Clinical trial NCT06877273: Improving Cognitive Recovery in Multiple Sclerosis
Official title: CIRCuiTS MS: Improving Cognitive Recovery in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Cognitive rehabilitation
cognitive training
cognitive remediation
thinking skills
randomised controlled trial
feasibility
acceptability
metacognition
cognitive remediation therapy
cognitive dysfunction
cognitive function
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
First posted: 2025-03-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to one of two groups:

1. Immediate Treatment Group: Participants will start the cognitive remediation program immediately.
2. Delayed Treatment Group: Participants will be placed on a waitlist and receive the program after 14 weeks
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. Helps participants meet their personal goals
2. Improves participants' cognitive function (how they think and think about thinking)
3. Improves participants' mood (specifically feelings of anxiety and depression, which are common in people with MS)
4. Helps reduce the severe fatigue that many people with MS experience
5. Affects participants' ability to carry out everyday activities, such as managing tasks at home, working, and engaging in social and leisure activities.

These factors will be evaluated through assessing change in the secondary outcome measures after therapy.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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-9.
* 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: Until the end of the study, estimated 15 months
measure: Ethnic enrolment diversity
timeFrame: Until the end of the study, estimated 15 months
measure: Gender enrolment diversity
timeFrame: Until the end of the study, estimated 15 months
measure: Completion rate
timeFrame: Until the end of the study, estimated 15 months
measure: Midpoint retention
timeFrame: Until the end of the study, estimated 15 months
measure: Dropout
timeFrame: Until the end of the study, estimated 15 months
measure: Serious adverse events
timeFrame: Until the end of the study, estimated 15 months
measure: Manageability of adverse events
timeFrame: Until the end of the study, estimated 15 months
measure: Data completeness
timeFrame: Until the end of the study, estimated 15 months
measure: Specific measure completeness
timeFrame: Until the end of the study, estimated 15 months
measure: Operational feasibility
timeFrame: Until the end of the study, estimated 15 months
measure: Adherence: Therapy
timeFrame: Until the end of the study, estimated 15 months
measure: Adherence: Independent sessions
timeFrame: Until the end of the study, estimated 15 months
measure: Specific measure acceptability
timeFrame: Until the end of the study, estimated 15 months
measure: Program acceptability
timeFrame: Until the end of the study, estimated 15 months
Secondary outcomes:
measure: Goal Attainment Scale
timeFrame: From goal setting in week 1 to week 27
measure: Measure of Insight into Cognition
timeFrame: From baseline assessment at week 1 to week 27
measure: Brief International Cognitive Assessment for Multiple Sclerosis
timeFrame: From baseline assessment at week 1 to week 27
measure: Digit Span
timeFrame: From baseline assessment at week 1 to week 27
measure: Controlled Oral Word Association Test
timeFrame: From baseline assessment at week 1 to week 27
measure: Patient Health Questionnaire-9
timeFrame: From baseline assessment at week 1 to week 27
measure: Generalised Anxiety Disorder Scale
timeFrame: From baseline assessment at week 1 to week 27
measure: Fatigue Severity Scale
timeFrame: From baseline assessment at week 1 to week 27
measure: Work and Social Adjustment Scale
timeFrame: From baseline assessment at week 1 to week 27
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
state: East of England
Study officials:
affiliation: King's College London
name: Sara Simblett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Til Wykes, PhD
role: PRINCIPAL_INVESTIGATOR
References: