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

Aging Clinical Trial

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

Status Active, not recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Aging
• Mental Disorders
• Mental Health Disorder

• NCT number: NCT04648371
• Study type: Interventional
• Source: Centre for Addiction and Mental Health
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 27, 2021
• Completion date: May 22, 2026