Cognitive Remediation + tDCS for Mental Health Disorders in Seniors
(CREAtE Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you must be clinically stable, which includes not having any changes in your psychotropic medication dosage within the 4 weeks before assessment.
What data supports the effectiveness of the treatment Cognitive Remediation and Transcranial Direct Current Stimulation for mental health disorders in seniors?
Research shows that transcranial direct current stimulation (tDCS) can improve cognitive functions like processing speed, working memory, and executive functions in people with mood and schizophrenia-spectrum disorders. It also suggests potential benefits for mental flexibility and inhibition in older adults with depression or anxiety.12345
Is Cognitive Remediation + tDCS safe for seniors with mental health disorders?
Transcranial Direct Current Stimulation (tDCS) has been used safely in many human trials, including with seniors and those with mental health disorders, without serious side effects. Common mild side effects include skin redness, tingling, and itching, which are usually temporary and well-tolerated.13678
How does the treatment Cognitive Remediation + tDCS for Mental Health Disorders in Seniors differ from other treatments?
This treatment is unique because it combines cognitive remediation (a therapy to improve thinking skills) with transcranial direct current stimulation (tDCS), a non-invasive method that uses a low electrical current to enhance brain function. Unlike traditional treatments, this approach specifically targets cognitive deficits in seniors with mental health disorders by potentially improving processing speed, working memory, and executive functions.12345
Research Team
Angela Golas, MD
Principal Investigator
Centre for Addiction and Mental Health
Eligibility Criteria
This trial is for seniors aged 50+ with mental health conditions who are stable, haven't been hospitalized for psychiatric reasons in the last 3 months, and haven't changed their psychotropic meds in the last month. They must be able to see, hear well enough to participate, speak English, and give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo clinical, neuropsychological, and functional assessments before enrollment
Treatment
Participants receive Cognitive Remediation (CR) and tDCS for 8 weeks, 5 days per week
Booster Sessions
Monthly booster sessions of CR and tDCS for 3-5 days each month
Follow-up
Participants are monitored for safety and effectiveness after treatment, with annual assessments
Treatment Details
Interventions
- Cognitive Remediation and Transcranial Direct Current Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre for Addiction and Mental Health
Lead Sponsor
LOFT Community Services
Collaborator
LOFT Community Services
Collaborator