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

A resilience group training program for people with multiple sclerosis: multi-centre randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67194859
Enrollment
240
Registered
2020-05-14
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis Nervous System Diseases Multiple sclerosis

Interventions

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 approxima

Sponsors

Istituto Neurologico Carlo Besta
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Severe cognitive compromise (Mini Mental State Examination <19) 2. Psychosis or other serious psychiatric conditions 3. Psychotherapy in the preceding six months 4. Prior formal training in mindfulness methods or current meditation practice 5. Severe suicidality, including ideation, plan and intent 6. One or more relapses in the previous month 7. Corticosteroid treatment during the previous month 8. Other serious medical disorders in addition to MS 9. Current pregnancy 10. MS diagnosis for less than three months

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Current secondary outcome measures as of 09/04/2021: 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 psychological flexibility subscale of The Multidimensional Psychological Flexibility Inventory, MPFI) Previous secondary outcome measures: 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)

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Sep 9, 2026