A group resilience training program for people with multiple sclerosis: Study protocol of a multi-centre...

Area of Science:

• Rehabilitation psychology
• Clinical psychology
• Neuroscience

Background:

• The REsilience and Activities for every DaY (READY) program is an Acceptance and Commitment Therapy-based group resilience-training intervention.
• Preliminary evidence suggests READY promotes quality of life and psychosocial outcomes in people with multiple sclerosis (PwMS).
• A phase III randomized controlled trial (RCT) protocol is described, following a pilot RCT, adhering to the Medical Research Council framework for complex interventions.

Purpose of the Study:

• To describe the protocol for a phase III multi-centre cluster RCT evaluating the READY program.
• To compare the efficacy of the READY program against a group relaxation program in PwMS.
• To contribute to the evidence base for READY's efficacy and effectiveness in MS rehabilitation settings.

Main Methods:

• A multi-centre cluster RCT involving 240 PwMS across eight Italian centres.
• Comparison of the READY program with a group relaxation program, both consisting of 7 weekly sessions and a booster session.
• Assessment of resilience (primary outcome), mood, quality of life, well-being, and psychological flexibility at multiple time points.
• Intention-to-treat analysis using repeated-measures, hierarchical generalized linear mixed models to show superiority of READY.
• Contingency plan for teleconferencing intervention delivery due to potential COVID-19 disruptions, with an ancillary study on COVID-19-related distress.

Main Results:

• The study is designed to demonstrate the superiority of the READY program over a group relaxation program.
• Primary outcome is resilience, with secondary outcomes including mood, health-related quality of life, well-being, and psychological flexibility.
• Data will be analyzed to compare longitudinal changes between the two intervention arms.

Conclusions:

• This study is expected to provide robust evidence on the efficacy and effectiveness of the READY program.
• Findings will be compared against an active group intervention in clinical and rehabilitation settings for multiple sclerosis.
• Results will be disseminated through peer-reviewed publications and conference presentations.