DepressionCCINCT02955719
CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia
A study testing Sertraline, Venlafaxine and CBT/Psychological Therapy in people with Depression and Anxiety, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Age remains the single most significant risk factor for developing dementia, particularly Alzheimer's dementia (AD). Given the rate at which Canada's population is aging, the quest to determine modifiable risk factors, whether by prevention, earlier detection, or an ability to slow the rate of decline, is a key… Read more about this study
- Who is it for?
- Ages 60 to 65 years
- Conditions the study is for
- Depression, Anxiety, Mild Cognitive Impairment
- What is being tested?
- Sertraline, Venlafaxine and CBT/Psychological Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2016to 16 Jul 2020
- Phase
- Interventional
- 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 60 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male primary practice patients of participating physicians born in 1951, 1953 or 1955 (ICP) and 1950, 1952 or 1956 (TAU).
- Can read and understand English.
- Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.
- Willing and able to provide informed consent
Who cannot join
- Diagnosis of dementia.
- Substance abuse identified as an acute problem in the four weeks before being enrolled in the study (i.e. the day the patient signs the informed consent form).
- Those with delirium, or where we are unable to make a diagnosis of MCI, due to unstable comorbidities.
- Palliative-care patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia: Depression, Anxiety, and Mild Cognitive Impairment
Age remains the single most significant risk factor for developing dementia, particularly Alzheimer's dementia (AD). Given the rate at which Canada's population is aging, the quest to determine modifiable risk factors, whether by prevention, earlier detection, or an ability to slow the rate of decline, is a key priority in health care. Primary care is likely to play a pivotal role in this initiative. Collaborative mental health care between primary care providers and mental health clinicians has been demonstrated to be effective at the patient and system levels. Thus, the overall goal of this project is to assess impact and feasibility of implementing a collaborative care evidence-based Integrated Care Pathway (ICP) in addressing three potentially reversible risk factors at high risk for developing AD: anxiety, depression, or mild cognitive impairment (MCI).
Read the detailed description
The investigators will enroll 150 participants overall (CAMH and McMaster). Seventy-five will be cases who will be enrolled into the ICP arm of the study and these will be patients born in the calendar year 1951, 1953 or 1955. The investigators will enroll an additional 75 controls that were born in the calendar year 1950, 1952 or 1956.
Patients of general practitioners being seen at primary healthcare clinics in the Greater Toronto Area and in Hamilton, who were born in the calendar year 1950, 1951, 1952, 1953, 1955, or 1956 will be consented and screened for anxiety, depression, and Mild Cognitive Impairment (MCI).
If patients born in 1951, 1953 and 1955 reach a threshold level of anxiety, depression, or MCI symptom burden and have a confirmed diagnosis, rather than receive treatment as usual, the participants will be enrolled into an Integrated Care Pathway (ICP), which offers evidence-informed treatment for the management of these syndromes in a routine, algorithmic fashion. All enrolled cases entered in the study will be provided with general interventions that address lifestyle and medical factors that both contribute to these syndromes and are thought to predispose patients to develop dementia. If the symptom burden is severe enough, based on standardized assessments, evidence-based psychopharmacology (a trial of sertraline and/or venlafaxine) will also be offered, with a standardized titration schedule. Collaboration will be built into the ICP - a psychiatrist will be present at the clinic and in contact with primary care providers to provide patient- and physician-level support, consultation, and episodes of care as necessary. Rates of anxiety, depression, and MCI diagnosis/detection, time to treatment initiation, and improvement in symptom burden will be assessed.
If patients born in 1950, 1952 and 1956 reach a threshold level of anxiety, depression, or MCI symptom burden, these individuals will form our comparison group and will receive treatment as usual (TAU).
- Conditions
- Depression, Anxiety, Mild Cognitive Impairment
- Being tested
- Sertraline, Venlafaxine, CBT/Psychological Therapy, Psychiatric Consultation, Lifestyle Intervention Resources
- Keywords
- Collaborative Care, Depression, Anxiety, Mild Cognitive Impairment, Integrated Care Pathway
- Medical subject headings
- Depression, Anxiety Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called zoloft
VenlafaxineDrug
Also called effexor
CBT/Psychological TherapyOther
Psychiatric ConsultationOther
Lifestyle Intervention ResourcesOther
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Cases | Experimental | Integrated Care Pathway with different treatment interventions
Interventions include:
Sertraline, Venlafaxine, CBT/Psychological therapy, Psychiatric consultation, lifestyle intervention resources Receives: Drug: Sertraline; Drug: Venlafaxine; Other: CBT/Psychological Therapy; Other: Psychiatric Consultation; Other: Lifestyle Intervention Resources |
| Enrolled Controls | No intervention | No intervention: Treatment as usual (TAU) will be provided by the primary care practice staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety/depression/quality of life (QOL) scores among participants in the ICP and comparison groups
Comparison for the GAD-7/PHQ-9/QOL scores will be assessed using Group x Time ANOVAs repeated measure comparing scores at assessment times in the intervention and comparison groups.
