Psychosocial Stress on QOL in Saudi Arabian Patients with Alopecia Areata

January 25, 2025 updated by: Sultana Naif Kadasa, University of Jeddah

The Impact of Psychosocial Stress on Quality of Life in Saudi Arabian Patients with Alopecia Areata

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Impact of Psychosocial Stress on Quality of Life in Saudi Arabian Patients with Alopecia Areata
Time Frame: Baseline

For this study, sociodemographic characteristics of the participants, sources of information about alopecia areata, determinants of alopecia areata, levels of psychological stress, and the potential impact of psychological stress on the quality of life of alopecia areata patients will be presented using numbers and percentages.

The association between sociodemographic variables and the risk of psychological stress will be assessed using the chi-square test.

The significance level for this study is chosen before data collection, and is set to be lower than 5%.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jeddah

Investigators

  • Principal Investigator: Saud Aleissa, MD FAAD, Assistant Professor, King Abdulaziz University and University Hospital, Jeddah, Saudi Arabia.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 25, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QOL with Alopecia Areata

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alopecia Areata

Clinical Trials on Psychosocial Stress on Quality of Life

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe