A resilience group training program for people with multiple sclerosis: multi-centre trial (Multi_READY for MS)

INTERVENTION: READY for MS is an adult ACT (Acceptance and Commitment Therapy) informed group resilience training program which consists of seven weekly 2.5 hour sessions plus a 2.5 hour ‘booster’ session approximately five weeks after the seventh session. Content of the seven weekly sessions is as follows: an introductory module (Introduction to the READY Resilience Model), five modules focusing on each of the six ACT processes (Mindfulness, Acceptance, Cognitive Defusion, Self‐as‐Context, Values, Meaningful Action), and a review module (Review and Future Planning). The booster session provides a review of the program content. The control program will match the study intervention in the number of sessions and schedules (but not in session content and length). Patient‐reported outcome measures (PROMs) will be assessed immediately before, after the booster session, at three and six‐month follow‐up. Additional process data will capture participants’ attendance, homework completion, and facilitator perspectives on a weekly basis. Each session will be audio‐recorded and self‐rated by the facilitators. Two sessions for each Italian READY for MS group will be randomly selected and independently rated by two ACT experts to assess intervention fidelity. The control group session fidelity will be assessed following the same procedures except for the use of ACT‐FM and audio recording assessment that will be done by one rate. Randomization will be provided by an independent randomization unit, using computer‐based cluster randomization with minimization (2 factors: Centre and CDRISC score < 50 and = 50). Groups will be allocated to Italian READY for MS or control intervention in a 1:1 ratio. Confirmation e‐mails will be sent to CONDITION: Multiple sclerosis ; Nervous System Diseases ; Multiple sclerosis PRIMARY OUTCOME: Psychological resilience measured using the Connor‐Davidson Resilience Scale 25 (CD‐RISC 25) assessed immediately before (baseline visit, T0), after the booster session (T1, 12 weeks after baseline visit), at three (T2, 24 weeks after baseline visit), and six month follow‐up (T2, 36 weeks after baseline visit) SECONDARY OUTCOME: ; Assessed immediately before (baseline visit, T0), after the booster session (T1, 12 weeks after baseline visit), at three (T2, 24 weeks after baseline visit), and six month follow‐up (T2, 36 weeks after baseline visit):; 1. Mood (The Hospital Anxiety and Depression Scale, HADS; The Positive and Negative Affect Schedule, PANAS); 2. Health related quality of life (54‐items MS Quality of Life inventory, MSQOL‐54; the European Quality of life Five Dimensions, EQ‐5D‐3L); 3. Well‐being (The short form of the Mental Health Continuum, MHC‐SF); 4. Psychological flexibility (The Comprehensive assessment Acceptance and Commitment Therapy processes, CompACT); INCLUSION CRITERIA: 1. Diagnosis of MS 2. Age = 18 years 3. Written informed consent 4. Resilience score < 83 5. Able to attend group sessions and fluent Italian speaker