CIRCuiTS MS: Improving Cognitive Recovery in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
This study aims to find out whether an adapted version of an existing cognitive rehabilitation program, CIRCuiTS (https://www.circuitstherapyinfo.com), can be used to improve everyday thinking skills for people with Multiple Sclerosis (MS). People living with MS have worked with the study's researchers to adapt CIRCuiTS to meet their needs. They shared the thinking challenges they experience and suggested changes to the program's content and how it is delivered. This study will test whether this adapted version can be delivered practically to people with MS in a trial setting and explore its potential benefits. The findings will help plan a larger trial testing how effective CIRCuiTS is in helping people with MS.
Twenty-four people with MS will take part in this pilot trial. Each person will be randomly assigned to start the program either right away or after a 13-week wait. The therapy program involves up to 36 hours of therapist-led and independent sessions over 12 weeks in which the participant builds thinking skills through developing personal strategies for carrying out digital versions of tasks they find challenging. The practicality of delivering the program to people with MS will be judged based on whether problems arise in the trial, such as not being able to recruit enough people or participants not liking it. To explore its potential benefits, the study will check for improvements in progress toward personal goals, thinking abilities, emotional well-being, chronic tiredness, and daily living skills after the therapy.
If delivering CIRCuiTS to people with MS is found to be both practical and acceptable to participants, the findings of this trial will be used to design a larger-scale trial of its effectiveness. Ultimately, the goal of this project is to improve the quality of life of people living with cognitive difficulties related to MS.
详细描述
Objectives
The primary goal of this study is to assess the practical aspects of the research to determine whether a larger, fully-scale trial will be viable and acceptable. A feasibility decision will be reached by judging whether a suite of "Go"/"No-Go" thresholds associated with the primary outcome measures have been passed. Additionally, acceptability will be explored through qualitative analysis of participant exit interviews.
The secondary goal is to explore the potential that a larger trial will show that the program helps people with MS in meaningful ways.
Specifically, the study will examine whether the cognitive remediation program:
- Helps participants meet their personal goals
- Improves participants' cognitive function (how they think and think about thinking)
- Improves participants' mood (specifically feelings of anxiety and depression, which are common in people with MS)
- Helps reduce the severe fatigue that many people with MS experience
- Affects participants' ability to carry out everyday activities, such as managing tasks at home, working, and engaging in social and leisure activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a confirmed diagnosis of Multiple Sclerosis (MS), as verified by a healthcare provider.
- •Participants should be in a relatively stable phase of their condition, not experiencing a severe relapse or acute health crisis at the time of the study.
- •Participants must have sufficient cognitive abilities to engage in therapy sessions, meaning they can follow instructions and perform the cognitive tasks required during the remediation program.
- •Participants must be able to effectively communicate in English, both verbally and in writing, to interact with therapists and complete assessments.
- •Participants must be adults aged 18 years or older.
- •Participants should have personal experience with cognitive challenges related to MS, such as problems with memory, attention, or problem-solving.
- •Participants must be willing and able to commit to attending all therapy sessions over the 12-week period, as well as attending assessments and completing any required homework or independent sessions.
- •Participants must provide informed consent, demonstrating that they understand the purpose of the therapy trial and are willing to engage in the course of cognitive remediation.
- •Participants must have access to a computer (laptop or desktop) for at least one hour per week during the treatment period (12 weeks).
排除标准
- •Individuals who are currently receiving cognitive remediation or a similar intervention.
- •Individuals with high levels of depression, indicated by a score greater than 9 on the Patient Health Questionnaire-9 (PHQ-9).
- •Individuals with active suicidal ideation, indicated by a score greater than 0 on question 9 of the PHQ-
- •Individuals with a diagnosis of a psychotic disorder or bipolar disorder.
- •Physical disabilities that severely limit the individual's ability to attend therapy sessions or engage with the cognitive tasks (whether in-person or online) may lead to exclusion if suitable adaptations cannot be made.
研究组 & 干预措施
Immediate Treatment Group
Participants will start the cognitive remediation program immediately after recruitment. Outcome measures will be taken before treatment (week 1), immediately after treatment (week 14), and at 14 weeks after end of treatment (week 27).
干预措施: CIRCuiTS-MS (Behavioral)
Delayed Treatment Group
Participants will start the cognitive remediation program after being on a waitlist for 13 weeks. Outcome measures will be taken when added to the waitlist (week 1), before treatment (week 14), and immediately after treatment (week 27).
干预措施: CIRCuiTS-MS (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: Until the end of the study, estimated 15 months
Percentage of planned sample size recruited
Ethnic enrolment diversity
时间窗: Until the end of the study, estimated 15 months
Percentage of sample belonging to the most common ethnicity
Gender enrolment diversity
时间窗: Until the end of the study, estimated 15 months
Difference in the percentages of recruited participants identifying as male and female
Completion rate
时间窗: Until the end of the study, estimated 15 months
Percentage of participants completing week 27 measures
Dropout
时间窗: Until the end of the study, estimated 15 months
Percentage of enrolled participants who drop out
Serious adverse events
时间窗: Until the end of the study, estimated 15 months
Number of serious adverse events reported
Specific measure completeness
时间窗: Until the end of the study, estimated 15 months
Percentage outcome data complete per measure
Operational feasibility
时间窗: Until the end of the study, estimated 15 months
Number of significant operational issues that cannot be resolved
Midpoint retention
时间窗: Until the end of the study, estimated 15 months
Percentage of participants completing week 14 measures
Manageability of adverse events
时间窗: Until the end of the study, estimated 15 months
Number of adverse events that cause the study to be halted
Data completeness
时间窗: Until the end of the study, estimated 15 months
Percentage outcome data complete
Adherence: Therapy
时间窗: Until the end of the study, estimated 15 months
Percentage participants attending ≥ 70% of therapy sessions
Adherence: Independent sessions
时间窗: Until the end of the study, estimated 15 months
Percentage participants attending ≥ 40% of therapy sessions
Specific measure acceptability
时间窗: Until the end of the study, estimated 15 months
Percentage of participants who provide answers to demographic/medical background questions
Program acceptability
时间窗: Until the end of the study, estimated 15 months
Mean score on the general acceptability item of the Theoretical Framework of Acceptability Questionnaire
次要结局
- Goal Attainment Scale(From goal setting in week 1 to week 27)
- Measure of Insight into Cognition(From baseline assessment at week 1 to week 27)
- Brief International Cognitive Assessment for Multiple Sclerosis(From baseline assessment at week 1 to week 27)
- Digit Span(From baseline assessment at week 1 to week 27)
- Controlled Oral Word Association Test(From baseline assessment at week 1 to week 27)
- Patient Health Questionnaire-9(From baseline assessment at week 1 to week 27)
- Generalised Anxiety Disorder Scale(From baseline assessment at week 1 to week 27)
- Fatigue Severity Scale(From baseline assessment at week 1 to week 27)
- Work and Social Adjustment Scale(From baseline assessment at week 1 to week 27)