Mental Health Associations With Vitiligo

Anxiety Disorders Clinical Trial

Official title:

The Mental Health Associations With Vitiligo: a Population-based Cohort Study in the UK

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04953338
• Other study ID #: P044
• Status: Completed
• Start date: June 18, 2021
• Est. completion date: October 21, 2022

Study information

• Verified date: January 2022
• Source: Momentum Data
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45000
• Est. completion date: October 21, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjustment Disorders
• Anxiety Disorders
• Depressive Disorder
• Depressive Episode
• Disease
• Overdose
• Parasuicide
• Phobia, Social
• Recurrent Depressive Disorder
• Self-Harm, Deliberate
• Self-Injurious Behavior
• Social Phobia
• Substance Abuse
• Substance-Related Disorders
• Suicide
• Suicide, Attempted
• Vitiligo

Intervention

Other:
• Exposure of mental health condtion of interest
Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder.

Locations

Country	Name	City	State
United Kingdom	Momentum Data Ltd	London

Sponsors (2)

Lead Sponsor	Collaborator
Momentum Data	Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the prevalence of common mental health conditions in adults diagnosed with vitiligo and matched controls without vitiligo	Prevalence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult people diagnosed with 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.
Primary	Describe the incidence of common mental health conditions in adults diagnosed with vitiligo and matched controls without vitiligo	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.	Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
Primary	Describe healthcare utilisation in adults with incident (new onset) vitiligo and matched controls without vitiligo	Healthcare utilisation comprises of number of primary care visits.	Within one year of vitiligo diagnosis. For matched controls, within one year of the date of diagnosis of their matched case.
Primary	Describe mental health management patterns in adults with vitiligo and mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder)	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.	Within one year of vitiligo diagnosis. For matched controls, within one year of the date of diagnosis of their matched case.
Primary	Describe the burden of 'sick days' and unemployment in adult people of normal working age diagnosed with vitiligo and matched controls without vitiligo	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.	Within one year of vitiligo diagnosis.
Primary	Describe other potential psychological complications in adult people diagnoses with vitiligo and matched controls without vitiligo	Psychological complications comprises of social phobia, adjustment disorder, substance abuse, self-harm, overdose, and parasuicide or suicide attempts.	Within one year of vitiligo diagnosis.
Secondary	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.	Sociodemographic groups are defined by 10-year age category, sex, socio-economic status and ethnicity.	Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.