Condition category
Nervous System Diseases
Date applied
08/05/2020
Date assigned
14/05/2020
Last edited
14/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Ambra Mara Giovannetti

ORCID ID

http://orcid.org/0000-0002-7496-6727

Contact details

Fondazione IRCCS Istituto Neurologico Carlo Besta
Via Celoria 11
Milano
20133
Italy
+39 (0)223942488
ambra.giovannetti@istituto-besta.it

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

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

Acronym

Multi_READY for MS

Study hypothesis

Participants in the Italian READY for MS would show higher improvements on the primary outcome of resilience (CD-RISC 25) and on the secondary outcomes of mood (The Hospital Anxiety and Depression Scale, HADS; The Positive and Negative Affect Schedule, PANAS), health related quality of life (54-items MS Quality of Life inventory, MSQOL-54; the European Quality of life Five Dimensions, EQ-5D-3L), well-being (The short form of the Mental Health Continuum, MHC-SF) and psychological flexibility (The Comprehensive assessment Acceptance and Commitment Therapy processes, CompACT), compared to the control group (relaxation).

Ethics approval

Approved 15/04/2020, Ethics committees of the Fondazione IRCCS Istituto Neurologico Carlo Besta (Via Celoria 11, Milano, 20133, Italy; +39 (0)2 2394.2321; comitatoetico@istituto-besta.it), ref: 71

Study design

Multi-centre cluster randomised trial with an active control

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Multiple sclerosis

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 the study coordinator and centre PI. The interventions will start within two weeks of the baseline assessment.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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 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)

Overall trial start date

01/01/2020

Overall trial end date

30/09/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A sample size of 12 clusters per treatment arm (total number of clusters=24) with 10 individuals per cluster (total sample size 240)

Participant 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

Recruitment start date

01/09/2020

Recruitment end date

31/01/2021

Locations

Countries of recruitment

Italy

Trial participating centre

Fondazione IRCCS Istituto Neurologico Carlo Besta
Servizio di Neuroepidemiologia Centro Sclerosi Multipla Via Celoria 11
Milan
20133
Italy

Trial participating centre

Azienda Ospedaliera San Camillo - Forlanini
Centro Sclerosi Multipla Circonvallazione Gianicolense, 87
Roma
00149
Italy

Trial participating centre

Servizio di riabilitazione AISM
Via Operai 30
Genova
16149
Italy

Trial participating centre

Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele"
Centro sclerosi multipla Via S. Sofia, 78
Catania
95123
Italy

Trial participating centre

UOSD psicologia clinica e UOC neurologia, ASST Lariana
Laboratorio di neuropsicologia Via Napoleona 60
Como
22100
Italy

Trial participating centre

IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino di Pavia
Centro Sclerosi Multipla Divisione di Neurologia Generale Via Mondino, 2
Pavia
27100
Italy

Trial participating centre

Ospedale "San Giovanni Battista"
Dipartimento Riabilitazione ASLUMBRIA2 via Massimo Arcamone
Foligno
06034
Italy

Trial participating centre

Università di Perugia
Centro Malattie Demielinizzanti e Laboratori di Neurologia Sperimentale Clinica Neurologica Piazzale Giorgio Menghini, 1
Perugia
06129
Italy

Sponsor information

Organisation

Istituto Neurologico Carlo Besta

Sponsor details

Department of Research and Clinical Development
Scientific Directorate
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milano
20133
Italy
+39 (0)2 2394 3568
crc@istituto-besta.it

Sponsor type

Research organisation

Website

http://www.istituto-besta.it

Funders

Funder type

Charity

Funder name

Fondazione Italiana Sclerosi Multipla

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during the current study will be available upon request from Ambra Mara Giovannetti (ambra.giovannetti@istituto-besta.it). Data will be available after publication once the research team will end the dissemination process. People interested in receiving the data will need to ask and present a specific project on data use and ask the study SC for the approval.
The person interested in using data will be in charge for obtaining the consent from participants for that specific use of the data.

Intention to publish date

31/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/05/2020: Trial’s existence confirmed by Ethics committees of the Fondazione IRCCS Istituto Neurologico Carlo Besta.