Measured: From Baseline Screening to 24 month follow-up
Secondary outcomes (8)
Acceptability and perceived utility of the ICP
Qualitative data will be gathered from primary care teams to determine the acceptability and perceived utility data from brief team meetings and focus groups.
Measured: Baseline to 24 month follow-up
Feasibility of the ICP
Qualitative data for the feasibility indicators will be obtained from the information collected by the research coordinator from the primary care team during the recruitment, screening, and data collection phases of the study, as well as the chart review.
Measured: Baseline to 24 month follow-up
Adjustments made for the adoption of the ICP in primary care teams
Qualitative data about the adjustments made at each primary care practice to adopt the ICP will be gathered from brief meetings and focus groups.
Measured: Baseline to 24 month follow-up
Barriers to implementation of the ICP and the key elements to initiate, sustain and spread the ICP
Qualitative data on difficulties with implementing the ICP, as well as information on successfully initiating and supporting the ICP will be gathered from brief meetings and focus groups
Measured: Baseline to 24 month follow-up
Changes in the primary care providers' knowledge of, and ability to recognize and manage, depression, anxiety, and MCI in older adults.
Mean ratings on the Primary Care Team Questionnaire will be calculated at baseline and at the end of the study and compared using t-tests.
Measured: Baseline to 24 month follow-up
Time-to-treatment initiation among those in the ICP arm versus those in the comparison arm.
The length of time from identification of anxiety, depression or MCI and the start of the ICP intervention (i.e., time-to-treatment initiation) will be calculated in days for patients in the intervention group and comparison group. The average length of time-to-treatment initiation will be calculated for each group and these means will be compared using a t-test.
Measured: Baseline to 24 month followup
Specific Aim 3a: To assess the impact of the ICP on the rates of diagnoses/detection among older patients with anxiety, depression, or MCI compared to before ICP implementation.
During the recruitment phase of the study, charts of patients born in 1950, 1954 will be reviewed to identify diagnosis of depression, anxiety and/or MCI prior to the implementation of the ICP. The period of data collection for this chart review is calculated as one year prior to the time of the SIV for all sites.
Measured: Calculate one year prior to the time of Site Initiation Visit for all recruiting sites.
Specific Aim 3b: To assess the impact of ICP on rates of diagnoses/detection among patients of the same age cohort as our target ICP population, but not in our study sample.
We will review contamination effects by reviewing the charts of clinic patients born in 1954 and 1958 to identify the diagnosis/detection of depression, anxiety and/or MCI in the 6 month period prior to the last study assessment for a given recruitment site.
Measured: Calculate the 6 month period prior to the last study assessment for a given recruitment site.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start30 Mar 2016
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Tarek Rajji, Centre for Addiction and Mental Health
- Investigators
- Tarek Rajji, MD, Principal investigator, Center for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955719
- Sponsor's protocol ID
- 019/2016
- Acronym
- CCI
- Status last verified
- Jan 2021
- First submitted
- 24 Oct 2016
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kates N, Craven M; Collaborative Working Group of the College of Family Physicians of Canada, Canadian Psychiatric Association. Shared mental health care. Update from the Collaborative Working Group of the College of Family Physicians of Canada and the Canadian Psychiatric Association. Can Fam Physician. 2002 May;48:936. No abstract available.
PubMed 12053639
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia: Depression, Anxiety, and Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT02955719
- Acronym / sponsor ID
- CCI / 019/2016
- Conditions
- Depression, Anxiety, Mild Cognitive Impairment
- Keywords
- Collaborative Care, Depression, Anxiety, Mild Cognitive Impairment, Integrated Care Pathway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 4 Nov 2016 (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.
Age remains the single most significant risk factor for developing dementia, particularly Alzheimer's dementia (AD). Given the rate at which Canada's population is aging, the quest to determine modifiable risk factors, whether by prevention, earlier detection, or an ability to slow the rate of decline, is a key priority in health care. Primary care is likely to play a pivotal role in this initiative. Collaborative mental health care between primary care providers and mental health clinicians has been demonstrated to be effective at the patient and system levels. Thus, the overall goal of this project is to assess impact and feasibility of implementing a collaborative care evidence-based Integrated Care Pathway (ICP) in addressing three potentially reversible risk factors at high risk for developing AD: anxiety, depression, or mild cognitive impairment (MCI).
Detailed description
The investigators will enroll 150 participants overall (CAMH and McMaster). Seventy-five will be cases who will be enrolled into the ICP arm of the study and these will be patients born in the calendar year 1951, 1953 or 1955. The investigators will enroll an additional 75 controls that were born in the calendar year 1950, 1952 or 1956.
Patients of general practitioners being seen at primary healthcare clinics in the Greater Toronto Area and in Hamilton, who were born in the calendar year 1950, 1951, 1952, 1953, 1955, or 1956 will be consented and screened for anxiety, depression, and Mild Cognitive Impairment (MCI).
