Mental Health Associations With Vitiligo

Sponsor
Momentum Data (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04953338
Collaborator
Pfizer (Industry)
45,000
1
13.4
3348.9

Study Details

Study Description

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 Design

Study Type:
Observational
Actual Enrollment :
45000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Mental Health Associations With Vitiligo: a Population-based Cohort Study in the UK
Actual Study Start Date :
Jun 18, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Cases

Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.

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

Controls

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.

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Momentum Data Ltd London United Kingdom WC1X 8QT

Sponsors and Collaborators

  • Momentum Data
  • Pfizer

Investigators

  • Study Director: Andrew McGovern, MD, Momentum Data Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Momentum Data
ClinicalTrials.gov Identifier:
NCT04953338
Other Study ID Numbers:
  • P044
First Posted:
Jul 7, 2021
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2022