Community-based Cognitive Remediation and tDCS to Enhance Seniors' Function and Mental Health (NCT04648371) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Community-based Cognitive Remediation and tDCS to Enhance Seniors' Function and Mental Health
Canada18 participantsStarted 2021-01-27
Plain-language summary
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.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. 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
✓. Any race or ethnicity
✓. Any gender identity
✓. Meets DSM-V criteria for any disorder
✓. 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.
✓. Willingness and ability to speak English
✓. Willingness to provide informed consent or assent as applicable.
✓. 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
What they're measuring
1
Change in Cognition
Timeframe: Baseline, after 8-week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)
2
Change in Falls Risk using PPA
Timeframe: Baseline, after 8-week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)
3
Change in Falls Risk using FROP-Com
Timeframe: Baseline, after 8-week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)
4
Change in Functional Performance
Timeframe: Baseline, after 8 week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)
5
Long Term Care Homes Transition
Timeframe: Enrolment to study completion (24, 36, 48, 60 months follow-up period, depending on time of enrolment)
. Meets diagnostic criteria for active substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine
✕. Electroconvulsive Therapy (ECT) within 6 months of initial assessment
✕. Has significant cognitive impairment that, in the opinion of the PI, precludes benefit from CR and therefore study participation.
✕. 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)