Centre for Addiction and Mental Health
Toronto, Ontario, M6J1H4, Canada
NCT Number: NCT04648371
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.
This study is active but is not currently recruiting participants.
Notify Me50 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M6J1H4, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cognitive Remediation (CR) is a well-established psychosocial group intervention that aims to improve neurocognitive abilities such as memory performance, executive functioning, processing speed, and attention.
Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation method that can be safely administered to awake outpatients. It does not require general anesthesia or surgical implantation. It utilizes low intensity electrical current (e.g., 2 mA) either to increase cortical excitability with an anodal electrode or to suppress cortical excitability with a cathodal electrode.
Time frame: Baseline, after 8-week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)
Measured by Change in the Montreal Cognitive Assessment (MoCA)(Score range 0-30, higher scores reflect better outcome)
Time frame: Baseline, after 8-week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)
Measured by Change in the Physiological Profile Assessment (PPA) (a single index score derived from discriminant function analysis involving weighted scores of independent risk factors relative to a normative database; range: "very low" - "marked" falls risk; high score reflects high falls risk)
Time frame: Baseline, after 8-week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)
Measured by Change in the Falls Risk in Older People in the Community (FROP-Com)(Score range 0-60, with higher scores indicative of greater risk)
Time frame: Baseline, after 8 week induction phase, and annually until study completion (12, 24, 36, 48, 60 months after baseline)
Measured by Change in Performance Assessment of Self-Care Skills (PASS). Scale is scored from 0-3, score of 0 indicating inability to complete task, score of 3 indicating ability to complete task independently with no assistance.
Time frame: Enrolment to study completion (24, 36, 48, 60 months follow-up period, depending on time of enrolment)
Measured by Number of Participants who Transition to Long Term Care Homes
Time frame: Study completion at 60 months
Number of Personal Support Workers who Completed Training and Able to Administer tDCS + CR Independently
Centre for Addiction and Mental Health
Other
Acronym: CREAtE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06233747
Behavior, Behavioral Symptoms
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT06449521
Behavior, Disease Attributes
Kathmandu, Nepal
View Trial DetailsNCT06980233
Behavior, Chemically-Induced Disorders
Worcester, Massachusetts, United States
View Trial DetailsNCT05103033
Mental Disorders, Mental Health Disorder
Catandica, Manica Province, Mozambique
View Trial Details