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

Completed (inferred)MS (type not specified)ISRCTN67194859

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What it measured

Main measures

  • 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)

    MRI lesions

Other measures (1)

  • 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 q

    MRI lesionsMood and sleepQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 100

Show the full criteria

Inclusion criteria

Inclusion: 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: 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

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Background and study aims Multiple sclerosis (MS) is a condition that can affect the brain and spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance. It's a lifelong condition that can sometimes cause serious disability, although it can occasionally be mild. In many cases, it's possible to treat symptoms. Average life expectancy is slightly reduced for people with MS. It's most commonly diagnosed in people in their 20s and 30s, although it can develop at any age. It's about 2 to 3 times more common in women than men. MS is one of the most common causes of disability in younger adults. Adjusting to MS can be highly demanding, and the disease can be a consistent source of stress. Resilience is an internal resource for alleviating the adverse effects of stress and sustaining good mental health through adversity. In recent years, an Australian team developed and tested an Acceptance and Commitment Therapy (ACT)-based group resilience-training program: the REsilience and Activities for every DaY (READY). In view of the promising preliminary data on the READY for MS resilience training intervention, we decided to apply the READY for MS in Italy and to evaluate the efficacy of the program by following the Medical Research Council (MRC) framework for developing and evaluating complex interventions. Aim: This study aims to evaluate the efficacy of the Italian READY for MS program in a multi-center cluster randomized trial. Who can participate? Adults over 18 years, diagnosed with MS. What does the study involve? Participants will be randomly allocated to receive the READY intervention consisting of seven weekly 2.5 hour sessions plus a 2.5 hour ‘booster’ session approximately five weeks after the seventh session, or a control program with the same number of sessions and schedules (but with different content). What are the possible benefits and risks of participating? This study will produce evidence on the efficacy of a brief, structured group intervention to promote resilience in people with MS by comparing it with an active group intervention. It is expected that, by empowering participant inner resources, Italian READY for MS can promote a personal growth that may help participants to prevent or overcome difficulties in adjustment to MS, and to live a full and rich life. The Italian READY for MS program is brief and highly structured, which ease its affordability. We do not expect any negative effects due to the participation in this study. Where is the study run from? Fondazione IRCCS Istituto Neurologico Carlo Besta (Italy) When is the study starting and how long is it expected to run for? January 2020 to December 2022 (updated 09/04/2021, previously: December 2021; updated 20/10/2020, previously: September 2021) Who is funding the study? Fondazione Italiana Sclerosi Multipla – FISM (Italy) Who is the main contact? Ambra Mara Giovannetti, ambra.giovannetti@istituto-besta.it

Papers

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History

    1. Started

      Sept 2021

    2. Finished

      Dec 2022

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