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Co-development of a protocol for a randomised controlled feasibility trial of CIRCuiTS™ cognitive remediation therapy
Rebecca J Thomas1, Matteo Cella2,3, Peter A Brex4
1Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. Rebecca.j.thomas@kcl.ac.uk.
Background:
Cognitive difficulties are common in people with multiple sclerosis (MS) and predict poorer quality of life, yet effective treatment is lacking. Cognitive remediation therapy (CRT) improves functioning in individuals with severe mental health conditions and could benefit people with MS if adequately adapted. Recognising patient and public involvement (PPI) benefits in developing acceptable interventions, this study engaged people with MS to develop a protocol to assess the feasibility of delivering a computerised, therapist-assisted CRT programme (CIRCuiTS™) to people with MS. This paper describes this process and presents the trial protocol, highlighting how PPI informed the study design and treatment implementation.
Methods:
Protocol co-development involved three phases of consultation with people with MS. First, the PPI lead, who has MS, contributed along with mental health professionals to the design draft. Second, co-development using an observational qualitative design was conducted with people with MS in a structured 2-day workshop. Workshop discussions were recorded, transcribed, and analysed thematically to arrive at 24 specific, actionable recommendations. These recommendations, alongside statistical input, guided the trial design. Finally, a separate PPI group provided feedback on the trial documents. The proposed trial will recruit 24 people with MS experiencing cognitive difficulties from a UK NHS service, randomly assigning them to receive a 12-week CIRCuiTS™ MS programme immediately or after a 13-week wait. This relatively short waiting period was recommended as likely to maintain engagement. Standard CIRCuiTS™ delivery will be adapted to MS needs by offering remote sessions, dexterity tailoring and MS-specific therapist training. Primary outcomes are feasibility and acceptability. Guided by PPI-anticipated benefits, the secondary outcomes will be goal attainment, cognition, fatigue, mood, and daily functioning. Two people with MS continue to guide the study in the oversight group and a PPI Advisory group will provide ongoing advice on trial management.
Discussion:
PPI, as recommended in the new CONSORT 2025 statement, strengthened the feasibility and acceptability of the trial by addressing challenges and shaping the protocol. This collaboration enhances the evaluation of CRT for people with MS and provides a model for transparent PPI reporting in trial development.
Trial Registration:
ClinicalTrials.gov ID NCT06877273, 14th March 2025.
