A cluster-randomised controlled feasibility trial evaluating the Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS)

Sinéad M. Hynes; Christopher P. Dwyer; Alberto Alvarez-Iglesias; Fionnuala Rogers; Robert A. Joyce; Megan H. Oglesby; Anusha Moses; Eimear Bane; Timothy J. Counihan; Beatrice Charamba; COB-MS PPI Advisory Panel 1

doi:10.1007/s10072-024-07757-5

A cluster-randomised controlled feasibility trial evaluating the Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS)

Sinéad M. Hynes
, Christopher P. Dwyer
, Alberto Alvarez-Iglesias
, Fionnuala Rogers^*
, Robert A. Joyce
, Megan H. Oglesby
, Anusha Moses
, Eimear Bane
, Timothy J. Counihan
, Beatrice Charamba
, COB-MS PPI Advisory Panel 1

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

1 Citation (Scopus)

5 Downloads (Pure)

Abstract

Introduction: There is a high prevalence of cognitive difficulties in MS, but despite this, there are few programmes targeting cognition that focus on the ability to function well in everyday life. The Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS), an occupation-focused cognitive intervention, was developed to address this. It addresses both the functional difficulties and the wide-ranging symptoms that present in MS.

Objective: Here we report on the results of a cluster-randomised controlled feasibility trial (ISRCTN11462710; registered 4th September 2019) evaluating the COB-MS in terms of feasibility and initial efficacy as a cognitive intervention for people with MS.

Method: The eight-session COB-MS intervention was delivered remotely by occupational therapists to participants with MS in the intervention group. Following the end of the trial the COB-MS was delivered to the wait-list control group. Data was collected from people with MS experiencing cognitive difficulties at baseline, post-intervention, 12-weeks, and 6-month follow-up. The primary outcome measure was the Goal Attainment Scaling at 12 weeks. Data was also collected in the domains of cognition, quality of life, and mood.

Results: One hundred and eighteen people with MS and cognitive difficulties were randomised to either usual care (n = 60) or COB-MS intervention (n = 58). Ninety-four participants were retained at 6-month follow-up. The COB-MS was found to be feasible, including trial procedures and protocol. Data indicates that the COB-MS is accepted by participants and had positive impacts on daily life. Those allocated to the COB-MS group had a significant improvement in the primary outcome compared to the control condition. Progression criteria set for the feasibility trial have been met therefore further testing of the COB-MS at a definitive trial is supported by the results.

Conclusion: The results provide a strong basis for a pathway to a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy.

Trial Registration: ISRCTN11462710 Date of registration: 4th September 2019.

Original language	English
Pages (from-to)	445-462
Number of pages	18
Journal	Neurological Sciences
Volume	46
Issue number	1
DOIs	https://doi.org/10.1007/s10072-024-07757-5
Publication status	Published - Jan 2025

Keywords

Cluster randomised controlled trial
Cognitive rehabilitation
Feasibility
Multiple sclerosis
Occupational therapy

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Cite this

Hynes, S. M., Dwyer, C. P., Alvarez-Iglesias, A., Rogers, F., Joyce, R. A., Oglesby, M. H., Moses, A., Bane, E., Counihan, T. J., Charamba, B., & COB-MS PPI Advisory Panel 1 (2025). A cluster-randomised controlled feasibility trial evaluating the Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS). Neurological Sciences, 46(1), 445-462. https://doi.org/10.1007/s10072-024-07757-5

@article{890d806c67f74d88a358c981a43baa77,

title = "A cluster-randomised controlled feasibility trial evaluating the Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS)",

abstract = "Introduction: There is a high prevalence of cognitive difficulties in MS, but despite this, there are few programmes targeting cognition that focus on the ability to function well in everyday life. The Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS), an occupation-focused cognitive intervention, was developed to address this. It addresses both the functional difficulties and the wide-ranging symptoms that present in MS.Objective: Here we report on the results of a cluster-randomised controlled feasibility trial (ISRCTN11462710; registered 4th September 2019) evaluating the COB-MS in terms of feasibility and initial efficacy as a cognitive intervention for people with MS.Method: The eight-session COB-MS intervention was delivered remotely by occupational therapists to participants with MS in the intervention group. Following the end of the trial the COB-MS was delivered to the wait-list control group. Data was collected from people with MS experiencing cognitive difficulties at baseline, post-intervention, 12-weeks, and 6-month follow-up. The primary outcome measure was the Goal Attainment Scaling at 12 weeks. Data was also collected in the domains of cognition, quality of life, and mood.Results: One hundred and eighteen people with MS and cognitive difficulties were randomised to either usual care (n = 60) or COB-MS intervention (n = 58). Ninety-four participants were retained at 6-month follow-up. The COB-MS was found to be feasible, including trial procedures and protocol. Data indicates that the COB-MS is accepted by participants and had positive impacts on daily life. Those allocated to the COB-MS group had a significant improvement in the primary outcome compared to the control condition. Progression criteria set for the feasibility trial have been met therefore further testing of the COB-MS at a definitive trial is supported by the results.Conclusion: The results provide a strong basis for a pathway to a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy.Trial Registration: ISRCTN11462710 Date of registration: 4th September 2019.",

keywords = "Cluster randomised controlled trial, Cognitive rehabilitation, Feasibility, Multiple sclerosis, Occupational therapy",

