecting the image that most resembles to patient's clinical in that body area, ranging from no lesion to almost 100% lesion coverage.
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of personal perception of the patient
The Self Administered version of Vitiligo Extent score (SA-VES) will be administered. The SA-VES is a patient-reported outcome measurement instrument that is similar to the VES (it includes only 12 areas). It will be self- administered at Time 0 in order to evaluating the extent of vitiligo, and at Time 1 to evaluate any repigmentation.
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of quality of life associated with the skin condition
Skindex-29, a three-dimensional, dermatology-specific Health-related quality of life questionnaire, will be administered. Skindex-29 items are combined to form three domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, with higher scores indicating lower levels of quality of life.
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Multidimensional improvement of vitiligo
An adaptation of the Vitiligo Questionnaire ITA 4.0 will be administered. The Vitiligo Questionnaire ITA 4.0 measures several aspects of health status in vitiligo patients. It is self-administered and features thirty questions in five sections. These cover biologic factors, symptom status, functional status, treatment outcome perception, and economic impact.
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of other autoimmune diseases, in terms of levels of levels of Thyroid Stimulating Hormone
Blood chemistry tests will be conducted to assess levels of Thyroid Stimulating Hormone (TSH), a pituitary thyroid-stimulating hormone that regulates thyroid activity. Reference values are 0.2-4.5 mU/L. Higher values may indicate thyroid hormone deficiency, lower levels may indicate thyroid hormone excess.
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of other autoimmune diseases, in terms of levels of S-Free T4-Thyroxine
Blood chemistry tests will be conducted to assess levels of S-Free T4-Thyroxine (FT4), a thyroid hormone that regulates the body's metabolism, secretion of which is controlled by thyroid-stimulating hormone (TSH) produced by the pituitary gland. Reference values are 12.0 - 22.0 pmol/L. Higher values may indicate hyperthyroidism, lower levels may indicate hypothyroidism.
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of other autoimmune diseases, in terms of levels of Anti Thyroglobulin
Blood chemistry tests will be conducted to assess levels of Anti Thyroglobulin (HTG), antibodies produced against thyroglobulin, a precursor protein of thyroid hormones triiodothyronine (FT3) and free thyroxine (FT4), indicating autoimmune pathology. Threshold value is 115 IU/ml; higher values may indicate possible development of hypothyroidism.
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of other autoimmune diseases, in terms of levels of Anti Thyroperoxidase
Blood chemistry tests will be conducted to assess levels of Anti Thyroperoxidase (TPO), an antibody which, attacking the enzyme peroxidase, identifying autoimmune thyroid disease.
Threshold value is 34 IU/ml; higher values may be associated with either hyperthyroidism or hypothyroidism (depending on whether it's Graves' disease or Hashimoto's thyroiditis).
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of other autoimmune diseases, in terms of levels of Antinuclear Antibodies
Blood chemistry tests will be conducted to assess levels of Antinuclear Antibodies (ANA), antibodies produced by the body's immune system, indicating the presence of autoantibodies in circulating blood.
Threshold value is 1:160.
Measured: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start2 Nov 2023
- Primary completion11 May 2024
- Study completion11 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Universitaria Integrata del Trentino
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Brescia, Scuola Psicoterapia Psicodrammatica Brescia, Università degli Studi di Trento
- Responsible party
- Principal investigator, Gabriella Pravata, Azienda Sanitaria Universitaria Integrata del Trentino
- Investigators
- Gabriella Pravatà, MD, Principal investigator, APSS Trento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991596
- Sponsor's protocol ID
- A800
- Status last verified
- Jun 2024
- First submitted
- 26 Jul 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bassi R. Psiche e pelle. Introduzione alla dermatologia psicosomatica. 2006; Ed. Bollati Boringheri, Torino.
Bottaccioli F, Bottaccioli MG. Psiconeuroendocrinoimmunologia e scienza della cura integrata (pp 197-203; 203-210). 2017; Ed. Edra.
Bottaccioli F. Epigenetica e PNEI. 2016; Ed. Edra.
Arck PC, Slominski A, Theoharides TC, Peters EM, Paus R. Neuroimmunology of stress: skin takes center stage. J Invest Dermatol. 2006 Aug;126(8):1697-704. doi: 10.1038/sj.jid.5700104.
PubMed 16845409Chapman BP, Moynihan J. The brain-skin connection: role of psychosocial factors and neuropeptides in psoriasis. Expert Rev Clin Immunol. 2009 Nov;5(6):623-7. doi: 10.1586/eci.09.56. No abstract available.
PubMed 20477685Alhetheli GI. The Impact of Vitiligo on Patients' Psychological Status and Sexual Function: Cross-Sectional Questionnaire-Based Study. The Open Dermatology Journal. 2021; 15: 23-30.
Taneja K, Taneja J, Kaur C, Patel S, Haldar D. Lipid Risk Factors in Vitiligo: Homocysteine the Connecting Link? Clin Lab. 2020 Oct 1;66(10). doi: 10.7754/Clin.Lab.2020.200120.
PubMed 33073941Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677.
PubMed 15210457Papadopoulos L, Bor R, Legg C, Hawk JL. Impact of life events on the onset of vitiligo in adults: preliminary evidence for a psychological dimension in aetiology. Clin Exp Dermatol. 1998 Nov;23(6):243-8. doi: 10.1046/j.1365-2230.1998.00384.x.
PubMed 10233617Picardi A, Pasquini P, Cattaruzza MS, Gaetano P, Melchi CF, Baliva G, Camaioni D, Tiago A, Abeni D, Biondi M. Stressful life events, social support, attachment security and alexithymia in vitiligo. A case-control study. Psychother Psychosom. 2003 May-Jun;72(3):150-8. doi: 10.1159/000069731.
PubMed 12707482Ongenae K, Beelaert L, van Geel N, Naeyaert JM. Psychosocial effects of vitiligo. J Eur Acad Dermatol Venereol. 2006 Jan;20(1):1-8. doi: 10.1111/j.1468-3083.2005.01369.x.
PubMed 16405601Porter J, Beuf A, Nordlund JJ, Lerner AB. Personal responses of patients to vitiligo: the importance of the patient-physician interaction. Arch Dermatol. 1978 Sep;114(9):1384-5. No abstract available.
PubMed 686757Porter J, Beuf AH, Nordlund JJ, Lerner AB. Psychological reaction to chronic skin disorders: a study of patients with vitiligo. Gen Hosp Psychiatry. 1979 Apr;1(1):73-7. doi: 10.1016/0163-8343(79)90081-1.
PubMed 499777Ezzedine K, Silverberg N. A Practical Approach to the Diagnosis and Treatment of Vitiligo in Children. Pediatrics. 2016 Jul;138(1):e20154126. doi: 10.1542/peds.2015-4126. Epub 2016 Jun 21.
PubMed 27328922Shenefelt PD. Mindfulness-Based Cognitive Hypnotherapy and Skin Disorders. Am J Clin Hypn. 2018 Jul;61(1):34-44. doi: 10.1080/00029157.2017.1419457.
PubMed 29771216
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitiligo and Psychological Distress: Pilot Study for the Experimentation of a Psychodramatic Psychotherapy Treatment
- ClinicalTrials.gov ID
- NCT05991596
- Acronym / sponsor ID
- A800
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Azienda Sanitaria Universitaria Integrata del TrentinoUniversity, hospital or other
- Collaborators
- Università degli Studi di Brescia, Scuola Psicoterapia Psicodrammatica Brescia, Università degli Studi di Trento
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is there any improvement in terms of psychological distress in patients with vitiligo participating in a psychodramatic psychotherapy, compared to a control group?
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychodramatic Psychotherapy | Experimental | Behavioral: Psychodramatic psychotherapyThis 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. |
| Self-help activities | Active comparator | Behavioral: Self-help activitiesThis 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Segmental vitiligo with unilateral localization.
- Non-segmental vitiligo (acrofacial; mucosal with more than one side affected; generalized universal; mixed associated with segmental vitiligo).
- Vitiligo-associated autoimmune comorbidity referred to in points 1-2: Thyroiditis.
- Symptoms of depression and/or anxiety and/or low self-esteem associated with Vitiligo mentioned in points 1-2.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychodramatic psychotherapyThe 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. | Behavioural | Psychodramatic Psychotherapy |
| Self-help activitiesThe 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. | Behavioural | Self-help activities |
Primary outcome
Improvement of the levels of psychological distress of patients with vitiligo
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
The General Health Questionnaire (GHQ-12), a self-administered questionnaire covering several domains associated with a person's psychological well-being, will be administered to all patients. Scoring is along a 4-point scale (total score ranging from 0 to 36) with higher scores suggestive of more distress.
Improvement of the levels of psychological distress of patients with vitiligo, in terms of psychological, functional or physical state.
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
The Short-Form Health Survey (SF-36): a health status profile originally designed to measure health status and outcomes, will be administered to all patients. This instrument addresses health concepts from the patient's perspective and its 36 questions are meant to reflect 8 domains of health, evaluating any changes in the psychological, functional or physical state of patients. SF-36 scores range from 0 (worst) to 100 (best).
Improvement of the levels of psychological distress of patients with vitiligo, in terms of anxiety symptoms
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
The Beck Anxiety Inventory (B.A.I.), a self-report measure of anxiety, will be administered to all patients. The BAI items are scored on a scale between 0 and 3 and have a maximum score of 63, with higher scores suggestive of higher levels of anxiety.
Improvement of the levels of psychological distress of patients with vitiligo, in terms of depressive symptoms
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
The Beck Depression Inventory (B.D.I.), a 21-question multiple-choice self-report inventory and one of the most widely used instruments for measuring the severity of depression, will be administered to all patients. A value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. Higher total scores indicate more severe depressive symptoms.
