Aging Clinical Trial
— CREAtEOfficial title:
Community-based Cognitive Remediation and tDCS to Enhance Seniors' Function and Mental Health
Verified date | February 2024 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Focusing on seniors with mental health conditions who are living in the community, this initiative proposes to assess the acute and long-term effects of an 8-week course of daily (5 days/week) cognitive remediation (CR) training among 270 participants living in five LOFT senior housing units. The acute course of CR will be followed by monthly one-week boosters until the end of this 5-year study, totaling approximately 24-60 months of follow-up. This trial will also be used as a platform to explore the ability to use transcranial direct current stimulation (tDCS) to optimize response to CR by participant randomization to active versus sham tDCS. Our ultimate goal is to improve the lives of seniors experiencing mental illness and shape a future where they can live independently.
Status | Active, not recruiting |
Enrollment | 18 |
Est. completion date | May 22, 2026 |
Est. primary completion date | January 22, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: 1. Age 50 years and above. The rationale of age cutoff of 50 is that this age is considered a typical geriatric age cutoff especially for people with severe mental illness 2. Any race or ethnicity 3. Any gender identity 4. Meets DSM-V criteria for any disorder 5. Clinically stable as operationalized by (1) having not been admitted to a psychiatric hospital within the 3 months prior to assessment, (2) having had no change in psychotropic medication dosage within the 4 weeks prior to assessment, and (3) ascertained to be clinically and medically stable by one the study psychiatrists. 6. Willingness and ability to speak English 7. Willingness to provide informed consent or assent as applicable. 8. Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice. Exclusion Criteria: 1. Meets diagnostic criteria for active substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine 2. Electroconvulsive Therapy (ECT) within 6 months of initial assessment 3. Has significant cognitive impairment that, in the opinion of the PI, precludes benefit from CR and therefore study participation. 4. Having any contraindication to tDCS including: the presence of a skin disease, the presence of a pacemaker, implanted brain medical devices, the presence of any metal in the head or suffering from any unstable medical condition or illness that could increase the risk of stimulation (ie. epilepsy) |
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health | LOFT Community Services |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Cognition | Measured by Change in the Montreal Cognitive Assessment (MoCA)(Score range 0-30, higher scores reflect better outcome) | Baseline, after 8-week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline) | |
Primary | Change in Falls Risk using PPA | Measured by Change in the Physiological Profile Assessment (PPA) (a single index score derived from discriminant function analysis involving weighted scores of independent risk factors relative to a normative database; range: "very low" - "marked" falls risk; high score reflects high falls risk) | Baseline, after 8-week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline) | |
Primary | Change in Falls Risk using FROP-Com | Measured by Change in the Falls Risk in Older People in the Community (FROP-Com)(Score range 0-60, with higher scores indicative of greater risk) | Baseline, after 8-week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline) | |
Primary | Change in Functional Performance | Measured by Change in Performance Assessment of Self-Care Skills (PASS). Scale is scored from 0-3, score of 0 indicating inability to complete task, score of 3 indicating ability to complete task independently with no assistance. | Baseline, after 8 week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline) | |
Primary | Long Term Care Homes Transition | Measured by Number of Participants who Transition to Long Term Care Homes | Enrolment to study completion (24, 36, 48, 60 months follow-up period, depending on time of enrolment) | |
Secondary | Personal Support Workers Delivery of Intervention | Number of Personal Support Workers who Completed Training and Able to Administer tDCS + CR Independently | Study completion at 60 months |
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