If patients born in 1951, 1953 and 1955 reach a threshold level of anxiety, depression, or MCI symptom burden and have a confirmed diagnosis, rather than receive treatment as usual, the participants will be enrolled into an Integrated Care Pathway (ICP), which offers evidence-informed treatment for the management of these syndromes in a routine, algorithmic fashion. All enrolled cases entered in the study will be provided with general interventions that address lifestyle and medical factors that both contribute to these syndromes and are thought to predispose patients to develop dementia. If the symptom burden is severe enough, based on standardized assessments, evidence-based psychopharmacology (a trial of sertraline and/or venlafaxine) will also be offered, with a standardized titration schedule. Collaboration will be built into the ICP - a psychiatrist will be present at the clinic and in contact with primary care providers to provide patient- and physician-level support, consultation, and episodes of care as necessary. Rates of anxiety, depression, and MCI diagnosis/detection, time to treatment initiation, and improvement in symptom burden will be assessed.
If patients born in 1950, 1952 and 1956 reach a threshold level of anxiety, depression, or MCI symptom burden, these individuals will form our comparison group and will receive treatment as usual (TAU).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enrolled Cases | Experimental | Drug: Sertraline, Drug: Venlafaxine, Other: CBT/Psychological Therapy, Other: Psychiatric Consultation, Other: Lifestyle Intervention ResourcesIntegrated Care Pathway with different treatment interventions Interventions include: Sertraline, Venlafaxine, CBT/Psychological therapy, Psychiatric consultation, lifestyle intervention resources |
| Enrolled Controls | No intervention | –No intervention: Treatment as usual (TAU) will be provided by the primary care practice staff |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female or male primary practice patients of participating physicians born in 1951, 1953 or 1955 (ICP) and 1950, 1952 or 1956 (TAU).
- Can read and understand English.
- Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.
- Willing and able to provide informed consent
Key exclusion criteria (4 listed)
- Diagnosis of dementia.
- Substance abuse identified as an acute problem in the four weeks before being enrolled in the study (i.e. the day the patient signs the informed consent form).
- Those with delirium, or where we are unable to make a diagnosis of MCI, due to unstable comorbidities.
- Palliative-care patients.
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 |
|---|---|---|
| SertralineAlso: zoloft | Drug | Enrolled Cases |
| VenlafaxineAlso: effexor | Drug | Enrolled Cases |
| CBT/Psychological Therapy | Other | Enrolled Cases |
| Psychiatric Consultation | Other | Enrolled Cases |
| Lifestyle Intervention Resources | Other | Enrolled Cases |
Primary outcome
Change in anxiety/depression/quality of life (QOL) scores among participants in the ICP and comparison groups
Time frame: From Baseline Screening to 24 month follow-up
Comparison for the GAD-7/PHQ-9/QOL scores will be assessed using Group x Time ANOVAs repeated measure comparing scores at assessment times in the intervention and comparison groups.
8 secondary outcomes
Acceptability and perceived utility of the ICP
Time frame: Baseline to 24 month follow-up
Feasibility of the ICP
Time frame: Baseline to 24 month follow-up
Adjustments made for the adoption of the ICP in primary care teams
Time frame: Baseline to 24 month follow-up
Barriers to implementation of the ICP and the key elements to initiate, sustain and spread the ICP
Time frame: Baseline to 24 month follow-up
Changes in the primary care providers' knowledge of, and ability to recognize and manage, depression, anxiety, and MCI in older adults.
Time frame: Baseline to 24 month follow-up
Time-to-treatment initiation among those in the ICP arm versus those in the comparison arm.
Time frame: Baseline to 24 month followup
Specific Aim 3a: To assess the impact of the ICP on the rates of diagnoses/detection among older patients with anxiety, depression, or MCI compared to before ICP implementation.
Time frame: Calculate one year prior to the time of Site Initiation Visit for all recruiting sites.
Specific Aim 3b: To assess the impact of ICP on rates of diagnoses/detection among patients of the same age cohort as our target ICP population, but not in our study sample.
Time frame: Calculate the 6 month period prior to the last study assessment for a given recruitment site.
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 7 Jan 2021.
- Results publication: PubMed 12053639Kates N, Craven M; Collaborative Working Group of the College of Family Physicians of Canada, Canadian Psychiatric Association. Shared mental health care. Update from the Collaborative Working Group of the College of Family Physicians of Canada and the Canadian Psychiatric Association. Can Fam Physician. 2002 May;48:936. No abstract available.
- : Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tarek Rajji, MD principal investigator
Center for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sertraline, Venlafaxine and CBT/Psychological Therapy in people with Depression and Anxiety, run by Centre for Addiction and Mental Health 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 4 inclusion and 4 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 7 Jan 2021. 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.
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?
Change in anxiety/depression/quality of life (QOL) scores among participants in the ICP and comparison groups (time frame: From Baseline Screening to 24 month follow-up). 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 NCT02955719, which also lists 1 linked publication.
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 7 Jan 2021.