A group resilience training program for people with multiple sclerosis: A cluster-randomized controlled trial (multi-READY for MS).

BACKGROUND

People with multiple sclerosis (PwMS) often experience reduced resilience, the ability to adapt to stressors using internal and external resources. Resilience and Activities for every DaY (READY) is an Acceptance and Commitment Therapy-based group resilience intervention.

OBJECTIVE

To assess the effectiveness of READY versus group relaxation in PwMS with low resilience (Connor-Davidson Resilience Scale 25 [CD-RISC] score < 83).

METHODS

Cluster-randomized controlled trial across seven Italian centers with assessments at baseline, immediately post-intervention, and after 3 and 6 months. The primary outcome was CD-RISC at 3 months. Secondary outcomes include mood, psychological flexibility, well-being, and health-related quality of life (HRQoL).

RESULTS

Of 226 PwMS randomized to 24 groups, 197 were analyzed; 188 completed the trial. At 3 months, CD-RISC improved in both arms (+2.53 READY; +0.43 relaxation; between-arm difference +2.10, 95% CI -1.06 to +5.26; p = 0.193); READY showed greater improvement than relaxation in Anxiety (p = 0.016), Well-being (p = 0.022), Psychological Flexibility (p = 0.033), and generic HRQoL (p = 0.001). At 6 months, differences increased to include depression (p = 0.039). Longitudinal models showed significant within-group improvements in READY across resilience, mood, HRQoL, well-being, and flexibility outcomes.

CONCLUSIONS

READY was not superior for the primary endpoint but was superior for most secondary outcomes.

TRIAL REGISTRATION: ISRCTN67194859 (ISRCTN Registry; https://www.isrctn.com).