Common Mental Disorders (CMD)NCT02615652
The Impact of Lifestyle on Mental Health Among Young Men in the Gilgel Gibe Field Research Center, Ethiopia: Pilot Study
An observational study of Common Mental Disorders (CMD) and Psychotic Symptoms, run by University of Konstanz.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Common Mental Disorders (CMD), Psychotic Symptoms
- How many people
- 865 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Young adult male inhabitants of the Gilgel Gibe field research center.
Who may be able to join
- Male, Age 18 - 30, permanent residents in Gilgel Gibe
Who cannot join
- Prior existing severe mental health problems
About this study
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.
- Conditions
- Common Mental Disorders (CMD), Psychotic Symptoms
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention, observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
psychotic symptoms
presence of self-reported psychotic symptoms during the month before interview
Measured: through study completion, within 2 months
symptoms of Common Mental Disorders
presence of self-reported CMD symptoms during the month before interview
Measured: through study completion, within 2 months
Secondary outcomes (2)
amount of khat use
self-reported amount of khat standard units consumed last week
Measured: through study completion, within 2 months
amount of alcohol use
self-reported amount of alcohol standard units consumed last week
Measured: through study completion, within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Mental Disorders (CMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 865 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- Jimma University, Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Michael Odenwald, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615652
- Sponsor's protocol ID
- University of Konstanz
- Status last verified
- May 2017
- First submitted
- 22 Nov 2015
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Lifestyle on Mental Health Among Young Men in the Gilgel Gibe Field Research Center, Ethiopia: Pilot Study
- ClinicalTrials.gov ID
- NCT02615652
- Acronym / sponsor ID
- University of Konstanz
- Conditions
- Common Mental Disorders (CMD), Psychotic Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 865 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- Jimma University, Ludwig-Maximilians - University of Munich
- Study start
- Dec 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young adult male inhabitants of the Gilgel Gibe field research center.
Key inclusion criteria (1 listed)
- Male, Age 18 - 30, permanent residents in Gilgel Gibe
Key exclusion criteria (1 listed)
- Prior existing severe mental health problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention, observational study | Other | – |
Primary outcome
psychotic symptoms
Time frame: through study completion, within 2 months
presence of self-reported psychotic symptoms during the month before interview
symptoms of Common Mental Disorders
Time frame: through study completion, within 2 months
presence of self-reported CMD symptoms during the month before interview
2 secondary outcomes
amount of khat use
Time frame: through study completion, within 2 months
amount of alcohol use
Time frame: through study completion, within 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Common Mental Disorders (CMD) and Psychotic Symptoms, run by University of Konstanz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychotic symptoms (time frame: through study completion, within 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.