author = "Hynes, \{Sin{\'e}ad M.\} and Dwyer, \{Christopher P.\} and Alberto Alvarez-Iglesias and Fionnuala Rogers and Joyce, \{Robert A.\} and Oglesby, \{Megan H.\} and Anusha Moses and Eimear Bane and Counihan, \{Timothy J.\} and Beatrice Charamba and \{COB-MS PPI Advisory Panel 1\}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",

year = "2025",

month = jan,

doi = "10.1007/s10072-024-07757-5",

language = "English",

volume = "46",

pages = "445--462",

journal = "Neurological Sciences",

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Hynes, SM, Dwyer, CP, Alvarez-Iglesias, A, Rogers, F, Joyce, RA, Oglesby, MH, Moses, A, Bane, E, Counihan, TJ, Charamba, B & COB-MS PPI Advisory Panel 1 2025, 'A cluster-randomised controlled feasibility trial evaluating the Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS)', Neurological Sciences, vol. 46, no. 1, pp. 445-462. https://doi.org/10.1007/s10072-024-07757-5

TY - JOUR

T1 - A cluster-randomised controlled feasibility trial evaluating the Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS)

AU - Hynes, Sinéad M.

AU - Dwyer, Christopher P.

AU - Alvarez-Iglesias, Alberto

AU - Rogers, Fionnuala

AU - Joyce, Robert A.

AU - Oglesby, Megan H.

AU - Moses, Anusha

AU - Bane, Eimear

AU - Counihan, Timothy J.

AU - Charamba, Beatrice

AU - COB-MS PPI Advisory Panel 1

PY - 2025/1

Y1 - 2025/1

N2 - Introduction: There is a high prevalence of cognitive difficulties in MS, but despite this, there are few programmes targeting cognition that focus on the ability to function well in everyday life. The Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS), an occupation-focused cognitive intervention, was developed to address this. It addresses both the functional difficulties and the wide-ranging symptoms that present in MS.Objective: Here we report on the results of a cluster-randomised controlled feasibility trial (ISRCTN11462710; registered 4th September 2019) evaluating the COB-MS in terms of feasibility and initial efficacy as a cognitive intervention for people with MS.Method: The eight-session COB-MS intervention was delivered remotely by occupational therapists to participants with MS in the intervention group. Following the end of the trial the COB-MS was delivered to the wait-list control group. Data was collected from people with MS experiencing cognitive difficulties at baseline, post-intervention, 12-weeks, and 6-month follow-up. The primary outcome measure was the Goal Attainment Scaling at 12 weeks. Data was also collected in the domains of cognition, quality of life, and mood.Results: One hundred and eighteen people with MS and cognitive difficulties were randomised to either usual care (n = 60) or COB-MS intervention (n = 58). Ninety-four participants were retained at 6-month follow-up. The COB-MS was found to be feasible, including trial procedures and protocol. Data indicates that the COB-MS is accepted by participants and had positive impacts on daily life. Those allocated to the COB-MS group had a significant improvement in the primary outcome compared to the control condition. Progression criteria set for the feasibility trial have been met therefore further testing of the COB-MS at a definitive trial is supported by the results.Conclusion: The results provide a strong basis for a pathway to a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy.Trial Registration: ISRCTN11462710 Date of registration: 4th September 2019.

AB - Introduction: There is a high prevalence of cognitive difficulties in MS, but despite this, there are few programmes targeting cognition that focus on the ability to function well in everyday life. The Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS), an occupation-focused cognitive intervention, was developed to address this. It addresses both the functional difficulties and the wide-ranging symptoms that present in MS.Objective: Here we report on the results of a cluster-randomised controlled feasibility trial (ISRCTN11462710; registered 4th September 2019) evaluating the COB-MS in terms of feasibility and initial efficacy as a cognitive intervention for people with MS.Method: The eight-session COB-MS intervention was delivered remotely by occupational therapists to participants with MS in the intervention group. Following the end of the trial the COB-MS was delivered to the wait-list control group. Data was collected from people with MS experiencing cognitive difficulties at baseline, post-intervention, 12-weeks, and 6-month follow-up. The primary outcome measure was the Goal Attainment Scaling at 12 weeks. Data was also collected in the domains of cognition, quality of life, and mood.Results: One hundred and eighteen people with MS and cognitive difficulties were randomised to either usual care (n = 60) or COB-MS intervention (n = 58). Ninety-four participants were retained at 6-month follow-up. The COB-MS was found to be feasible, including trial procedures and protocol. Data indicates that the COB-MS is accepted by participants and had positive impacts on daily life. Those allocated to the COB-MS group had a significant improvement in the primary outcome compared to the control condition. Progression criteria set for the feasibility trial have been met therefore further testing of the COB-MS at a definitive trial is supported by the results.Conclusion: The results provide a strong basis for a pathway to a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy.Trial Registration: ISRCTN11462710 Date of registration: 4th September 2019.

KW - Cluster randomised controlled trial

KW - Cognitive rehabilitation

KW - Feasibility

KW - Multiple sclerosis

KW - Occupational therapy

UR - https://www.scopus.com/pages/publications/85204643656

U2 - 10.1007/s10072-024-07757-5

DO - 10.1007/s10072-024-07757-5

M3 - Article

C2 - 39313688

AN - SCOPUS:85204643656

SN - 1590-1874

VL - 46

SP - 445

EP - 462

JO - Neurological Sciences

JF - Neurological Sciences

IS - 1

ER -

A cluster-randomised controlled feasibility trial evaluating the Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS)

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Keywords

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