Depressive SymptomsNCT03891836
Depressive Symptoms Among Medical Students
An observational study of Depressive Symptoms, run by Assiut University at 1 site in Egypt.
Trial summary
Depression is a common mental disorder, people with depression feel sadness anxious, loss of interest or pleasure, hopeless, helpless, worthless feelings of guilt and poor concentration. It can impair person's ability to function at work or school, or cope with daily life. It can lead to suicide. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Depressive Symptoms
- How many people
- 742 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 30 Jun 2020
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Study population: Egyptian students registered at faculty of Medicine, Assiut University in the academic year 2018-2019
Who may be able to join
- All Egyptian medical students at faculty of Medicine, Assiut University in the academic year 2018-2019
Who cannot join
- Non-Egyptian medical students
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Correlates of Depressive Symptoms Among Assiut University Medical Students
Depression is a common mental disorder, people with depression feel sadness anxious, loss of interest or pleasure, hopeless, helpless, worthless feelings of guilt and poor concentration. It can impair person's ability to function at work or school, or cope with daily life. It can lead to suicide.
Read the detailed description
Depressive symptoms are higher among women and its prevalence among university students was reported to be higher than the general population .There are various risk factors of depressive symptoms among university students, lower socioeconomic status, poor academic performance, overweight, life stressors, family history of psychiatric disorders, sleeping problems, and exposure to patients' suffering. Several studies were conducted among medical students in different Egyptian Universities to detect prevalence of depressive symptoms which were 42.9% in Al-Azhar Uni-versity, Cairo, 60.8% in Fayoum University, 59.2% in Mansoura University and 57.9% in Alexandria University.
A sense of control means having a feeling of autonomy, of choosing how you spend your time, of doing your own work in your own way, which is a key component of happiness. Depressive symptoms more common in those who feel there is little they can do to change important things in their lives.
Medical education is considered stressful. Medical students have psychological and academic stressors during their revolution from insecure students to young knowledgeable physicians, which were determined to be associated with depressive symptoms and decrease the quality of life and academic achievements.
- Conditions
- Depressive Symptoms
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| medical students | All students from the chosen classes in each study year will be invited to complete self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of depressive symptoms among medical students by patient health questionnaire-9
it is a scale used to diagnose major depressive disorder or other depressive disorder, each question in the scale take score from 0 to 3 summation of these scores detect degree of severity which is (1-4) minimal depression, (5-9) mild depression, (10-14) moderate depression, (15-19) moderately severe depression and (20-27) severe depression. It includes questions about: Lack of interest, depressed mood, sleeping difficulties, tiredness, appetite problems, negative feelings about self, concentration problems, psychomotor agitation/retardation and Suicidal ideation
Measured: one year
social class of the student by family affluence sale III (FAS-III)
FAS consists of 6 items. The responses to the items are given as specific values and calculated as an aggregated FAS index ranging from 0 to 13. The more index of FAS-III the higher is social class of the student. It consists of questions about: motor vehicle, bedroom, computers, bathrooms, dishwasher and holidays.
Measured: one year
Secondary outcomes (1)
sense of control by MIDI scale
A sense of control means having a feeling of autonomy, of choosing how you spend your time, of doing your own work in your own way, which is a key component of happiness. Depressive symptoms more common in those who feel there is little they can do to change important things in their lives. This scale is a self-report measure of sense of control of 12 items. It measures sense of control in 2 categories:
Perceived Constraints and Personal Mastery. The scores of 12 items will be averaged to create a composite measure. Higher scores indicated higher sense of control.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 742 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Medhat Soliman Gayed, Assiut University
- Investigators
- Sara Gayed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891836
- Sponsor's protocol ID
- Students' depressive symptoms
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hope V, Henderson M. Medical student depression, anxiety and distress outside North America: a systematic review. Med Educ. 2014 Oct;48(10):963-79. doi: 10.1111/medu.12512.
PubMed 25200017Coentre R, Faravelli C, Figueira ML. Assessment of depression and suicidal behaviour among medical students in Portugal. Int J Med Educ. 2016 Oct 29;7:354-363. doi: 10.5116/ijme.57f8.c468.
PubMed 27794561Ibrahim AK, Kelly SJ, Glazebrook C. Socioeconomic status and the risk of depression among U.K. higher education students. Soc Psychiatry Psychiatr Epidemiol. 2013 Sep;48(9):1491-501. doi: 10.1007/s00127-013-0663-5. Epub 2013 Feb 15.
PubMed 23412652Ngin C, Pal K, Tuot S, Chhoun P, Yi R, Yi S. Social and behavioural factors associated with depressive symptoms among university students in Cambodia: a cross-sectional study. BMJ Open. 2018 Sep 28;8(9):e019918. doi: 10.1136/bmjopen-2017-019918.
