AIDSNCT00339391
Socioenvironmental Determinants of Psychological Functioning, Mental Health and AIDS in Mali
An observational study of AIDS and Stress, run by National Institute of Mental Health (NIMH) at 1 site in Mali.
Trial summary
This project is a collaboration between the Centre Regional de Medecine Traditionnelle (CRMT) of the Malian National Institute of Public Health Research (INRSP) and the Section on Socioenvironmental Studies (SSES). These units developed a three-pronged protocol reflecting their joint and individual concerns: 1. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- How many people
- 1,002 participants
- Where
- 1 siteMali
- Study dates
- 19 Aug 2001to 30 Nov 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The study sample is a representative sample, based on Malian census data, of approximately 1000 respondents, age 16-50, drawn equally from each of the three generally pre-literate ethnic groups - the Dogon, the Peulh and the Bozo.
Who cannot join
- Villages must not have heavily visited tourist attractions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Socio-Environmental Determinants of Psychological Functioning, Mental Health and AIDS in Mali
This project is a collaboration between the Centre Regional de Medecine Traditionnelle (CRMT) of the Malian National Institute of Public Health Research (INRSP) and the Section on Socioenvironmental Studies (SSES). These units developed a three-pronged protocol reflecting their joint and individual concerns:
- Effects of occupational complexity on psychological functioning. The project tests a theory derived from previous SSES research demonstrating that in industrialized societies doing relatively self-directed, substantively complex work increases self-directed orientations to self, society and family and promotes effective intellectual functioning. It uses sociological survey methodology to determine the generalizability of this theory to an essentially pre-literate, preindustrial society.
- Effects of work-related stress on mental health. Earlier SSES work demonstrated that stressful work conditions lead to distress in industrialized societies. This project extends the investigation of these effects to a non-industrialized setting. It also extends the investigation of work-related stress to include work-related migration, resting a hypothesis that relates equally to SSES and CRMT concerns: that individuals from rural ethnic groups with a cultural tradition of work-related migration will show fewer mental health problems when migrating for nontraditional work than those from cultures without such a tradition. Mental health problems are assessed through: a) adaptations of standard survey-based psychological measures of components of distress, b) general and culture-specific survey-based psychiatric screening questions, and c) a psychiatric interview conducted by a CRMT psychiatrist trained in internationally accepted diagnostic procedures and knowledgeable about local cultures.
- The effects of migration and cultural and socioeconomic factors on AIDS-related knowledge, attitudes and behaviors. The survey addresses concern regarding the degree of knowledge about the nature of AIDS among rural Malians who are relatively isolated from urban oriented sources of information about culturally non-traditional issues. It also examines how socio-cultural background and migration for work affect AIDS related attitudes and self-reported behaviors in an African society where estimates of HIV prevalence are still relatively low (less than 2%), compared to those of other sub-Saharan African countries.
Although these prongs are distinguishable, each requires a longitudinal design, a representative sample, extensive information about responders' social and cultural backgrounds, occupational histories, work conditions, and personal orientations and beliefs. Because of their overlapping theoretical approaches and methodological requirements, combining them in one project increases the richness and efficiency of the data collected for each.
Read the detailed description
This project is a collaboration between the Centre Regional de Medecine Traditionnelle (CRMT) of the Malian National Institute of Public Health Research (INRSP) and the Section on Socioenvironmental Studies (SSES). These units developed a three-pronged protocol reflecting their joint and individual concerns:
- Effects of occupational complexity on psychological functioning. The project tests a theory derived from previous SSES research demonstrating that in industrialized societies doing relatively self-directed, substantively complex work increases self-directed orientations to self, society and family and promotes effective intellectual functioning. It uses sociological survey methodology to determine the generalizability of this theory to an essentially pre-literate, preindustrial society.
- Effects of work-related stress on mental health. Earlier SSES work demonstrated that stressful work conditions lead to distress in industrialized societies. This project extends the investigation of these effects to a non-industrialized setting. It also extends the investigation of work-related stress to include work-related migration, testing a hypothesis that relates equally to SSES and CRMT concerns: that individuals from rural ethnic groups with a cultural tradition of work-related migration will show fewer mental health problems when migrating for nontraditional work than those from cultures without such a tradition. Mental health problems are assessed through: a) adaptations of standard survey-based psychological measures of components of distress, b) general and culture-specific survey-based psychiatric screening questions, and c) a psychiatric interview conducted by a CRMT psychiatrist trained in internationally accepted diagnostic procedures and knowledgeable about local cultures.
