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Cognitive Remediation + tDCS for Mental Health Disorders in Seniors (CREAtE Trial)

N/A

Waitlist Available

Led By Angela Golas, MD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after 8 week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)

Summary

This trial will assess the effects of an 8-week course of cognitive remediation (CR) training among seniors with mental health conditions, followed by monthly boosters, to see if it can improve their lives and help them live independently.

Who is the study for?

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.

What is being tested?

The study tests an 8-week daily cognitive remediation (CR) training with monthly boosters over up to five years. It also examines if brain stimulation using tDCS can enhance CR's effectiveness. Participants will be randomly assigned to active or sham (fake) tDCS groups.

What are the potential side effects?

Potential side effects of tDCS may include discomfort at the electrode site on the scalp, itching, tingling during application, headache or fatigue after treatment. Cognitive Remediation typically does not have physical side effects but could cause temporary mental fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have skin diseases, pacemakers, metal in my head, brain devices, or conditions like epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after 8 week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after 8 week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 8 week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Cognition

Change in Falls Risk using FROP-Com

Change in Falls Risk using PPA

+2 more

Secondary study objectives

Personal Support Workers Delivery of Intervention

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Cognitive Remediation and Active Transcranial Direct Current StimulationActive Control1 Intervention

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.

Group II: Cognitive Remediation and Sham Transcranial Direct Current StimulationPlacebo Group1 Intervention

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.

0 / 2Eligibility criteria met