PubMed 30269060Reyes-Rodriguez ML, Rivera-Medina CL, Camara-Fuentes L, Suarez-Torres A, Bernal G. Depression symptoms and stressful life events among college students in Puerto Rico. J Affect Disord. 2013 Mar 5;145(3):324-30. doi: 10.1016/j.jad.2012.08.010. Epub 2012 Aug 29.
PubMed 22939390Angelone AM, Mattei A, Sbarbati M, Di Orio F. Prevalence and correlates for self-reported sleep problems among nursing students. J Prev Med Hyg. 2011 Dec;52(4):201-8.
PubMed 22442926Bovero A, Tosi C, Miniotti M, Torta R, Leombruni P. Medical Students Reflections Toward End-of-Life: a Hospice Experience. J Cancer Educ. 2018 Jun;33(3):634-639. doi: 10.1007/s13187-017-1171-1.
PubMed 28130710Shams-Eldin AA, Hassan H, Abo Elkhar O et al. (2017): Prevalence of Depression among Medical Students at Al-Azhar Uni¬versity, Cairo, Egypt; Community Med Public Health: CMPH-115. DOI: 10.29011/CMPH-115/100015.
Abdel Wahed W Y, Hassan S K. (2016): Prevalence and associated factors of stress, anxiety and depression among medical Fayoum University students; Alexandria Journal of Medicine Doi.org/10.1016/j.ajme.2016.01.005.
Barakat D, Elwasify M et al. (2016): Relation between insomnia and stress, anxiety, and depression among Egyptian medical students; Middle East Current Psychiatry, Volume 23, Number 3, July 2016, pp. 119-127(9), DOI: https://doi.org/10.1097/01.XME.0000484345.57567.a9.
Ibrahim MB, Abdelreheem MH. (2015): Prevalence of anxiety and depression among medical and pharmaceutical students in Alexandria/University Faculty of Medicine, Alexandria University. Alexandria J Med 2015;51:167-73.
Wardle J, Steptoe A, Gulis G, Sartory G, Sek H, Todorova I, Vogele C, Ziarko M. Depression, perceived control, and life satisfaction in university students from Central-Eastern and Western Europe. Int J Behav Med. 2004;11(1):27-36. doi: 10.1207/s15327558ijbm1101_4.
PubMed 15194517Alzahrani AHS. (2017): Depression and suicide among medical students: a comparison study between medical and medical sciences students in Taif University, Taif-KSA. W J Pmr., 3(2):1822.
Pillay N, Ramlall S, Burns JK. Spirituality, depression and quality of life in medical students in KwaZulu-Natal. S Afr J Psychiatr. 2016 Mar 22;22(1):731. doi: 10.4102/sajpsychiatry.v22i1.731. eCollection 2016.
PubMed 30263152
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Correlates of Depressive Symptoms Among Assiut University Medical Students
- ClinicalTrials.gov ID
- NCT03891836
- Acronym / sponsor ID
- Students' depressive symptoms
- Conditions
- Depressive Symptoms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 742 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 27 Mar 2019 (actual)
- 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.
Depression is a common mental disorder, people with depression feel sadness anxious, loss of interest or pleasure, hopeless, helpless, worthless feelings of guilt and poor concentration. It can impair person's ability to function at work or school, or cope with daily life. It can lead to suicide.
Detailed description
Depressive symptoms are higher among women and its prevalence among university students was reported to be higher than the general population .There are various risk factors of depressive symptoms among university students, lower socioeconomic status, poor academic performance, overweight, life stressors, family history of psychiatric disorders, sleeping problems, and exposure to patients' suffering. Several studies were conducted among medical students in different Egyptian Universities to detect prevalence of depressive symptoms which were 42.9% in Al-Azhar Uni-versity, Cairo, 60.8% in Fayoum University, 59.2% in Mansoura University and 57.9% in Alexandria University.
A sense of control means having a feeling of autonomy, of choosing how you spend your time, of doing your own work in your own way, which is a key component of happiness. Depressive symptoms more common in those who feel there is little they can do to change important things in their lives.