- The effects of migration and cultural and socioeconomic factors on AIDS-related knowledge, attitudes and behaviors. The survey addresses concern regarding the degree of knowledge about the nature of AIDS among rural Malians who are relatively isolated from urban oriented sources of information about culturally non-traditional issues. It also examines how socio-cultural background and migration for work affect AIDS related attitudes and self-reported behaviors in an African society where estimates of HIV prevalence are still relatively low (less than 2%), compared to those of other sub-Saharan African countries.
Although these prongs are distinguishable, each requires a longitudinal design, a representative sample, extensive information about responders' social and cultural backgrounds, occupational histories, work conditions, and personal orientations and beliefs. Because of their overlapping theoretical approaches and methodological requirements, combining them in one project increases the richness and efficiency of the data collected for each.
The division of responsibility between SSES and CRMT is as follows:
- The survey questionnaire is the product of SSES/CRMT collaboration. It has been check by Malian linguists, extensively pretested by CRMT, and found feasible to administer and likely to provide highly reliable data with sufficient variance to permit the testing of our hypotheses. The project has been independently review and approved by the relevant Malian IRB the Ethics Committee and the Medical School of the University of Mali.
- Data Collection involves conducting structured sociological interviews with representative rural samples from three Malian ethnic groups, carrying out psychiatric interviews with respondents who fail the psychiatric screen. The collection, processing and coding of the data is the responsibility of CRMT.
- Data Analysis is primarily the responsibility of the SSES, which receives the data in a form in which individual respondents cannot be identified.
- Keywords
- Adjustment, Environmental Complexity, Mental Illness, Non-literate, West Africa, Stress, Knowledge, Mental Health, AIDS
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Mental Disorders, Psychological Well-Being
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start19 Aug 2001
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AIDSStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kathleen Merikangas, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339391
- Sponsor's protocol ID
- 999901244
- Other IDs
- 01-M-N244
- Status last verified
- 30 Nov 2016
- First submitted
- 19 Jun 2006
- Last updated
- 5 Dec 2019
- Results posted
- No
Publications
Kessler RC, Zhao S, Blazer DG, Swartz M. Prevalence, correlates, and course of minor depression and major depression in the National Comorbidity Survey. J Affect Disord. 1997 Aug;45(1-2):19-30. doi: 10.1016/s0165-0327(97)00056-6.
PubMed 9268772Maiga MY, Diarra B, Guindo A, Maiga YI, Fofano O, Bougoudogo F. [Seroprevalence of human immunodeficiency virus infection (HIV) in Mali on 3,496 sera]. Bull Soc Pathol Exot. 1993;86(1):16-20. French.
PubMed 8504258
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socio-Environmental Determinants of Psychological Functioning, Mental Health and AIDS in Mali
- ClinicalTrials.gov ID
- NCT00339391
- Acronym / sponsor ID
- 999901244
- Keywords
- Adjustment, Environmental Complexity, Mental Illness, Non-literate, West Africa, Stress, Knowledge, Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 19 Aug 2001
- Study completion
- 30 Nov 2016
- First posted
- 21 Jun 2006 (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.
This project is a collaboration between the Centre Regional de Medecine Traditionnelle (CRMT) of the Malian National Institute of Public Health Research (INRSP) and the Section on Socioenvironmental Studies (SSES). These units developed a three-pronged protocol reflecting their joint and individual concerns:
- Effects of occupational complexity on psychological functioning. The project tests a theory derived from previous SSES research demonstrating that in industrialized societies doing relatively self-directed, substantively complex work increases self-directed orientations to self, society and family and promotes effective intellectual functioning. It uses sociological survey methodology to determine the generalizability of this theory to an essentially pre-literate, preindustrial society.
- Effects of work-related stress on mental health. Earlier SSES work demonstrated that stressful work conditions lead to distress in industrialized societies. This project extends the investigation of these effects to a non-industrialized setting. It also extends the investigation of work-related stress to include work-related migration, resting a hypothesis that relates equally to SSES and CRMT concerns: that individuals from rural ethnic groups with a cultural tradition of work-related migration will show fewer mental health problems when migrating for nontraditional work than those from cultures without such a tradition. Mental health problems are assessed through: a) adaptations of standard survey-based psychological measures of components of distress, b) general and culture-specific survey-based psychiatric screening questions, and c) a psychiatric interview conducted by a CRMT psychiatrist trained in internationally accepted diagnostic procedures and knowledgeable about local cultures.
- The effects of migration and cultural and socioeconomic factors on AIDS-related knowledge, attitudes and behaviors. The survey addresses concern regarding the degree of knowledge about the nature of AIDS among rural Malians who are relatively isolated from urban oriented sources of information about culturally non-traditional issues. It also examines how socio-cultural background and migration for work affect AIDS related attitudes and self-reported behaviors in an African society where estimates of HIV prevalence are still relatively low (less than 2%), compared to those of other sub-Saharan African countries.
