- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02955719
CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia (CCI)
CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia: Depression, Anxiety, and Mild Cognitive Impairment
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6J 1H4
- Centre for Addiction and Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Enrolled Cases
Integrated Care Pathway with different treatment interventions Interventions include: Sertraline, Venlafaxine, CBT/Psychological therapy, Psychiatric consultation, lifestyle intervention resources |
Other Names:
Other Names:
|
NO_INTERVENTION: Enrolled Controls
No intervention: Treatment as usual (TAU) will be provided by the primary care practice staff
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From Baseline Screening to 24 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability and perceived utility of the ICP
Time Frame: Baseline to 24 month follow-up
|
Qualitative data will be gathered from primary care teams to determine the acceptability and perceived utility data from brief team meetings and focus groups.
|
Baseline to 24 month follow-up
|
Feasibility of the ICP
Time Frame: Baseline to 24 month follow-up
|
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.
|
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
|
Qualitative data about the adjustments made at each primary care practice to adopt the ICP will be gathered from brief meetings and focus groups.
|
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
|
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
|
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
|
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.
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
Calculate the 6 month period prior to the last study assessment for a given recruitment site.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tarek Rajji, MD, Center for Addiction and Mental Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mood Disorders
- Neurocognitive Disorders
- Cognition Disorders
- Depression
- Depressive Disorder
- Anxiety Disorders
- Dementia
- Cognitive Dysfunction
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Sertraline
- Venlafaxine Hydrochloride
Other Study ID Numbers
- 019/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Sertraline
-
Beijing HuiLongGuan HospitalCompleted
-
Maastricht University Medical CenterPfizerCompletedDepression | Chest Pain | Panic AttacksNetherlands
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
University of Sao PauloCompletedObsessive-Compulsive DisorderBrazil
-
Washington University School of MedicineNational Heart, Lung, and Blood Institute (NHLBI)CompletedDepression | Myocardial Infarction | Heart Diseases | Cardiovascular Diseases | Angina, UnstableUnited States
-
TakedaCompletedCrohn's Disease | Ulcerative ColitisBelgium, United States, Korea, Republic of, Malaysia, Canada, Israel, Australia, Hungary, Czechia, Germany
-
University of PittsburghCompleted
-
Su RuiUnknown
-
Rhode Island HospitalStanford University; University of Cincinnati; American Epilepsy Society; Epilepsy...CompletedDepression | Stress Disorders, Post-Traumatic | Dissociative Disorders | Conversion Disorder | Convulsion, Non-EpilepticUnited States
-
TakedaCompleted