Medical education is considered stressful. Medical students have psychological and academic stressors during their revolution from insecure students to young knowledgeable physicians, which were determined to be associated with depressive symptoms and decrease the quality of life and academic achievements.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medical students | – | –All students from the chosen classes in each study year will be invited to complete self-administered questionnaire |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Egyptian students registered at faculty of Medicine, Assiut University in the academic year 2018-2019
Key inclusion criteria (1 listed)
- All Egyptian medical students at faculty of Medicine, Assiut University in the academic year 2018-2019
Key exclusion criteria (1 listed)
- Non-Egyptian medical students
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of depressive symptoms among medical students by patient health questionnaire-9
Time frame: one year
it is a scale used to diagnose major depressive disorder or other depressive disorder, each question in the scale take score from 0 to 3 summation of these scores detect degree of severity which is (1-4) minimal depression, (5-9) mild depression, (10-14) moderate depression, (15-19) moderately severe depression and (20-27) severe depression. It includes questions about: Lack of interest, depressed mood, sleeping difficulties, tiredness, appetite problems, negative feelings about self, concentration problems, psychomotor agitation/retardation and Suicidal ideation
social class of the student by family affluence sale III (FAS-III)
Time frame: one year
FAS consists of 6 items. The responses to the items are given as specific values and calculated as an aggregated FAS index ranging from 0 to 13. The more index of FAS-III the higher is social class of the student. It consists of questions about: motor vehicle, bedroom, computers, bathrooms, dishwasher and holidays.
1 secondary outcome
sense of control by MIDI scale
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Background: PubMed 25200017Hope V, Henderson M. Medical student depression, anxiety and distress outside North America: a systematic review. Med Educ. 2014 Oct;48(10):963-79. doi: 10.1111/medu.12512.
- Background: PubMed 27794561Coentre R, Faravelli C, Figueira ML. Assessment of depression and suicidal behaviour among medical students in Portugal. Int J Med Educ. 2016 Oct 29;7:354-363. doi: 10.5116/ijme.57f8.c468.
- Background: PubMed 23412652Ibrahim AK, Kelly SJ, Glazebrook C. Socioeconomic status and the risk of depression among U.K. higher education students. Soc Psychiatry Psychiatr Epidemiol. 2013 Sep;48(9):1491-501. doi: 10.1007/s00127-013-0663-5. Epub 2013 Feb 15.
- Background: PubMed 30269060Ngin C, Pal K, Tuot S, Chhoun P, Yi R, Yi S. Social and behavioural factors associated with depressive symptoms among university students in Cambodia: a cross-sectional study. BMJ Open. 2018 Sep 28;8(9):e019918. doi: 10.1136/bmjopen-2017-019918.
- Background: PubMed 22939390Reyes-Rodriguez ML, Rivera-Medina CL, Camara-Fuentes L, Suarez-Torres A, Bernal G. Depression symptoms and stressful life events among college students in Puerto Rico. J Affect Disord. 2013 Mar 5;145(3):324-30. doi: 10.1016/j.jad.2012.08.010. Epub 2012 Aug 29.
- Background: PubMed 22442926Angelone AM, Mattei A, Sbarbati M, Di Orio F. Prevalence and correlates for self-reported sleep problems among nursing students. J Prev Med Hyg. 2011 Dec;52(4):201-8.
- Background: PubMed 28130710Bovero A, Tosi C, Miniotti M, Torta R, Leombruni P. Medical Students Reflections Toward End-of-Life: a Hospice Experience. J Cancer Educ. 2018 Jun;33(3):634-639. doi: 10.1007/s13187-017-1171-1.
- BackgroundShams-Eldin AA, Hassan H, Abo Elkhar O et al. (2017): Prevalence of Depression among Medical Students at Al-Azhar Uni¬versity, Cairo, Egypt; Community Med Public Health: CMPH-115. DOI: 10.29011/CMPH-115/100015.
- BackgroundAbdel Wahed W Y, Hassan S K. (2016): Prevalence and associated factors of stress, anxiety and depression among medical Fayoum University students; Alexandria Journal of Medicine Doi.org/10.1016/j.ajme.2016.01.005.
- BackgroundBarakat D, Elwasify M et al. (2016): Relation between insomnia and stress, anxiety, and depression among Egyptian medical students; Middle East Current Psychiatry, Volume 23, Number 3, July 2016, pp. 119-127(9), DOI: https://doi.org/10.1097/01.XME.0000484345.57567.a9.
- BackgroundIbrahim MB, Abdelreheem MH. (2015): Prevalence of anxiety and depression among medical and pharmaceutical students in Alexandria/University Faculty of Medicine, Alexandria University. Alexandria J Med 2015;51:167-73.
- Background: PubMed 15194517Wardle J, Steptoe A, Gulis G, Sartory G, Sek H, Todorova I, Vogele C, Ziarko M. Depression, perceived control, and life satisfaction in university students from Central-Eastern and Western Europe. Int J Behav Med. 2004;11(1):27-36. doi: 10.1207/s15327558ijbm1101_4.
- Individual participant dataSharing planned: Undecided
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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.
Sara Gayed principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Symptoms, run by Assiut University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Randa Shams-Eldin, Professor (01066211997 ext. 002, Randashams@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of depressive symptoms among medical students by patient health questionnaire-9 (time frame: one year). 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?
On the ClinicalTrials.gov record for NCT03891836, which also lists 14 linked publications.
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 27 Mar 2019.