Although these prongs are distinguishable, each requires a longitudinal design, a representative sample, extensive information about responders' social and cultural backgrounds, occupational histories, work conditions, and personal orientations and beliefs. Because of their overlapping theoretical approaches and methodological requirements, combining them in one project increases the richness and efficiency of the data collected for each.
Detailed description
This project is a collaboration between the Centre Regional de Medecine Traditionnelle (CRMT) of the Malian National Institute of Public Health Research (INRSP) and the Section on Socioenvironmental Studies (SSES). These units developed a three-pronged protocol reflecting their joint and individual concerns:
- Effects of occupational complexity on psychological functioning. The project tests a theory derived from previous SSES research demonstrating that in industrialized societies doing relatively self-directed, substantively complex work increases self-directed orientations to self, society and family and promotes effective intellectual functioning. It uses sociological survey methodology to determine the generalizability of this theory to an essentially pre-literate, preindustrial society.
- Effects of work-related stress on mental health. Earlier SSES work demonstrated that stressful work conditions lead to distress in industrialized societies. This project extends the investigation of these effects to a non-industrialized setting. It also extends the investigation of work-related stress to include work-related migration, testing a hypothesis that relates equally to SSES and CRMT concerns: that individuals from rural ethnic groups with a cultural tradition of work-related migration will show fewer mental health problems when migrating for nontraditional work than those from cultures without such a tradition. Mental health problems are assessed through: a) adaptations of standard survey-based psychological measures of components of distress, b) general and culture-specific survey-based psychiatric screening questions, and c) a psychiatric interview conducted by a CRMT psychiatrist trained in internationally accepted diagnostic procedures and knowledgeable about local cultures.
- The effects of migration and cultural and socioeconomic factors on AIDS-related knowledge, attitudes and behaviors. The survey addresses concern regarding the degree of knowledge about the nature of AIDS among rural Malians who are relatively isolated from urban oriented sources of information about culturally non-traditional issues. It also examines how socio-cultural background and migration for work affect AIDS related attitudes and self-reported behaviors in an African society where estimates of HIV prevalence are still relatively low (less than 2%), compared to those of other sub-Saharan African countries.
Although these prongs are distinguishable, each requires a longitudinal design, a representative sample, extensive information about responders' social and cultural backgrounds, occupational histories, work conditions, and personal orientations and beliefs. Because of their overlapping theoretical approaches and methodological requirements, combining them in one project increases the richness and efficiency of the data collected for each.
The division of responsibility between SSES and CRMT is as follows:
- The survey questionnaire is the product of SSES/CRMT collaboration. It has been check by Malian linguists, extensively pretested by CRMT, and found feasible to administer and likely to provide highly reliable data with sufficient variance to permit the testing of our hypotheses. The project has been independently review and approved by the relevant Malian IRB the Ethics Committee and the Medical School of the University of Mali.
- Data Collection involves conducting structured sociological interviews with representative rural samples from three Malian ethnic groups, carrying out psychiatric interviews with respondents who fail the psychiatric screen. The collection, processing and coding of the data is the responsibility of CRMT.
- Data Analysis is primarily the responsibility of the SSES, which receives the data in a form in which individual respondents cannot be identified.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The study sample is a representative sample, based on Malian census data, of approximately 1000 respondents, age 16-50, drawn equally from each of the three generally pre-literate ethnic groups - the Dogon, the Peulh and the Bozo.
Key exclusion criteria (1 listed)
- Villages must not have heavily visited tourist attractions.
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
Not reported in the source record.
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 5 Dec 2019.
- Background: PubMed 9268772Kessler RC, Zhao S, Blazer DG, Swartz M. Prevalence, correlates, and course of minor depression and major depression in the National Comorbidity Survey. J Affect Disord. 1997 Aug;45(1-2):19-30. doi: 10.1016/s0165-0327(97)00056-6.
- Background: PubMed 8504258Maiga MY, Diarra B, Guindo A, Maiga YI, Fofano O, Bougoudogo F. [Seroprevalence of human immunodeficiency virus infection (HIV) in Mali on 3,496 sera]. Bull Soc Pathol Exot. 1993;86(1):16-20. French.
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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.
Kathleen Merikangas, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
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 AIDS and Stress, run by National Institute of Mental Health (NIMH) at 1 site in Mali.
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 5 Dec 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 Mali. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339391, which also lists 2 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 5 Dec 2019.