Clinical trial NCT06802705: Psychosocial Stress on QOL in Saudi Arabian Patients with Alopecia Areata
Official title: The Impact of Psychosocial Stress on Quality of Life in Saudi Arabian Patients with Alopecia Areata
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alopecia Areata
Keywords: Alopecia Areata
Hair Loss
Autoimmune Disorder
Dermatological Conditions
Lead sponsor: University of Jeddah
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 398
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study population consisted of Alopecia areata patients in Saudi Arabia of both genders. Saudi and non-Saudi patients with Alopecia areata in Saudi Arabia who were at least 16 years old, of both sexes, and with all clinical forms of AA met the inclusion criteria. Patients who are below 16 years old and who were ineligible due to medical reasons, and those who had any concomitant chronic dermatological problems, were excluded.

Brief summary: Background: Alopecia areata (AA) is an autoimmune disorder that causes non-scaring hair loss, and common psychiatric comorbidities such as depression and anxiety are often experienced among these patients. The underlying causes of this disorder, including environmental factors, immune responses, autoimmune reactions, and genetic predisposition, are still debated. This condition affects approximately 0.2% of the global population and has no specific gender preference, with an average onset age of 33 years. This study aims to assess the psychosocial impact on quality of life in individuals with alopecia areata in Saudi Arabia Methodology: This study employed a cross-sectional questionnaire survey among Alopecia areata patients, targeting both Saudi and non-Saudi participants of both genders, from October 2023 - March 2024. The sample size is determined to be 384 participants based on a confidence level of 95%. By investigating the psychological impact of AA in Saudi Arabia.

Detailed description: Introduction:

Hair loss is the main symptom of Alopecia areata (AA), which is caused by an autoimmune process. The pathophysiology of this disease is frequently debated; the most prevalent topics are factors related to the environment, non-specific immune responses, organ-specific autoimmune reactions, and genetic background. Furthermore, psychiatric comorbidities such as depression, anxiety, social phobia, and personality problems are very common among AA patients. Alopecia areata, which affects 0.2% of people globally, causes non-scarring hair loss. There is no obvious gender preference, and the typical age of onset is 33 years. Unpredictability exists in the disease's progression. 34-50% of patients will demonstrate spontaneous recovery 1 year after the disease's beginning, according to earlier research. According to other research, up to 80% of patients would make a full recovery after a year; however, 15-25% of patients would lose all of their body and/or head hair, and fewer than 10% of these patients would make a full recovery. Patients with dermatological conditions are far more likely to have psychiatric diseases. It has been estimated that 25% to 43% of patients visiting dermatological clinics have psychological illnesses. Studies have indicated that people with alopecia are more likely to experience psychological disorders throughout their lifespan, such as severe depression (39%) and generalized anxiety disorder (39%). Looking at the literature, research done in Makkah revealed that a considerable 79.6% of participants said that AA had a detrimental impact on one's psychological well-being. Anxiety (47.9%), depression (36.0%), and feeling criticized in front of others (63.0%) were the most prevalent psychological effects of AA. Furthermore, a study by " Abideen F" showed that in 70% of cases, the quality of life measured by the DLQI score was affected, and a history of stress was associated with 28 of the 60 patients with AA, and 17 of them suffered from psychiatric illness. Another study was done by Suchana et al (2020), aimed to investigate depression and anxiety in patients with alopecia areata, According to the study's results, anxiety and depression were both common in 75 individuals, with respective prevalence rates of 66.7% and 73.3%. Due to insignificant number of published studies that focus on the psychosocial impact of alopecia areata among patients in Saudi Arabia, Consequently, exploring this area of study is highly recommended. This study aims to assess the psychosocial impact on quality of life in individuals with alopecia areata in Saudi Arabia

Materials and Methods:

Study design: This study was a cross-sectional questionnaire survey, based on a structured questionnaire that was developed by the authors, conducted among Alopecia areata patients in Saudi Arabia.

Study setting: Participants, recruitment, and sampling procedure: This study population consisted of Alopecia areata patients in Saudi Arabia of both genders from October 2023 - March 2024.

Inclusion and Exclusion criteria:

Saudi and non-Saudi patients with Alopecia areata in Saudi Arabia who were at least 16 years old, of both sexes, and with all clinical forms of AA met the inclusion criteria. Patients who are below 16 years old and who were ineligible due to medical reasons, and those who had any concomitant chronic dermatological problems, were excluded.

Sample size:

Using the Raosoft calculator, a sample size of 384 was estimated with a confidence level of 95%. The size of the sample was calculated by using formula: n= P (1-P) \* Zα 2

/ d 2with a 95 % confidence level. n: Calculated sample size Z: The z-value for the selected level of confidence (1- a) = 1.96. P: An estimated prevalence of knowledge Q: (1 - 0.50) = 50%, i.e., 0.50 D: The maximum acceptable error = 0.05. So, the calculated minimum sample size was: n = (1.96)2 X 0.50 X 0.50/ (0.05) 2 = 384.

Method for data collection and instrument (Data collection Technique and tools):

A structured questionnaire was used as a study tool. This questionnaire was developed from previous studies on the same topic, with permission obtained from the authors. The questionnaire consisted of 25 questions divided into four sections. Section 1 focused on socio-demographic characteristics and consisted of 9 questions. Section 2 assessed disease diagnosis and management approaches with 6 questions. Section 3 evaluated the psychological impact of the patients with 5 questions. Section 4 examined the quality of life of the patients with 5 questions.

In Section 1, participants were asked about their gender, age, nationality, place of residence, educational level, social status, family history of alopecia areata, sources of knowledge about alopecia areata, and type of alopecia they have. Section 2 included questions about when the disease was diagnosed, the onset of the disease, the method of diagnosis, referral to a dermatology clinic, and methods used to treat alopecia areata. Section 3 consisted of Yes/No questions and one multiple-choice question to assess the patient's feelings. Finally, Section 4 contained questions to assess the impact of alopecia areata on the patient's daily activities, such as work/school attendance, shopping habits, gardening activities, or home maintenance.

Scoring system: The authors have created a scoring system for analysis of participants response. In our survey, participants were asked about Psychosocial Stress on Quality of Life in Individuals with Alopecia areata. Each question had four valid answers. Each answer had its respective score, "Never 0, sometimes=1, usually=2, always=3". The cumulative score of the response was used to classify the participant into a risk category, "Low risk =1-6, Moderate risk =7-9, High risk =10-12".

The validated questionnaire, which was collected from a number of identical research studies and shown in the appendix, was used to evaluate Psychosocial Stress on Quality of Life in Individuals with Alopecia areata as our methodology describes.

Analyzes and entry method: Data was entered on the computer using the "Microsoft Office Excel Software" program (2016) for windows. Data was then transferred to the Statistical Package of Social Science Software (SPSS) program, version 20 (IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp.) to be statistically analyzed.

Eligibility criteria: Inclusion Criteria:

* Saudi and non-Saudi patients with Alopecia areata in Saudi Arabia who were at least 16 years old, of both sexes, and with all clinical forms of AA met the inclusion criteria.

Exclusion Criteria:

* Patients who are below 16 years old and who were ineligible due to medical reasons, and those who had any concomitant chronic dermatological problems, were excluded.

Primary outcomes:
measure: The Impact of Psychosocial Stress on Quality of Life in Saudi Arabian Patients with Alopecia Areata
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Saud Aleissa
Study officials:
affiliation: MD FAAD, Assistant Professor, King Abdulaziz University and University Hospital, Jeddah, Saudi Arabia.
name: Saud Aleissa
role: PRINCIPAL_INVESTIGATOR
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