Vitiligo and Psychodrama Therapy
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05991596 |
|
Recruitment Status :
Recruiting
First Posted : August 14, 2023
Last Update Posted : February 1, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vitiligo | Behavioral: Psychodramatic psychotherapy Behavioral: Self-help activities | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Vitiligo and Psychological Distress: Pilot Study for the Experimentation of a Psychodramatic Psychotherapy Treatment |
| Actual Study Start Date : | November 2, 2023 |
| Estimated Primary Completion Date : | May 31, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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. |
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:
Patients will also receive the pharmacological treatment usually recommended for vitiligo. |
|
Active Comparator: 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.
|
Behavioral: Self-help activities
The self-help activities will include:
Patients will also receive pharmacological treatment usually recommended for vitiligo. |
- 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)
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]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.
- 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 ]
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).
- 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 ]
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05991596
| Contact: Gabriella Pravatà, MD | +393396749999 | gabriella.pravata@apss.tn.it |
| Italy | |
| APSS Trento | Recruiting |
| Trento, Italy | |
| Contact: Gabriella Pravatà, MD +393396749999 gabriella.pravata@apss.tn.it | |
| Principal Investigator: | Gabriella Pravatà, MD | APSS Trento |
| Responsible Party: | Gabriella Pravata, Medical Doctor, Dermatologist, Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento |
| ClinicalTrials.gov Identifier: | NCT05991596 |
| Other Study ID Numbers: |
A800 |
| First Posted: | August 14, 2023 Key Record Dates |
| Last Update Posted: | February 1, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases |