Clinical trial NCT04648371: Community-based Cognitive Remediation and tDCS to Enhance Seniors' Function and Mental Health
Official title: Community-based Cognitive Remediation and tDCS to Enhance Seniors' Function and Mental Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Disorder
Aging
Keywords: Cognitive Remediation
Transcranial Direct Current Stimulation
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: LOFT Community Services
First posted: 2020-12-01
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Cognition
timeFrame: Baseline, after 8-week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)
measure: Change in Falls Risk using PPA
timeFrame: Baseline, after 8-week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)
measure: Change in Falls Risk using FROP-Com
timeFrame: Baseline, after 8-week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)
measure: Change in Functional Performance
timeFrame: Baseline, after 8 week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)
measure: Long Term Care Homes Transition
timeFrame: Enrolment to study completion (24, 36, 48, 60 months follow-up period, depending on time of enrolment)
Secondary outcomes:
measure: Personal Support Workers Delivery of Intervention
timeFrame: Study completion at 60 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Angela Golas, MD
role: PRINCIPAL_INVESTIGATOR
References: