Major Depressive DisorderPhase 1NCT00433238
Screening for Mental Health Concerns for at-Risk Community Living Chinese Seniors
A Phase 1 study testing Participants will be screened for depression and cognitive impairment, then receive screening results. in people with Major Depressive Disorder and Dementia, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
The study is designed to answer the following research questions: 1. Evaluate the acceptability of mental health screening and of the instruments used in a sample of community living Chinese seniors; 2. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Dementia
- What is being tested?
- Participants will be screened for depression and cognitive impairment, then receive screening results.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to not given
- Phase
- Phase 1
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- capable of providing informed consent
- informed consent
Who cannot join
- Individuals who are unable to fully understand the nature of the study, its possible risks and benefits and the consequences of providing or withholding consent, and who are, therefore, not capable of providing informed consent will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Mental Health Concerns for at-Risk Community Living Chinese Seniors - a Feasibility Study
The study is designed to answer the following research questions:
- Evaluate the acceptability of mental health screening and of the instruments used in a sample of community living Chinese seniors;
- Determine rates of mental health service utilization in individuals identified at screening as having psychological disturbance;
- Determine if identifying mental illness and informing participants of screening results and with treatment alternatives alters help-seeking pathways.
Read more
The study hypotheses are:
- This community sample of Chinese seniors will show a higher prevalence of psychological disturbance than their counterparts in the general population;
- Emotional well-being will be positively correlated with individuals' physical health and social support network.
Read the detailed description
A convenience sample will be drawn from 6 Congregate Dining (CD) groups in the Chinese community. There are six groups of CD programs run by Yee Hong Centre for Geriatric Care run at different locations in the Greater Toronto Area. The screening will be offered on site at regular CD meetings to participants who have given informed, written consent. All participants will attend a private post-screening interview. Those who score above the threshold for depression and/or cognitive impairment, and who have not previously been diagnosed or treated for these conditions, will be randomly assigned to one of two groups: an intervention group and a usual care group. Participants in the intervention group will receive their screening results at the post-screening interviews and will also be provided with suggestions for possible follow-up. They will be given the option of receiving further psychiatric assessment at the Wellness Centre, or seeking care with their family physician and assisted to obtain further care, if desired. Participants in the intervention group will attend an appointment 3 months after receiving screening results and follow-up options during which the rate of help seeking, rate of confirmed psychiatric diagnoses and types of intervention received will be determined. Participants in the usual care group will not be given screening results at the post-screening interview but will instead attend an appointment 3 months post screening to receive their results and information about follow-up options.
The results of this research will: demonstrate whether community living Chinese elders are at greater risk of psychiatric disorders and demonstrate the need for screening in older Chinese adults living in the community; aid in the development of systematic and targeted community-based screening and outreach to at-risk members of the target population; and help determine if identification of mental health issues and education about treatment resources has any effect on help-seeking for those conditions.
- Conditions
- Major Depressive Disorder, Dementia
- Being tested
- Participants will be screened for depression and cognitive impairment, then receive screening results.
- Keywords
- elderly, Chinese, community living, measurement, depression, dementia, Geriatric Depression Scale, MiniCog
- Medical subject headings
- Depressive Disorder, Major, Dementia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will be screened for depression and cognitive impairment, then receive screening results.Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of help seeking in intervention group
Rate of confirmed psychiatric diagnoses in intervention group
Type of intervention received
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2007 (estimated)
- Study startMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Investigators
- Joel Sadavoy, M.D., Principal investigator, Mt. Sinai Hospital, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433238
- Sponsor's protocol ID
- WCMSH
- Status last verified
- Feb 2007
- First submitted
- 7 Feb 2007
- Last updated
- 9 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Mental Health Concerns for at-Risk Community Living Chinese Seniors - a Feasibility Study
- ClinicalTrials.gov ID
- NCT00433238
- Acronym / sponsor ID
- WCMSH
- Conditions
- Major Depressive Disorder, Dementia
- Keywords
- elderly, Chinese, community living, measurement, depression, dementia, Geriatric Depression Scale, MiniCog
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Mar 2007
- First posted
- 9 Feb 2007 (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.
The study is designed to answer the following research questions:
- Evaluate the acceptability of mental health screening and of the instruments used in a sample of community living Chinese seniors;
- Determine rates of mental health service utilization in individuals identified at screening as having psychological disturbance;
- Determine if identifying mental illness and informing participants of screening results and with treatment alternatives alters help-seeking pathways.
The study hypotheses are:
- This community sample of Chinese seniors will show a higher prevalence of psychological disturbance than their counterparts in the general population;
- Emotional well-being will be positively correlated with individuals' physical health and social support network.
Detailed description
A convenience sample will be drawn from 6 Congregate Dining (CD) groups in the Chinese community. There are six groups of CD programs run by Yee Hong Centre for Geriatric Care run at different locations in the Greater Toronto Area. The screening will be offered on site at regular CD meetings to participants who have given informed, written consent. All participants will attend a private post-screening interview. Those who score above the threshold for depression and/or cognitive impairment, and who have not previously been diagnosed or treated for these conditions, will be randomly assigned to one of two groups: an intervention group and a usual care group. Participants in the intervention group will receive their screening results at the post-screening interviews and will also be provided with suggestions for possible follow-up. They will be given the option of receiving further psychiatric assessment at the Wellness Centre, or seeking care with their family physician and assisted to obtain further care, if desired. Participants in the intervention group will attend an appointment 3 months after receiving screening results and follow-up options during which the rate of help seeking, rate of confirmed psychiatric diagnoses and types of intervention received will be determined. Participants in the usual care group will not be given screening results at the post-screening interview but will instead attend an appointment 3 months post screening to receive their results and information about follow-up options.
The results of this research will: demonstrate whether community living Chinese elders are at greater risk of psychiatric disorders and demonstrate the need for screening in older Chinese adults living in the community; aid in the development of systematic and targeted community-based screening and outreach to at-risk members of the target population; and help determine if identification of mental health issues and education about treatment resources has any effect on help-seeking for those conditions.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- capable of providing informed consent
- informed consent
Key exclusion criteria (1 listed)
- Individuals who are unable to fully understand the nature of the study, its possible risks and benefits and the consequences of providing or withholding consent, and who are, therefore, not capable of providing informed consent will be excluded from the study.
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 |
|---|---|---|
| Participants will be screened for depression and cognitive impairment, then receive screening results. | Behavioural | – |
Primary outcome
Rate of help seeking in intervention group
Rate of confirmed psychiatric diagnoses in intervention group
Type of intervention received
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2007.
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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.
Joel Sadavoy, M.D. principal investigator
Mt. Sinai Hospital, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Participants will be screened for depression and cognitive impairment, then receive screening results. in people with Major Depressive Disorder and Dementia, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 2 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 9 Feb 2007. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 K.C. Chan (416-291-3883 ext. 225, kcchan@mtsinai.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of help seeking in intervention group. The study lists 3 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 9 Feb 2007.