Clinical trial NCT04953338: Mental Health Associations With Vitiligo
Official title: The Mental Health Associations With Vitiligo: a Population-based Cohort Study in the UK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitiligo
Depressive Episode
Recurrent Depressive Disorder
Anxiety Disorders
Social Phobia
Adjustment Disorders
Substance Abuse
Self-Harm, Deliberate
Overdose
Suicide, Attempted
Parasuicide
Lead sponsor: Momentum Data
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2021-07-07
Enrollment: 45000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will use routinely collected and collated data from OPCRD to provide a broadly representative sample of the population of the UK.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Describe the prevalence of common mental health conditions in adults diagnosed with vitiligo and matched controls without vitiligo
timeFrame: 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.
measure: Describe the incidence of common mental health conditions in adults diagnosed with vitiligo and matched controls without vitiligo
timeFrame: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
measure: Describe healthcare utilisation in adults with incident (new onset) vitiligo and matched controls without vitiligo
timeFrame: Within one year of vitiligo diagnosis. For matched controls, within one year of the date of diagnosis of their matched case.
measure: Describe mental health management patterns in adults with vitiligo and mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder)
timeFrame: Within one year of vitiligo diagnosis. For matched controls, within one year of the date of diagnosis of their matched case.
measure: Describe the burden of 'sick days' and unemployment in adult people of normal working age diagnosed with vitiligo and matched controls without vitiligo
timeFrame: Within one year of vitiligo diagnosis.
measure: Describe other potential psychological complications in adult people diagnoses with vitiligo and matched controls without vitiligo
timeFrame: Within one year of vitiligo diagnosis.
Secondary outcomes:
measure: 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.
timeFrame: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Momentum Data Ltd
Study officials:
affiliation: Momentum Data Ltd
name: Andrew McGovern, MD
role: STUDY_DIRECTOR
References: