Mental Health Associations With Vitiligo

Completed

• Conditions: Anxiety Disorders; Adjustment Disorders; Depressive Episode; Overdose; Parasuicide; Recurrent Depressive Disorder; Substance Abuse; Suicide, Attempted; Vitiligo; Social Phobia
• Interventions: Other: Exposure of mental health condtion of interest

• Registration Number: NCT04953338
• Lead Sponsor: Momentum Data

Brief Summary

This cohort study is a large population-based study in the UK to determine the risks of comorbid mental health conditions (including depression, anxiety and other potential psychological complications of vitiligo) in adults with vitiligo compared to controls and to evaluate whether the relative risks may vary by different ethnicity.

Detailed Description

This study has two primary outcomes 1) Prevalence and incidence of mental health condtions in people diagnosed with vitiligo compared to matched controls and 2) Primary care and secondary healthcare utilisation in patients diagnosed with vitiligo and having a prevalent depressive conditon compared to matched controls. In addition, the study examines risk of time off work and unemployment in people diagnosed with vitiligo compared to matched controls.

Study Timeline

• Study Start: 2021-06-18
• Study First Submitted: 2021-06-19
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-07
• Status Verified: 2022-01
• Primary Completion: 2022-08-30
• Study Completion: 2022-10-21
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45000

Inclusion Criteria

• All eligible adults ≥18 (as at date of vitiligo diagnosis for cases or start of follow-up for controls) registered with GP practices contributing data to OPCRD between January 1, 2004 and December 31, 2020, were eligible for inclusion in the study.

Exclusion Criteria

• People with less than 1 year of follow up available

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Exposure of mental health condtion of interest	Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.
Controls	Exposure of mental health condtion of interest	The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level.

Primary Outcome Measures

Name	Time	Method
Describe the prevalence of common mental health conditions in adults diagnosed with vitiligo and matched controls without vitiligo	At the time of diagnosis in all people diagnosed with vitiligo 2004-2020 inclusive. For matched controls, the date of diagnosis of their matched case.	Prevalence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult people diagnosed with vitiligo.
Describe the incidence of common mental health conditions in adults diagnosed with vitiligo and matched controls without vitiligo	Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.	Incidence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult people with vitiligo in a contemporary real-world population compared with matched controls.
Describe mental health management patterns in adults with vitiligo and mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder)	Within one year of vitiligo diagnosis. For matched controls, within one year of the date of diagnosis of their matched case.	Mental health management comprises of referrals for cognitive behavioural therapy, counselling, psychotherapy, psychiatry, and other psychological intervention either through direct referral or the Improving Access to Psychological Therapies (IAPT) services programme.
Describe other potential psychological complications in adult people diagnoses with vitiligo and matched controls without vitiligo	Within one year of vitiligo diagnosis.	Psychological complications comprises of social phobia, adjustment disorder, substance abuse, self-harm, overdose, and parasuicide or suicide attempts.
Describe the burden of 'sick days' and unemployment in adult people of normal working age diagnosed with vitiligo and matched controls without vitiligo	Within one year of vitiligo diagnosis.	Sick days will be indicated by the issuing of Med 3 certification from primary care (Statement of Fitness for Work) certification. Unemployment will be identified using Read codes relating to unemployment recorded in the clinical record or the issuing of an Incapacity Benefit (IB113) or Employment and Support Allowance (ESA113) form. Normal working age is defined as aged 18 - 65 years.
Describe healthcare utilisation in adults with incident (new onset) vitiligo and matched controls without vitiligo	Within one year of vitiligo diagnosis. For matched controls, within one year of the date of diagnosis of their matched case.	Healthcare utilisation comprises of number of primary care visits.

Secondary Outcome Measures

Name	Time	Method
Describe the incidence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult people with vitiligo stratified by sociodemographic factors compared to matched controls.	Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.	Sociodemographic groups are defined by 10-year age category, sex, socio-economic status and ethnicity.

Trial Locations

Locations (1)

Momentum Data Ltd; 🇬🇧 London, United Kingdom