The Impact of Lifestyle on Mental Health Among Young Men in the Gilgel Gibe Field Research Center, Ethiopia: Pilot Study

Psychotic Symptoms Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615652
• Other study ID #: University of Konstanz
• Status: Completed
• Phase: N/A
• First received: November 22, 2015
• Last updated: May 10, 2017
• Start date: December 2015
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Researchers of the three collaborating universities implement a pilot observational study in "Gilgel Gibe Field Research Center", a health and demographic surveillance system run by the Jimma University, Ethiopia. In this setting, the investigators plan to study risk factors in young men for the development of common mental disorders and psychotic symptoms and the stability of distinct symptoms of mental disorders in the community. The investigators will explore in particular the impact of lifestyle on mental health in young men, including the traditional habit of chewing khat leaves, which contain amphetamine-like cathinone. Furthermore, the investigators want to demonstrate the reliability and validity of assessments performed by trained local interviewers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 865
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Male, Age 18 - 30, permanent residents in Gilgel Gibe

Exclusion Criteria:

• Prior existing severe mental health problems

Related Conditions & MeSH terms

• Common Mental Disorders (CMD)
• Mental Disorders
• Psychotic Disorders
• Psychotic Symptoms

Intervention

Other:
• no intervention
no intervention, observational study

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Konstanz	Jimma University, Ludwig-Maximilians - University of Munich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychotic symptoms	presence of self-reported psychotic symptoms during the month before interview	through study completion, within 2 months
Primary	symptoms of Common Mental Disorders	presence of self-reported CMD symptoms during the month before interview	through study completion, within 2 months
Secondary	amount of khat use	self-reported amount of khat standard units consumed last week	through study completion, within 2 months
Secondary	amount of alcohol use	self-reported amount of alcohol standard units consumed last week	through study completion, within 2 months