Community-based Cognitive Remediation and tDCS to Enhance Seniors' Function and Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Falls Risk using FROP-Com
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Centrally administered, computer based generation scheme. Release of assignments only after consent and eligibility, and required baseline data collected. Inability to predict future assignments from past assignments. Creation of an audit trail for the assignment. Balanced Random Assignments to Treatment will be used to generate treatment assignment schedule in a random permuted block design. A file specifying the treatment allocation of each randomization ID will be stored with a member independent of the study. Then, the independent member will access the randomization ID and will access the treatment allocation and program tDCS. The randomization ID will be noted in the CRF but the allocation will not be accessed unless there is an SAE that requires breaking of the blind or the study is complete. In order to ensure that blinding has been maintained, participants and raters will be asked as each patient exits the trial to state what treatment they believe each participant was given.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Any race or ethnicity
- •Any gender identity
- •Meets DSM-V criteria for any disorder
- •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.
- •Willingness and ability to speak English
- •Willingness to provide informed consent or assent as applicable.
- •Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.
排除标准
- •Meets diagnostic criteria for active substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine
- •Electroconvulsive Therapy (ECT) within 6 months of initial assessment
- •Has significant cognitive impairment that, in the opinion of the PI, precludes benefit from CR and therefore study participation.
- •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)
研究组 & 干预措施
Cognitive Remediation and Active Transcranial Direct Current Stimulation
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.
干预措施: Cognitive Remediation and Transcranial Direct Current Stimulation (Other)
Cognitive Remediation and Sham Transcranial Direct Current Stimulation
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.
干预措施: Cognitive Remediation and Transcranial Direct Current Stimulation (Other)
结局指标
主要结局
Change in Falls Risk using FROP-Com
时间窗: 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)
Long Term Care Homes Transition
时间窗: 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
Change in Cognition
时间窗: 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)
Change in Functional Performance
时间窗: 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.
Change in Falls Risk using PPA
时间窗: 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)
次要结局
- Personal Support Workers Delivery of Intervention(Study completion at 60 months)
研究者
Angela Golas
Geriatric Psychiatrist
Centre for Addiction and Mental Health