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

Recruiting in Palo Alto (17 mi)

Overseen byAngela Golas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Centre for Addiction and Mental Health

No Placebo Group

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.

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

Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.

Willingness to provide informed consent or assent as applicable.

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.

+5 more

Exclusion Criteria

Has significant cognitive impairment that, in the opinion of the PI, precludes benefit from CR and therefore study participation.

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

I have not had electroconvulsive therapy in the last 6 months.

+1 more

Participant Groups

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.

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.