Improvement of the levels of psychological distress of patients with vitiligo, in terms of spontaneity
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
The Revised Spontaneity Assessment Inventory (SAI-R) will be administered to all patients. The SAI-R is a scale for the assessment of spontaneity, evaluating feelings and thoughts that people experience in different daily situations. It includes 18 items, scored on a 5-point Likert scale. Higher total scores indicate higher levels of spontaneity (score range: 18-90)
9 secondary outcomes
Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of dermatological lesions related to vitiligo and any re-pigmentation
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of personal perception of the patient
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of quality of life associated with the skin condition
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Multidimensional improvement of vitiligo
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of other autoimmune diseases, in terms of levels of levels of Thyroid Stimulating Hormone
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of other autoimmune diseases, in terms of levels of S-Free T4-Thyroxine
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of other autoimmune diseases, in terms of levels of Anti Thyroglobulin
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of other autoimmune diseases, in terms of levels of Anti Thyroperoxidase
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Improvement of other autoimmune diseases, in terms of levels of Antinuclear Antibodies
Time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- BackgroundBassi R. Psiche e pelle. Introduzione alla dermatologia psicosomatica. 2006; Ed. Bollati Boringheri, Torino.
- BackgroundBottaccioli F, Bottaccioli MG. Psiconeuroendocrinoimmunologia e scienza della cura integrata (pp 197-203; 203-210). 2017; Ed. Edra.
- BackgroundBottaccioli F. Epigenetica e PNEI. 2016; Ed. Edra.
- Background: PubMed 16845409Arck PC, Slominski A, Theoharides TC, Peters EM, Paus R. Neuroimmunology of stress: skin takes center stage. J Invest Dermatol. 2006 Aug;126(8):1697-704. doi: 10.1038/sj.jid.5700104.
- Background: PubMed 20477685Chapman BP, Moynihan J. The brain-skin connection: role of psychosocial factors and neuropeptides in psoriasis. Expert Rev Clin Immunol. 2009 Nov;5(6):623-7. doi: 10.1586/eci.09.56. No abstract available.
- BackgroundAlhetheli GI. The Impact of Vitiligo on Patients' Psychological Status and Sexual Function: Cross-Sectional Questionnaire-Based Study. The Open Dermatology Journal. 2021; 15: 23-30.
- Background: PubMed 33073941Taneja K, Taneja J, Kaur C, Patel S, Haldar D. Lipid Risk Factors in Vitiligo: Homocysteine the Connecting Link? Clin Lab. 2020 Oct 1;66(10). doi: 10.7754/Clin.Lab.2020.200120.
- Background: PubMed 15210457Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677.
- Background: PubMed 10233617Papadopoulos L, Bor R, Legg C, Hawk JL. Impact of life events on the onset of vitiligo in adults: preliminary evidence for a psychological dimension in aetiology. Clin Exp Dermatol. 1998 Nov;23(6):243-8. doi: 10.1046/j.1365-2230.1998.00384.x.
- Background: PubMed 12707482Picardi A, Pasquini P, Cattaruzza MS, Gaetano P, Melchi CF, Baliva G, Camaioni D, Tiago A, Abeni D, Biondi M. Stressful life events, social support, attachment security and alexithymia in vitiligo. A case-control study. Psychother Psychosom. 2003 May-Jun;72(3):150-8. doi: 10.1159/000069731.
- Background: PubMed 16405601Ongenae K, Beelaert L, van Geel N, Naeyaert JM. Psychosocial effects of vitiligo. J Eur Acad Dermatol Venereol. 2006 Jan;20(1):1-8. doi: 10.1111/j.1468-3083.2005.01369.x.
- Background: PubMed 686757Porter J, Beuf A, Nordlund JJ, Lerner AB. Personal responses of patients to vitiligo: the importance of the patient-physician interaction. Arch Dermatol. 1978 Sep;114(9):1384-5. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Vitiligo
RecruitingPhase 2
A Study to Learn How Safe ACT-777991 is and How Well it Works in Adults With Non-segmental Vitiligo
Non-Segmental Vitiligo
Enrolling by invitation
Topical Ruxolitinib Versus Tacrolimus With Excimer Laser for Localized Vitiligo
Vitiligo, Nonsegmental Vitiligo
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo
RecruitingPhase 2
Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
Non-segmental Vitiligo
Active, not recruiting
Plasma Exeresis Plus NB-UVB Versus NB-UVB Alone for Stable Vitiligo
Vitiligo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriella Pravatà, MD principal investigator
APSS Trento
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychodramatic psychotherapy and Self-help activities in people with Vitiligo, run by Azienda Sanitaria Universitaria Integrata del Trentino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the levels of psychological distress of patients with vitiligo (time frame: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05991596, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.