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

• Sponsor: University of Konstanz (Other)
• Overall Status: Completed
• CT.gov ID: NCT02615652
• Collaborator: Jimma University (Other), Ludwig-Maximilians - University of Munich (Other)
• Enrollment: 865
• Actual Duration (Months): 7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Common Mental Disorders (CMD); Psychotic Symptoms	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 865 participants
• Observational Model: Ecologic or Community
• Time Perspective: Cross-Sectional
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Outcome Measures

Primary Outcome Measures

1. psychotic symptoms [through study completion, within 2 months]

   presence of self-reported psychotic symptoms during the month before interview

2. symptoms of Common Mental Disorders [through study completion, within 2 months]

   presence of self-reported CMD symptoms during the month before interview

Secondary Outcome Measures

1. amount of khat use [through study completion, within 2 months]

   self-reported amount of khat standard units consumed last week

2. amount of alcohol use [through study completion, within 2 months]

   self-reported amount of alcohol standard units consumed last week

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Prior existing severe mental health problems

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Konstanz
• Jimma University
• Ludwig-Maximilians - University of Munich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Odenwald, Researcher, Akademischer Rat, University of Konstanz
• ClinicalTrials.gov Identifier: NCT02615652
• Other Study ID Numbers: University of Konstanz
• First Posted: Nov 26, 2015
• Last Update Posted: May 11, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Mental Disorders

Study Results

No Results Posted as of May 11, 2017