Improving Cognitive Recovery in Multiple Sclerosis (CIRCuiTS-MS)

King's College London

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Behavioral: CIRCuiTS-MS

Study type: Interventional

Funder types: Other

Identifiers

NCT06877273

348879

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Immediate Treatment Group

Experimental group

Description:

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).

Treatment:

Behavioral: CIRCuiTS-MS

Delayed Treatment Group

Experimental group

Description:

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).

Treatment:

Behavioral: CIRCuiTS-MS