Community-based Cognitive Remediation and tDCS to Enhance Seniors' Function and Mental Health (CREAtE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging; Mental Health Disorder
• Intervention / Treatment: Other: Cognitive Remediation and Transcranial Direct Current Stimulation

Detailed Description

This project requires the complete assessment and treatment of 270 older adult participants living in LOFT senior housing. We will recruit individuals, age 50 or older, who meet criteria for any DSM-V diagnosis, and are living at a LOFT residence.

Prior to enrolment into the study, participants will undergo baseline assessments consisting of clinical, neuropsychological (NP) and functional assessments. Once enrolled, each participant will be randomized to receive transcranial direct current stimulation tDCS (active or sham) concurrent with Cognitive Remediation (CR) for 8 weeks, 5 days per week, followed by 3-5 day of booster sessions on a monthly basis until the end of the study. Trained study staff Personal Support Workers will be administering CR and tDCS for the 8-week intervention phase and the monthly boosters.

Participants will undergo NP and functional assessments at the end of the 8-week induction period, and then on an annual basis until the end of the study.

Primary Aim 1:

To assess whether active-tDCS + CR will result in better cognition (1a), lower fall rates (1b), better function (1c), and less transitions to LTCHs from LOFT (1d) compared to sham-tDCS + CR.

Hypothesis 1a: Participants randomized to active-tDCS + CR will demonstrate better cognition by the end of the 24-60 month follow-up period compared to those randomized to sham-tDCS + CR.

Hypothesis 1b: Participants randomized to active-tDCS + CR will demonstrate lower falls rates by the end of the 24-60 month follow-up period compared to those randomized to sham-tDCS + CR.

Hypothesis 1c: Participants randomized to active-tDCS + CR will demonstrate better self function by the end of the 24-60 month follow-up period compared to those randomized to sham-tDCS + CR.

Hypothesis 1d: Participants randomized to active-tDCS + CR will demonstrate less transitions to Long Term Care Homes by the end of the 24-60 month follow-up period compared to those randomized to sham-tDCS + CR.

Secondary Aim 2:

To build the capacity of LOFT PSWs to deliver tDCS and CR independently and with good fidelity to the intervention model.

Hypothesis 2: At each LOFT location, local PSWs will be certified to deliver tDCS and CR independently by the end of the first year of implementation of the study at each site.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6J1H4
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive Remediation and Active Transcranial Direct Current Stimulation; Cognitive Remediation (CR) is a form of group psychosocial intervention that uses a hybrid approach of restorative and strategy based methods to improve areas of cognition (ie. attention, memory, processing speed and learning) through the use of computerized exercises. Transcranial Direct Current Stimulation (tDCS): tDCS will be administered for 30 min/day, at the beginning of each group session. tDCS montage will be frontal with anode placed over Fz and the cathode over Iz. The direct current will be of 2 mA (current density = 0.57 A/m2). CR + tDCS is administered in groups consisting of 2-10 participants and one or two therapists. The groups meet 5 times per week for two hours per session over eight weeks, for a total of 40 sessions in induction phase. Afterwards 3 to 5 sessions per week on monthly boosters.	Other: Cognitive Remediation and Transcranial Direct Current Stimulation; Cognitive Remediation (CR) is a well-established psychosocial group intervention that aims to improve neurocognitive abilities such as memory performance, executive functioning, processing speed, and attention. Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation method that can be safely administered to awake outpatients. It does not require general anesthesia or surgical implantation. It utilizes low intensity electrical current (e.g., 2 mA) either to increase cortical excitability with an anodal electrode or to suppress cortical excitability with a cathodal electrode.
Sham Comparator: Cognitive Remediation and Sham Transcranial Direct Current Stimulation; CR is identical to the one described under the Active Comparator Arm. However, sham tDCS will consist of active stimulation for only 1 min/day, at the beginning of each group session. tDCS montage and the frequency of the sessions and the boosters will be the same as for the Active Arm.	Other: Cognitive Remediation and Transcranial Direct Current Stimulation; Cognitive Remediation (CR) is a well-established psychosocial group intervention that aims to improve neurocognitive abilities such as memory performance, executive functioning, processing speed, and attention. Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation method that can be safely administered to awake outpatients. It does not require general anesthesia or surgical implantation. It utilizes low intensity electrical current (e.g., 2 mA) either to increase cortical excitability with an anodal electrode or to suppress cortical excitability with a cathodal electrode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Collaborators: LOFT Community Services
• Investigators: Principal Investigator: Angela Golas, MD, Centre for Addiction and Mental Health

Publications and helpful links

Helpful Links

• 1. Statistics-Canada. Age and Sex Highlight Tables, 2016 Census.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): January 22, 2026
• Study Completion (Estimated): May 22, 2026

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation; Cognitive Remediation
• Additional Relevant MeSH Terms: Mental Disorders; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation; Cognitive Remediation
• Other Study ID Numbers: 010/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No