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

Aging Clinical Trial

— CREAtE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04648371
• Other study ID #: 010/2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: May 22, 2026

Study information

• Verified date: February 2024
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Aging
• Mental Disorders
• Mental Health Disorder

Intervention

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.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	LOFT Community Services

Country where clinical trial is conducted

Canada, 

Outcome

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

External Links

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