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. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

ISRCTN83649248.

Study name Improving the mental health and quality of life of people affected by leprosy or Buruli ulcer in Southern Nigeria
Methods Study design: RCT
Country: Nigeria
Participants People affected by leprosy or Buruli ulcer
Inclusion criteria: 
a. affected by leprosy or Buruli ulcer;
b. affected by leprosy or Buruli ulcer registered for treatment from 2014 up to 1 year before the end of the intervention;
c. aged between 15 to 65 years registered for treatment.
Exclusion criteria:
a. refusal to give consent;
b. pregnant women;
c. patients who need urgent medical attention;
d. patients unable to communicate clearly.
Stated purpose: the study proposes a holistic, community‐oriented approach for improving access and utilization of mental health services through interventions using holistic approach work synergistically to reduce mental disorders and improve quality of life amongst persons affected by leprosy or Buruli ulcer.
Interventions Intervention:
Holistic, community‐oriented approach
1. Engaging selected community members as lay counsellors to provide psychotherapy and counselling services for persons affected by leprosy or Buruli ulcer
2. Formation of self‐help groups (SHG) amongst persons affected by leprosy or Buruli ulcer for peer support and improving self‐esteem
3. Training of healthcare workers to provide pharmacological treatment or referral services to experts where necessary
The intervention phase will take about 1‐2 years with quarterly community sensitization during supervisory visits by the research team to promote social inclusion, raise awareness on mental health problems and availability of services to create demand and enhance utilization
Control:
No intervention
Outcomes Participants'outcomes of interest for this review

  1. Mental health symptoms/depression – Patient Health Questionnaire 9 (PHQ‐9)

  2. Mental health symptoms/anxiety – Generalized Anxiety Disorder‐7 (GAD‐7)

  3. Quality of life – World Health Organization Quality‐of‐Life Scale (WHOQOL‐BREF)

  4. Quality of life – Warwick‐Edinburgh Mental Wellbeing Scale (WEMWBS)

  5. Social outcome (social inclusion) – Social Distance Scale (SDS)


Economic outcomes
Nil
Time points: baseline, post‐intervention (after 2 years of intervention)
Starting date 01 June 2021 (first enrolment)
Contact information Ngozi Ekeke, ngozi.ekeke@dahw.org
Notes Source of funding: Leprosy Research Initiative (LRI)
Prospective trial registration number: ISRCTN83649248